Effects of and Exploring the Processes of Free Movement Dance as a Physiotherapy Intervention for Female Patients Diagnosed With Fibromyalgia

Study Overview
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Brief Summary
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The study has two parts: Part 1: To evaluate, for adult female patients diagnosed with 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 develop a theoretically informed understanding of the processes of Free Movement Dance as an add-on intervention after interdisciplinary pain management/rehabilitation at a specialist pain clinic for adult female patients diagnosed with fibromyalgia.

Official Title
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Part 1. Effects of Free Movement Dance as a Physiotherapy Intervention for Female Patients Diagnosed With Fibromyalgia - Prospective Randomised Controlled Study With Open Design and Blinded Endpoints. Part 2. Exploring the Processes of Free Movement Dance as a Physiotherapy Intervention for Female Patients Diagnosed With Fibromyalgia Over Time - a Qualitative Study.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Free Movement Dance
* Other: Modified person-centred progressive resistance exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients diagnosed with 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. - Exclusion Criteria: 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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interdisciplinary team treatment + add on Intervention - Free Movement Dance<br>Interdisciplinary team treatment + add on Intervention - Free Movement Dance as a physiotherapy intervention | Other: Free Movement Dance<br>* Free Movement Dance as a physiotherapy intervention<br>|
| Active Comparator: Interdisciplinary team treatment + add on Modified person-centered progressive resistance exercise<br>Interdisciplinary team treatment + add on Control group - modified person-centered progressive resistance exercise as a physiotherapy intervention | Other: Modified person-centred progressive resistance exercise<br>* Modified person-centered progressive resistance exercise as a physiotherapy intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 twelve months after finishing the interdisciplinary treatments as standard procedure + after ending the add-on interventions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Pain | measured by Numeric Pain Rating Scale (NPRS) | Before and after the three months of interdisciplinary specialist interventions, and twelve months after finishing the interdisciplinary treatments as standard procedure + after ending the add-on interventions | 
| Health Related Quality of Life | - Physical function, Physical role and Quality of life measured by Rand - 36 | Before and after the three months of interdisciplinary specialist interventions, and twelve months after finishing the interdisciplinary treatments as standard procedure + after ending the add-on interventions | 
| Self-efficacy | measured by The General Self-Efficacy Scale (GSE) | Before and after the three months of interdisciplinary specialist interventions, and twelve months after finishing the interdisciplinary treatments as standard procedure + after ending the add-on interventions | 
| Pain catastrophizing | measured by the Pain Catastrophizing Scale (PCS) | Before and after the three months of interdisciplinary specialist interventions, and twelve months after finishing the interdisciplinary treatments as standard procedure + after ending the add-on interventions | 
| Health Related Quality of Life | measured by the EuroQol-5 dimensions (EQ-5D-3L) | Before and after the three months of interdisciplinary specialist interventions, and twelve months after finishing the interdisciplinary treatments as standard procedure + after ending the add-on interventions | 
| Anxiety and depression symptoms | measured by the Hospital Anxiety and Depression Scale (HADS) | Before and after the three months of interdisciplinary specialist interventions, and twelve months after finishing the interdisciplinary treatments as standard procedure + after ending the add-on interventions | 
| Quality of sleep | measured by Insomnia Severity Scale (ISI) | Before and after the three months of interdisciplinary specialist interventions, and twelve months after finishing the interdisciplinary treatments as standard procedure + after ending the add-on interventions |