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).
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
1 other identifier
interventional
52
1 country
1
Brief Summary
The study has three parts: Part 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. Part 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. Part 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2021
CompletedStudy Start
First participant enrolled
February 7, 2022
CompletedFirst Posted
Study publicly available on registry
March 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 8, 2025
April 1, 2025
3.8 years
December 20, 2021
April 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Cognitive-behavioural conceptualization of pain
\- measured with The Multidimensional Pain Inventory- Swedish (MPI-s)
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
Secondary Outcomes (7)
Self-reported Pain
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
Health Related Quality of Life
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
Self-efficacy
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
Pain catastrophizing
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
Health Related Quality of Life
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
- +2 more secondary outcomes
Study Arms (2)
Interdisciplinary team treatment + add on Intervention - Free Movement Dance
EXPERIMENTALInterdisciplinary team treatment + add on Intervention - Free Movement Dance as a physiotherapy intervention
Interdisciplinary team treatment + add on Modified person-centered progressive resistance exercise
ACTIVE COMPARATORInterdisciplinary team treatment + add on Control group - modified person-centered progressive resistance exercise as a physiotherapy intervention
Interventions
Free Movement Dance as a physiotherapy intervention
Modified person-centered progressive resistance exercise as a physiotherapy intervention
Eligibility Criteria
You may qualify if:
- 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.
- Age over 18 years and to be able to read and write Swedish. -
You may not qualify if:
- Red flag disorders such as malignancy/cancer, acute traumas such as fracture (less than six months ago) or infection.
- Pregnancy, severe mental illness, and ongoing substance abuse.
- Yellow flags as issues with compensation system or unsolved insurance issues with insurance company or the Swedish Social Insurance Agency. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Smärthjälpen
Gothenburg, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2021
First Posted
March 16, 2022
Study Start
February 7, 2022
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
April 8, 2025
Record last verified: 2025-04