Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-06 @ 1:28 PM
Study NCT ID:
NCT02262234
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2014-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-08', 'studyFirstSubmitDate': '2014-10-07', 'studyFirstSubmitQcDate': '2014-10-07', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain interference with activities', 'timeFrame': 'Week 10 versus baseline', 'description': 'The extent to which pain interferes with daily activities will be measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS). The MPI-LIS is a 10-item self-report of extent of interference of pain with life activities and the enjoyment of life. The subscale will be modified to remove two items related to work, as recommended based on a factor analysis of the subscale in persons with SCI.'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Week 10 versus baseline', 'description': 'Pain intensity will be rated on a 0-10 numerical rating scale (0="no pain" and 10="pain as bad as you can imagine").'}, {'measure': 'Mental health and well-being', 'timeFrame': 'Week 10 versus baseline', 'description': 'The Brief Patient Health Questionnaire and Perceived Stress Scale will be used to assess changes in mental health that occur between baseline and the end of the education program.'}, {'measure': 'Pain attitudes', 'timeFrame': 'Week 10 versus baseline', 'description': 'The Survey of Pain Attitudes will be used to assess changes in thoughts and beliefs about pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinal cord injury', 'Chronic pain', 'Education'], 'conditions': ['Spinal Cord Injury', 'Chronic Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://KesslerFoundation.org', 'label': 'Kessler Foundation Home Page'}]}, 'descriptionModule': {'briefSummary': 'Chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (SCI). Unfortunately, chronic pain is very difficult to treat. Many treatments reduce chronic pain only partially. As a result, many people with SCI must find ways of accomplishing daily activities even though they have pain.\n\nThe purpose of this research study is to determine how well two different kinds of education programs reduce the extent to which chronic pain interferes with daily life and well-being.', 'detailedDescription': 'Pain is a highly prevalent and disabling condition among persons with spinal cord injury (SCI). Unfortunately, current pain treatments offer incomplete relief, produce side effects, and/or involve significant cost. Low-risk, low-cost treatments capable of addressing residual pain and pain-related disability are greatly needed. A number of research studies have associated educational interventions with improvements in pain-related outcomes.\n\nThe overall goal of the proposed pilot study is to evaluate the feasibility, acceptability, and potential benefits of two types of educational programs for people with chronic pain and spinal cord injury. This study aims to identify a low-cost, low-risk treatment option that empowers people with pain and SCI to improve their functioning and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spinal cord injury for at least one year\n* Chronic pain for at least three months that is moderate to severe (rated at or above 4/10 on a scale of 0 to 10 where 0 = "no pain" and 10 = "pain as bad as you can imagine")\n* Fluent in English\n* Not currently starting a new pain treatment or changing a previous pain treatment\n\nExclusion Criteria:\n\n* Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson Disease, Alzheimer\'s disease) and may affect my physical or mental functioning\n* Significant difficulties with learning or memory\n* Previous participation in a health and function education program specifically designed for people with chronic pain and SCI\n* Inability to understand English\n* Presence of other conditions not related to SCI that cause pain (such as fibromyalgia)'}, 'identificationModule': {'nctId': 'NCT02262234', 'briefTitle': 'Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Kessler Foundation'}, 'officialTitle': 'Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study', 'orgStudyIdInfo': {'id': 'R-815-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education Program Type 1', 'interventionNames': ['Other: Education Program Type 1']}, {'type': 'EXPERIMENTAL', 'label': 'Education Program Type 2', 'interventionNames': ['Other: Education Program Type 2']}], 'interventions': [{'name': 'Education Program Type 1', 'type': 'OTHER', 'description': 'The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.', 'armGroupLabels': ['Education Program Type 1']}, {'name': 'Education Program Type 2', 'type': 'OTHER', 'description': 'The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.', 'armGroupLabels': ['Education Program Type 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07052', 'city': 'West Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Kessler Foundation', 'geoPoint': {'lat': 40.79871, 'lon': -74.23904}}], 'overallOfficials': [{'name': 'Jeanne M Zanca, PhD, MPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kessler Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kessler Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Craig H. Neilsen Foundation', 'class': 'OTHER'}, {'name': 'Kessler Institute for Rehabilitation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}