Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-31 @ 6:04 AM
Study NCT ID:
NCT02906358
Status:
COMPLETED
Last Update Posted:
2018-11-05
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Chronic Pain Self-Management in Clinic or Community for Low-Income Hispanics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'turner@uthscsa.edu', 'phone': '210-562-5551', 'title': 'Barbara J Turner', 'organization': 'The University of Texas Health Science Center at San Antonio'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Limitations of our study include the absence of a control group to gain clinic support, unanticipated adverse events, challenges recruiting and retaining subjects, lack of long-term follow-up and possible lack of generalizability.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for 11 months, the duration of the program.', 'eventGroups': [{'id': 'EG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour monthly meetings for first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 3, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 2, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sprained wrist', 'notes': 'Patient wore a wrist brace and stated that they have had wrist problems and occasionally use the brace when they have discomfort.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'notes': 'Patient fell while walking inside home after sitting outside with family, a daily routine.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'notes': 'Patient fell back after getting up from a chair in the kitchen.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'notes': 'Patient fell at the grocery store which she stated has happened previously because of problems with balance.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'notes': 'Patient fell at home before the program had started.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fractured leg', 'notes': 'Patient fractured their leg after missing a step while entering the house during a family gathering.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout attack', 'notes': 'Patient went to the hospital for heart attack symptoms and was told he had gout.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic foot infection leading to leg amputation', 'notes': 'Patient had neuropathy and uncontrolled diabetes which caused a leg amputation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Five Times Sit-to-stand (5XSTS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'OG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'classes': [{'title': 'Change from Baseline Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.53', 'spread': '6.78', 'groupId': 'OG000'}, {'value': '-5.20', 'spread': '17.53', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline Score at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.18', 'spread': '6.45', 'groupId': 'OG000'}, {'value': '-6.43', 'spread': '14.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline sit-to-stand at 3 and 6 months', 'description': 'Participants are instructed to sit and stand up five times as fast as they can from a standard armless chair while the researcher times how many seconds it takes them to complete the task. After a brief rest, they repeat the test a second time and the average of two tests is calculated.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.'}, {'type': 'SECONDARY', 'title': '50-foot Speed Walk (50FtSW)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'OG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'classes': [{'title': 'Change from Baseline Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.58', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '4.29', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline Score at 6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.32', 'spread': '7.16', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '4.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline 50-foot speed walk at 3 and 6 months', 'description': 'This test requires participants to walk along a 25-foot walkway turn around and return to the starting point. They are instructed to safely walk as fast as they can and the time taken to complete the test is recorded in seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.'}, {'type': 'SECONDARY', 'title': 'Patient Specific Functional Scale (PSFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'OG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'classes': [{'title': 'Change from Baseline Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '1.66', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline Score at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.64', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '1.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline PSFS at 3 and 6 months', 'description': 'This is a brief, one-page document that prompts subjects to identify limitations to three activities, rank the importance of these activities, and track progress over time. The activities are scored on a scale of 0 to 10, where 0 indicates that the subject is unable to perform the activity and 10 indicates ability to perform the activity at the same level as before the injury or problem. The total summed score is divided by the number of activities, where a lower score would indicate less ability to perform the task, and the higher score would indicate easier performance of the task.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.'}, {'type': 'SECONDARY', 'title': 'Symbol-Digit Modalities Test (SDMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'OG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'classes': [{'title': 'Change from Baseline Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.19', 'spread': '6.61', 'groupId': 'OG000'}, {'value': '6.84', 'spread': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline Score at 6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.61', 'spread': '8.67', 'groupId': 'OG000'}, {'value': '7.37', 'spread': '8.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline SDMT at 3 and 6 months', 'description': 'Participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes (written and oral versions) with the correct digit assigned to a particular symbol. Total correct responses within 90 seconds were measured. The score of the test is the number of correct substitutions completed within the time limit, with a maximum score of 110. A score under 33 is generally considered to be a clear indicator of the existence of some type of cognitive disorder. The higher the score, the better the cognitive function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.'}, {'type': 'SECONDARY', 'title': 'The Brief Pain Inventory (BPI): Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'OG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'classes': [{'title': 'Change from Baseline Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.90', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '2.00', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline Score at 6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.95', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '2.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline BPI at 3 and 6 months', 'description': 'The BPI is brief and uses simple 0-10 rating scales to measure pain intensity, where zero is no pain and ten is most intense pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.'}, {'type': 'SECONDARY', 'title': 'The Brief Pain Inventory (BPI): Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'OG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'classes': [{'title': 'Change from Baseline Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.31', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '4.10', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline Score at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.09', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '2.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline BPI at 3 and 6 months', 'description': 'The BPI is brief and uses simple 0-10 rating scales to measure the degree to which pain interferes with common dimensions of feeling and function, where zero is does not interfere and ten is completely interferes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.'}, {'type': 'SECONDARY', 'title': '6-minute Distance Walk (6MW)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'OG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'spread': '291.9', 'groupId': 'OG000'}, {'value': '193.9', 'spread': '429.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline 6-minute distance walk at 6 months', 'description': "For this test, participants walk as far as they can for six minutes, and the total distance in feet is measured with a surveyor's wheel pushed by a research assistant walking behind the subject. Participants can pause or stop as necessary.", 'unitOfMeasure': 'feet', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.'}, {'type': 'SECONDARY', 'title': 'Borg Perceived Effort (Borg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'OG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '4.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline perceived effort at 6 months', 'description': 'Completed in conjunction with the 6-minute walk, this measures intensity and perceived effort after the test using a 0-10 Likert-type scale. Anchor words for the effort scales are "no effort" and "most intense effort imaginable."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Study 12-Item Short Form Physical Component Summary (SF-12 PCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'OG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'classes': [{'categories': [{'measurements': [{'value': '2.20', 'spread': '8.56', 'groupId': 'OG000'}, {'value': '6.76', 'spread': '9.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline SF-12 PCS at 6 months', 'description': 'The 12-item Short Form Health Survey created for Medical Outcomes Study measures physical summary scores through a brief survey with limited respondent burden while retaining precision. Physical Health Composite Scores are computed using the scores of 12 questions and range from 0 to 100, where 0 indicates the lowest level of health, and 100 indicates the highest level of health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Study 12-Item Short Form Mental Component Summary (SF-12 MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'OG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'classes': [{'categories': [{'measurements': [{'value': '41.44', 'spread': '12.58', 'groupId': 'OG000'}, {'value': '39.39', 'spread': '12.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline SF-12 MCS at 6 months', 'description': 'The 12-item Short Form Health Survey created for Medical Outcomes Study measures mental summary scores through a brief survey with limited respondent burden while retaining precision. Mental Health Composite Scores are computed using the scores of 12 questions and range from 0 to 100, where 0 indicates the lowest level of mental health, and 100 indicates the highest level of mental health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire -9 (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'OG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.08', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '-3.45', 'spread': '6.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline PHQ-9 at 6 months', 'description': 'The PHQ-9 is a brief, self-administered questionnaire that assesses somatic symptom severity. Participants rate the severity of 15 somatic symptoms as 0 (not bothered at all), 1 (bothered a little) or 2 (bothered a lot). The scores are totaled, with a possible total of 30, which would mean the most severe somatic symptoms, and 0 meaning the least somatic symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.'}, {'type': 'SECONDARY', 'title': 'Tampa Scale for Kinesiophobia (TSK)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'OG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.64', 'spread': '6.32', 'groupId': 'OG000'}, {'value': '-2.77', 'spread': '7.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline TSK at 6 months', 'description': 'This is a 11-item questionnaire, where individuals score items on a scale of 1 to 4 (1=strongly disagree, 4=strongly agree) to measures fear of completing physical activities. The scores are totaled for all items, to give a possible score of 44, which would indicate a greater fear of injuring oneself. A lower score would indicate less fear of injury to oneself.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'FG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Completed 3 Month Measures', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'comment': 'Includes participants who completed the entire program and 6 month measures', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Community-based Pain Self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)\n\nCommunity-based pain self-management'}, {'id': 'BG001', 'title': 'Clinic-based Pain Self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)\n\nClinic-based pain self-management'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '56.2', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '56.5', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'Non-Hispanic White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Non-Hispanic Black', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Language', 'classes': [{'categories': [{'title': 'English', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Spanish', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'categories': [{'title': 'Married', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Other (single, divorced, separated, widowed)', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment Status', 'classes': [{'categories': [{'title': 'Employed', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unemployed (retired, disabled, unemployed)', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance Type', 'classes': [{'categories': [{'title': 'Private Insurance', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Medicare', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Medicaid', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unisured', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '33.3', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '34.5', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pain Location', 'classes': [{'categories': [{'title': 'Neck', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Upper Extremity', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Back', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Abdomen', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Lower Extremity', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Multiple areas', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-27', 'studyFirstSubmitDate': '2016-09-07', 'resultsFirstSubmitDate': '2017-08-10', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-27', 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Five Times Sit-to-stand (5XSTS)', 'timeFrame': 'Change from Baseline sit-to-stand at 3 and 6 months', 'description': 'Participants are instructed to sit and stand up five times as fast as they can from a standard armless chair while the researcher times how many seconds it takes them to complete the task. After a brief rest, they repeat the test a second time and the average of two tests is calculated.'}], 'secondaryOutcomes': [{'measure': '50-foot Speed Walk (50FtSW)', 'timeFrame': 'Change from Baseline 50-foot speed walk at 3 and 6 months', 'description': 'This test requires participants to walk along a 25-foot walkway turn around and return to the starting point. They are instructed to safely walk as fast as they can and the time taken to complete the test is recorded in seconds.'}, {'measure': 'Patient Specific Functional Scale (PSFS)', 'timeFrame': 'Change from Baseline PSFS at 3 and 6 months', 'description': 'This is a brief, one-page document that prompts subjects to identify limitations to three activities, rank the importance of these activities, and track progress over time. The activities are scored on a scale of 0 to 10, where 0 indicates that the subject is unable to perform the activity and 10 indicates ability to perform the activity at the same level as before the injury or problem. The total summed score is divided by the number of activities, where a lower score would indicate less ability to perform the task, and the higher score would indicate easier performance of the task.'}, {'measure': 'Symbol-Digit Modalities Test (SDMT)', 'timeFrame': 'Change from Baseline SDMT at 3 and 6 months', 'description': 'Participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes (written and oral versions) with the correct digit assigned to a particular symbol. Total correct responses within 90 seconds were measured. The score of the test is the number of correct substitutions completed within the time limit, with a maximum score of 110. A score under 33 is generally considered to be a clear indicator of the existence of some type of cognitive disorder. The higher the score, the better the cognitive function.'}, {'measure': 'The Brief Pain Inventory (BPI): Severity', 'timeFrame': 'Change from Baseline BPI at 3 and 6 months', 'description': 'The BPI is brief and uses simple 0-10 rating scales to measure pain intensity, where zero is no pain and ten is most intense pain imaginable.'}, {'measure': 'The Brief Pain Inventory (BPI): Interference', 'timeFrame': 'Change from Baseline BPI at 3 and 6 months', 'description': 'The BPI is brief and uses simple 0-10 rating scales to measure the degree to which pain interferes with common dimensions of feeling and function, where zero is does not interfere and ten is completely interferes.'}, {'measure': '6-minute Distance Walk (6MW)', 'timeFrame': 'Change from Baseline 6-minute distance walk at 6 months', 'description': "For this test, participants walk as far as they can for six minutes, and the total distance in feet is measured with a surveyor's wheel pushed by a research assistant walking behind the subject. Participants can pause or stop as necessary."}, {'measure': 'Borg Perceived Effort (Borg)', 'timeFrame': 'Change from Baseline perceived effort at 6 months', 'description': 'Completed in conjunction with the 6-minute walk, this measures intensity and perceived effort after the test using a 0-10 Likert-type scale. Anchor words for the effort scales are "no effort" and "most intense effort imaginable."'}, {'measure': 'Medical Outcomes Study 12-Item Short Form Physical Component Summary (SF-12 PCS)', 'timeFrame': 'Change from Baseline SF-12 PCS at 6 months', 'description': 'The 12-item Short Form Health Survey created for Medical Outcomes Study measures physical summary scores through a brief survey with limited respondent burden while retaining precision. Physical Health Composite Scores are computed using the scores of 12 questions and range from 0 to 100, where 0 indicates the lowest level of health, and 100 indicates the highest level of health.'}, {'measure': 'Medical Outcomes Study 12-Item Short Form Mental Component Summary (SF-12 MCS)', 'timeFrame': 'Change from baseline SF-12 MCS at 6 months', 'description': 'The 12-item Short Form Health Survey created for Medical Outcomes Study measures mental summary scores through a brief survey with limited respondent burden while retaining precision. Mental Health Composite Scores are computed using the scores of 12 questions and range from 0 to 100, where 0 indicates the lowest level of mental health, and 100 indicates the highest level of mental health.'}, {'measure': 'Patient Health Questionnaire -9 (PHQ-9)', 'timeFrame': 'Change from Baseline PHQ-9 at 6 months', 'description': 'The PHQ-9 is a brief, self-administered questionnaire that assesses somatic symptom severity. Participants rate the severity of 15 somatic symptoms as 0 (not bothered at all), 1 (bothered a little) or 2 (bothered a lot). The scores are totaled, with a possible total of 30, which would mean the most severe somatic symptoms, and 0 meaning the least somatic symptoms.'}, {'measure': 'Tampa Scale for Kinesiophobia (TSK)', 'timeFrame': 'Change from Baseline TSK at 6 months', 'description': 'This is a 11-item questionnaire, where individuals score items on a scale of 1 to 4 (1=strongly disagree, 4=strongly agree) to measures fear of completing physical activities. The scores are totaled for all items, to give a possible score of 44, which would indicate a greater fear of injuring oneself. A lower score would indicate less fear of injury to oneself.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '25581257', 'type': 'BACKGROUND', 'citation': 'Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.'}, {'pmid': '16054407', 'type': 'BACKGROUND', 'citation': 'Jensen MK, Thomsen AB, Hojsted J. 10-year follow-up of chronic non-malignant pain patients: opioid use, health related quality of life and health care utilization. Eur J Pain. 2006 Jul;10(5):423-33. doi: 10.1016/j.ejpain.2005.06.001. Epub 2005 Jul 28.'}, {'pmid': '7154893', 'type': 'BACKGROUND', 'citation': 'Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.'}, {'pmid': '16962238', 'type': 'BACKGROUND', 'citation': 'French DJ, France CR, Vigneau F, French JA, Evans RT. Fear of movement/(re)injury in chronic pain: a psychometric assessment of the original English version of the Tampa scale for kinesiophobia (TSK). Pain. 2007 Jan;127(1-2):42-51. doi: 10.1016/j.pain.2006.07.016. Epub 2006 Sep 7.'}, {'pmid': '16055269', 'type': 'BACKGROUND', 'citation': 'Woby SR, Roach NK, Urmston M, Watson PJ. Psychometric properties of the TSK-11: a shortened version of the Tampa Scale for Kinesiophobia. Pain. 2005 Sep;117(1-2):137-44. doi: 10.1016/j.pain.2005.05.029.'}, {'type': 'BACKGROUND', 'citation': 'Simmonds MJ, Ortega C, Simmonds KP. Pain, Emotion and Cognition. ln: Pickering G, Gibson S, eds. Switzerland: Springer International Publishing; c2015. Chapter 11, Physical Therapy and Exercise: Impacts on Pain, Mood, Cognition, and Function; p. 167-186.'}, {'type': 'BACKGROUND', 'citation': 'Smith A. Symbol Digits Modalities Test. Western Psychological Services: Los Angeles, 1982.'}, {'pmid': '27793191', 'type': 'BACKGROUND', 'citation': 'Valerio MA, Rodriguez N, Winkler P, Lopez J, Dennison M, Liang Y, Turner BJ. Comparing two sampling methods to engage hard-to-reach communities in research priority setting. BMC Med Res Methodol. 2016 Oct 28;16(1):146. doi: 10.1186/s12874-016-0242-z.'}, {'type': 'BACKGROUND', 'citation': 'Butler DS, Moseley GL. Explain Pain. Adeliade, South Australia: Noigroup Publications; 2013.'}, {'pmid': '23783372', 'type': 'BACKGROUND', 'citation': 'Jones SE, Kon SS, Canavan JL, Patel MS, Clark AL, Nolan CM, Polkey MI, Man WD. The five-repetition sit-to-stand test as a functional outcome measure in COPD. Thorax. 2013 Nov;68(11):1015-20. doi: 10.1136/thoraxjnl-2013-203576. Epub 2013 Jun 19.'}, {'pmid': '11856064', 'type': 'BACKGROUND', 'citation': 'Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.'}, {'pmid': '17065542', 'type': 'BACKGROUND', 'citation': 'Smeets RJ, Hijdra HJ, Kester AD, Hitters MW, Knottnerus JA. The usability of six physical performance tasks in a rehabilitation population with chronic low back pain. Clin Rehabil. 2006 Nov;20(11):989-97. doi: 10.1177/0269215506070698.'}, {'pmid': '21904240', 'type': 'BACKGROUND', 'citation': 'Bohannon RW. Test-retest reliability of the five-repetition sit-to-stand test: a systematic review of the literature involving adults. J Strength Cond Res. 2011 Nov;25(11):3205-7. doi: 10.1519/JSC.0b013e318234e59f.'}, {'type': 'BACKGROUND', 'citation': 'Ware JE, Kosinski M, Keller SD. SF-12: How to Score the SF-12 Physical and Mental Health Summary Scales. 2nd ed. Boston: The Health Institute; 1995.'}, {'pmid': '24828475', 'type': 'BACKGROUND', 'citation': 'Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014 Aug;44(8):560-4. doi: 10.2519/jospt.2014.5248. Epub 2014 May 14.'}, {'pmid': '11556941', 'type': 'BACKGROUND', 'citation': 'Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.'}, {'pmid': '8080219', 'type': 'BACKGROUND', 'citation': 'Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.'}, {'pmid': '30312459', 'type': 'DERIVED', 'citation': 'Turner BJ, Rodriguez N, Bobadilla R, Hernandez AE, Yin Z. Chronic Pain Self-Management Program for Low-Income Patients: Themes from a Qualitative Inquiry. Pain Med. 2020 Feb 1;21(2):e1-e8. doi: 10.1093/pm/pny192.'}, {'pmid': '29299814', 'type': 'DERIVED', 'citation': 'Turner BJ, Liang Y, Simmonds MJ, Rodriguez N, Bobadilla R, Yin Z. Randomized Trial of Chronic Pain Self-Management Program in the Community or Clinic for Low-Income Primary Care Patients. J Gen Intern Med. 2018 May;33(5):668-677. doi: 10.1007/s11606-017-4244-2. Epub 2018 Jan 3.'}], 'seeAlsoLinks': [{'url': 'http://aspe.hhs.gov/sp/reports/2015/OpioidInitiative/ib_OpioidInitiative.pdf', 'label': 'Department of Health and Human Services: ASPE Issue Brief. Opioid Abuse in the U.S. and HHS Actions to Address Opioid-Drug Related Overdoses and Deaths'}, {'url': 'http://www.pgapworks.com/en/whatisthepgap/index.php', 'label': 'The Progressive Goal Attainment Program (PGAP®). An Evidence-Based Treatment Program for Reducing Disability Associated with Pain, Depression, Cancer and other Chronic Health Conditions.'}, {'url': 'http://www.paintoolkit.org/', 'label': 'Moore P, Cole F. The Pain Toolkit.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a parallel group, randomized trial of a chronic pain self-management program in clinic or community settings to educate and support low-income, Hispanic patients with chronic pain to adopt evidence-based pain self-care behaviors and activities.', 'detailedDescription': "Background and Significance\n\nOver the past two decades, opioid analgesic (OA) drugs have been increasingly prescribed for chronic pain despite little to no effectiveness of treatment \\>6 months. In prospective cohorts, OA therapy can worsen pain and disability by promoting a sedentary lifestyle. With rapidly rising deaths from OA overdose and the lack of evidence of long-term effectiveness, the U.S. Department of Health and Human Services (HHS) has developed its National Pain Strategy that sharply limits use of OAs and recommends non-pharmacologic interventions as first line approaches to manage chronic pain. A key aspect of a non-pharmacologic approach to managing chronic pain is educating patients about self-management in order to help them lead more productive lives and perform daily activities despite their pain. Self-management training is especially important for low-income patients who need practical, low cost ways to learn how to live fuller, more productive lives despite having chronic pain. To respond to this need to support low-income patients with chronic pain, we developed a chronic pain self-management program based on unmet needs identified by stakeholders from rural, largely Hispanic communities. We conducted a randomized trial to examine outcomes of two settings to deliver this self-management training program. Both settings evaluated whether patients' function improved when the same program was delivered in clinic in individual meetings with a trained community health worker or in a local community-based setting from group lectures by content experts. The training program in both settings offered education and training about such topics as: pain physiology and goal setting; stretching; strengthening; massage, and mindfulness techniques. This program not only reflects the unmet needs of rural, predominantly Hispanic stakeholders with chronic pain but also elements of other self-management programs for patients with chronic back and lower extremity musculoskeletal pain. However, this program was specifically designed for a low literacy, bilingual patient population with limited access to resources to help with non-pharmacologic management of chronic pain.\n\nObjective:\n\nTo develop a chronic pain self-management program reflecting community stakeholders' priorities and conduct a randomized trial to evaluate functional outcomes from training in two settings. Subjects will be randomized to receive a 6-month pain self-management training program in: 1) Six 30-to-45 minute individual meetings with a trained community health worker in clinic or 2) nine 1-hour meetings for group lectures by content experts and practicing physical activities held in nearby public libraries.\n\nStudy Design:\n\nThe investigators conducted a parallel group, randomized trial of clinic- and community-based programs to educate and promote pain self-management among low-income, predominantly Hispanic patients aged 35-70 who had been prescribed at least two months of OA therapy for chronic non-cancer back and lower extremity pain. Patients were recruited from two primary care clinics and one HIV clinic that treat low-income patients. A total of 111 subjects were randomized to: 1) clinic-based meetings one-on-one with a trained community health worker, or 2) a community-based program in a local library with group lectures by content experts and training in exercises. The same low literacy PowerPoint educational program in Spanish or English was presented to both study arms except in the community, eight lectures about chronic pain self-management were presented plus one lecture about using library resources (biweekly for three months then monthly for three months). Whereas, in the clinic arm, the content was condensed to be covered in six monthly 30-45 minute meetings with the community health worker. To increase availability for subjects in the community arm, the same group session was offered twice a week. Sessions included: 1) Orientation to the pain program; 2) Pain physiology exercises/stretching; 3) Stress management and mindfulness; 4) Massage therapy approaches; 5) Nutrition; 6) Sleep hygiene; 7) Relapse prevention; 8) Health literacy (Internet resources); and 9) Review and long-term pain self-management strategies. To keep the group size manageable, the pain self-management program was held in two cohorts to meet library and clinic space limitations.\n\nAll subjects received copies of slides from sessions with photos of local Hispanic community members performing stretching and strengthening exercises at different levels of difficulty. Participants also received activity logs to track personal goals, program DVDs (walking exercises, self-massage techniques), exercise mats, tennis balls for massage and multi-pronged self-massage tools. Physical therapy students helped patients select personalized goals for physical activities. All participants received text messages and phone calls from a coordinator (community) or a community health worker (clinic) to review progress and reinforce meeting attendance. Missed sessions were made up with a coordinator (community arm) or a community health worker (clinic arm).\n\nBaseline and follow-up measures were conducted by physical therapy students, CHWs, or team members not involved in that study arm. Twelve measures of physical, cognitive, and psychological, function and pain were assessed at 6 months in the clinic or the community location and 6 of these were also assessed at 3 months. The primary outcome measure was the five times sit-to-stand test (5XSTS) that was assessed at both 3 and 6 months and reflects both lower extremity strength and balance. The 5XSTS is significantly associated with disability and risk of falls. Secondary outcomes include: 6-minute distance walk test (6MW); Borg Perceived Effort test (Borg effort); 50-foot speed walk test (50FtSW); 12-Item Short Form Survey Physical Component Summary (SF-12 PCS); and Patient Specific Functional Scale (PSFS). Measures of psychological function include: 12-Item Short Form Survey Mental Component Summary (SF-12 MCS), Brief Pain Inventory (BPI), Patient Health Questionnaire-9 (PHQ-9) and the Tampa Scale for Kinesiophobia (TSK). To assess cognitive function, the Symbol-Digit Modalities Test (SDMT) evaluates attention and psychomotor speed. All measures were performed at baseline and the 6-month study endpoint except the following measures also assessed at three months: 5XSTS, 50FtSW, BPI, PSFS and SDMT. These are all validated functional measures (see below). The practical self-management training program evaluated in this trial may offer a valuable resource for primary care practices striving to support their patients with chronic pain, especially those with limited access to other resources.\n\nImpact:\n\nIf either or both of the approaches to deliver this chronic pain self-management training program improve patient functional outcomes, they can be easily replicated to evaluate in other low-income populations to improve function and possibly even reduce dependence on OA therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active patient in two study primary care clinics or HIV clinic in same system\n* Prescribed OAs \\>2 mos in the past year\n* Back/lower extremity pain\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* Unstable comorbidity\n* Cardiovascular/pulmonary disease that prevents exercise\n* Cancer-related pain\n* Significant mental health disorder\n* Alcohol or drug abuse\n* Inability to walk unassisted for at least one block\n* Inability to provide consent (e.g., dementia)\n* Residing more than 10 miles from clinic (poor transportation)\n* Patients who are unable or unwilling to attend clinic- or community-based sessions'}, 'identificationModule': {'nctId': 'NCT02906358', 'briefTitle': 'Trial of Chronic Pain Self-Management in Clinic or Community for Low-Income Hispanics', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Evaluating Clinic- and Community-Based Pain Self-Care Programs for Low-Income Hispanics on Opioids', 'orgStudyIdInfo': {'id': 'HSC20150600H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Community-based pain self-management', 'description': 'Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)', 'interventionNames': ['Behavioral: Community-based pain self-management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clinic-based pain self-management', 'description': 'Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)', 'interventionNames': ['Behavioral: Clinic-based pain self-management']}], 'interventions': [{'name': 'Community-based pain self-management', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Community-based pain self-management']}, {'name': 'Clinic-based pain self-management', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Clinic-based pain self-management']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Barbara J Turner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Health Science Center at San Antonio'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of Texas at San Antonio', 'class': 'OTHER'}, {'name': 'Bexar County Hospital District DBA University Health System', 'class': 'OTHER'}, {'name': 'San Antonio Public Libraries', 'class': 'UNKNOWN'}, {'name': 'South Central Area Health Education Center', 'class': 'UNKNOWN'}, {'name': 'The University of Texas System Healthcare Safety & Effectiveness Grants Program', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}