Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-02 @ 4:29 AM
Study NCT ID:
NCT05282758
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-08
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of and Exploring the Processes of Free Movement Dance as a Physical Therapy Intervention for Female Patients Diagnosed With Chronic Widespread Pain (Including Fibromyalgia).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cognitive-behavioural conceptualization of pain', 'timeFrame': 'Before and after the three months of interdisciplinary specialist interventions and after 12 months, which is standard procedure + after ending the add-on interventions and 24 months after the interdisciplinary treatments', 'description': '\\- measured with The Multidimensional Pain Inventory- Swedish (MPI-s)'}], 'secondaryOutcomes': [{'measure': 'Self-reported Pain', 'timeFrame': 'Before and after the three months of interdisciplinary specialist interventions and after 12 months, which is standard procedure + after ending the add-on interventions and 24 months after the interdisciplinary treatments', 'description': 'measured by Numeric Pain Rating Scale (NPRS)'}, {'measure': 'Health Related Quality of Life', 'timeFrame': 'Before and after the three months of interdisciplinary specialist interventions and after 12 months, which is standard procedure + after ending the add-on interventions and 24 months after the interdisciplinary treatments', 'description': '\\- Physical function, Physical role and Quality of life measured by Rand - 36'}, {'measure': 'Self-efficacy', 'timeFrame': 'Before and after the three months of interdisciplinary specialist interventions and after 12 months, which is standard procedure + after ending the add-on interventions and 24 months after the interdisciplinary treatments', 'description': 'measured by The General Self-Efficacy Scale (GSE)'}, {'measure': 'Pain catastrophizing', 'timeFrame': 'Before and after the three months of interdisciplinary specialist interventions and after 12 months, which is standard procedure + after ending the add-on interventions and 24 months after the interdisciplinary treatments', 'description': 'measured by the Pain Catastrophizing Scale (PCS)'}, {'measure': 'Health Related Quality of Life', 'timeFrame': 'Before and after the three months of interdisciplinary specialist interventions and after 12 months, which is standard procedure + after ending the add-on interventions and 24 months after the interdisciplinary treatments', 'description': 'measured by the EuroQol-5 dimensions (EQ-5D-3L)'}, {'measure': 'Anxiety and depression symptoms', 'timeFrame': 'Before and after the three months of interdisciplinary specialist interventions and after 12 months, which is standard procedure + after ending the add-on interventions and 24 months after the interdisciplinary treatments', 'description': 'measured by the Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Quality of sleep', 'timeFrame': 'Before and after the three months of interdisciplinary specialist interventions and after 12 months, which is standard procedure + after ending the add-on interventions and 24 months after the interdisciplinary treatments', 'description': 'measured by Insomnia Severity Scale (ISI)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibromyalgia', 'Chronic Widespread Pain']}, 'descriptionModule': {'briefSummary': "The study has three parts:\n\nPart 1: To evaluate, for adult female patients diagnosed with chronic widespread pain (including fibromyalgia), the effects of Free Movement Dance as an add-on intervention after interdisciplinary pain management/rehabilitation at a specialist pain clinic versus modified person-centered progressive resistance exercise. The cognitive-behavioural conceptualization of pain, effects on pain intensity, physical function, self-efficacy, pain catastrophizing, health related quality of life, anxiety and depression symptoms and quality of sleep will be evaluated.\n\nPart 2: To explore, for adult female patients diagnosed with chronic widespread pain (including fibromyalgia), the processes of Free Movement Dance, as an add-on intervention after interdisciplinary pain management/rehabilitation at a specialist pain clinic, to generate a substantive theory useful for clinical praxis.\n\nPart 3: To explore and describe why participants who agreed and signed consent choose to withdraw from participating in the interventions of the study's part 1."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female Patients Diagnosed With Chronic Widespread Pain (Including Fibromyalgia) participating in an interdisciplinary pain management and rehabilitation for three months on a specialist pain clinic in south-west of Sweden.\n* Age over 18 years and to be able to read and write Swedish. -\n\nExclusion Criteria:\n\n* Red flag disorders such as malignancy/cancer, acute traumas such as fracture (less than six months ago) or infection.\n* Pregnancy, severe mental illness, and ongoing substance abuse.\n* Yellow flags as issues with compensation system or unsolved insurance issues with insurance company or the Swedish Social Insurance Agency. -'}, 'identificationModule': {'nctId': 'NCT05282758', 'briefTitle': 'Effects of and Exploring the Processes of Free Movement Dance as a Physical Therapy Intervention for Female Patients Diagnosed With Chronic Widespread Pain (Including Fibromyalgia).', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Part 1. Effects of Free Movement Dance as a Physiotherapy Intervention for Female Patients Diagnosed With Chronic Widespread Pain Including (Fibromyalgia) - Prospective Randomised Controlled Trial. Part 2. Exploring the Processes of Free Movement Dance as a Physiotherapy Intervention for Female Patients Diagnosed With Chronic Widespread Pain (Including Fibromyalgia) Over Time - a Qualitative Study. Part 3. Exploring Withdrawal From Study Participation - a Qualitative Study', 'orgStudyIdInfo': {'id': 'EPM Dnr: 2021-04146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interdisciplinary team treatment + add on Intervention - Free Movement Dance', 'description': 'Interdisciplinary team treatment + add on Intervention - Free Movement Dance as a physiotherapy intervention', 'interventionNames': ['Other: Free Movement Dance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interdisciplinary team treatment + add on Modified person-centered progressive resistance exercise', 'description': 'Interdisciplinary team treatment + add on Control group - modified person-centered progressive resistance exercise as a physiotherapy intervention', 'interventionNames': ['Other: Modified person-centred progressive resistance exercise']}], 'interventions': [{'name': 'Free Movement Dance', 'type': 'OTHER', 'description': 'Free Movement Dance as a physiotherapy intervention', 'armGroupLabels': ['Interdisciplinary team treatment + add on Intervention - Free Movement Dance']}, {'name': 'Modified person-centred progressive resistance exercise', 'type': 'OTHER', 'description': 'Modified person-centered progressive resistance exercise as a physiotherapy intervention', 'armGroupLabels': ['Interdisciplinary team treatment + add on Modified person-centered progressive resistance exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Smärthjälpen', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}