Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-29 @ 10:56 PM
Study NCT ID:
NCT02482792
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2015-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Norwegian Psychomotor Physiotherapy in Patients With Long-lasting Musculoskeletal Pain.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-26', 'studyFirstSubmitDate': '2015-06-09', 'studyFirstSubmitQcDate': '2015-06-25', 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain', 'timeFrame': 'Change from baseline in pain at 3 months, at 6 months and 12 months.', 'description': 'Pain on the Numeric Pain Rating Scale (NPRS)'}], 'secondaryOutcomes': [{'measure': 'Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain', 'timeFrame': 'Change from baseline in wellbeing at 3 months, at 6 months and 12 months.', 'description': 'Wellbeing on the Short Form-12 Health Survey (SF-12)'}, {'measure': 'Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain', 'timeFrame': 'Change from baseline in sick-leave at 3 months, at 6 months and 12 months.', 'description': 'Sick-leave'}, {'measure': 'Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain', 'timeFrame': 'Change from baseline in shoulder function at 3 months, at 6 months and 12 months.', 'description': 'Function on the Shoulder Pain and Disability Inventory (SPADI)'}, {'measure': 'Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain', 'timeFrame': 'Change from baseline work related function at 3 months, at 6 months and 12 months.', 'description': 'Function on the Norwegian Functional Assessment Scale (NFAS)'}, {'measure': 'Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain', 'timeFrame': 'Change from baseline neck function at 3 months, at 6 months and 12 months.', 'description': 'Neck Disability Index (NDI)'}, {'measure': 'Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain', 'timeFrame': 'Change from baseline flexibility at 6 months.', 'description': 'Global Body Examination-Flexibility (GBE)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Musculoskeletal disorders', 'Psychosomatic', 'Pain'], 'conditions': ['Physical Disability']}, 'referencesModule': {'references': [{'pmid': '27496046', 'type': 'DERIVED', 'citation': 'Dragesund T, Kvale A. Study protocol for Norwegian Psychomotor Physiotherapy versus Cognitive Patient Education in combination with active individualized physiotherapy in patients with long-lasting musculoskeletal pain - a randomized controlled trial. BMC Musculoskelet Disord. 2016 Aug 5;17:325. doi: 10.1186/s12891-016-1159-8.'}]}, 'descriptionModule': {'briefSummary': 'The aim is to examine the effect of Norwegian Psychomotor Physiotherapy (NPMP) in employees with long-lasting musculoskeletal pain compared to employees receiving Cognitive Patient Education in combination with active individual physiotherapy (COPE-PT) on pain, function, quality of life and sick-leave', 'detailedDescription': 'The NPMP is based on the assumption that patients with long-lasting problems, physical and/or psychological, may react with general aberrations related to posture, respiration, and movements, as well as with muscular tension and skin changes.\n\nEmployees With Long lasting musculoskeletal pain problems, working in the Municipality of Bergen, will be invited to participate in an Randomized Clinical Trial (RCT), and randomized to either receive Norwegian Psychomotor Physiotherapy (NPMP) or a series of Cognitive Patient Education in combination with active individual physiotherapy (COPE-PT). The aim is to examine the effect of NPMP compared to those receiving COPE-PT on pain, function, quality of life and sick-leave.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients With neck,shoulder and/or widespread pain\n* Pain (≥ 3 Numeric Pain Rating Scale (NPRS)\n* Functional problems measured with Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ), Neck Disability Index (NDI) and/or Shoulder Pain and Disability Inventory (SPADI)-been sick-listed for 4-8 weeks, or on the brink of becoming sick-listed, or having had residual neck- and shoulder complaints problems during the last two years with several short-term sick-leaves.\n* =/6 American College of Rheumatology (ACR) tender points,\n* Reduced Relaxation and Flexibility from the Global Physiotherapy Examination (GPE)\n\nExclusion Criteria:\n\n* Sick-listed \\> 6 months'}, 'identificationModule': {'nctId': 'NCT02482792', 'acronym': 'NPMP', 'briefTitle': 'Norwegian Psychomotor Physiotherapy in Patients With Long-lasting Musculoskeletal Pain.', 'organization': {'class': 'OTHER', 'fullName': 'University of Bergen'}, 'officialTitle': 'Norwegian Psychomotor Physiotherapy Versus Cognitive Patient Education and Active Physiotherapy', 'orgStudyIdInfo': {'id': 'd7k8fj2m'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Norwegian Psychomotor Physiotherapy', 'description': 'NPMP is a body-mind awareness approach, often given in a combination of massage, exercises and conversations. The NPMP is individualized, with duration of 45-60 minutes in each session. As the NPMP is a longitudinal and normally slow process to obtain change, treatment can last up till one year, in the beginning once a week, and after some time once a month.', 'interventionNames': ['Other: Norwegian Psychomotor Physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Patient Education and PT', 'description': 'The comparison group will receive a combination of education about how to manage pain (COPE) followed by active individual physiotherapy.They will receive one session weekly with COPE, given by a physiotherapist, maximum 4 times, followed by active individual Physiotherapy (PT).', 'interventionNames': ['Other: Cognitive Patient Education and PT']}], 'interventions': [{'name': 'Norwegian Psychomotor Physiotherapy', 'type': 'OTHER', 'otherNames': ['NPMP'], 'description': 'The recruited patients will after randomization receive either Norwegian Psychomotor Physiotherapy (NPMP) or COPE combined with active individual physiotherapy. In NPMP the treatment is individualized, targeting body-mind awareness through exercise, massage and therapeutic conversation', 'armGroupLabels': ['Norwegian Psychomotor Physiotherapy']}, {'name': 'Cognitive Patient Education and PT', 'type': 'OTHER', 'otherNames': ['COPE- PT'], 'description': 'The comparison group will receive a combination of education about how to manage pain (COPE) followed by active individual physiotherapy.', 'armGroupLabels': ['Cognitive Patient Education and PT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5018', 'city': 'Bergen', 'state': 'Hordaland', 'country': 'Norway', 'facility': 'Department of Global Public Health and Primary Care, UiB', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Alice Kvåle, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bergen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tove Dragesund', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Fund for Postgraduate Training in Physiotherapy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Post doc', 'investigatorFullName': 'Tove Dragesund', 'investigatorAffiliation': 'University of Bergen'}}}}