Back to resultsEffects of and Exploring the Processes of Free Movement Dance as a Physiotherapy Intervention for Female Patients Diagnosed With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Free Movement Dance
Modified person-centred progressive resistance exercise
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
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. -
Sites / Locations
- SmärthjälpenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interdisciplinary team treatment + add on Intervention - Free Movement Dance
Interdisciplinary team treatment + add on Modified person-centered progressive resistance exercise
Arm Description
Interdisciplinary team treatment + add on Intervention - Free Movement Dance as a physiotherapy intervention
Interdisciplinary team treatment + add on Control group - modified person-centered progressive resistance exercise as a physiotherapy intervention
Outcomes
Primary Outcome Measures
Change in Cognitive-behavioural conceptualization of pain
- measured with The Multidimensional Pain Inventory- Swedish (MPI-s)
Secondary Outcome Measures
Self-reported Pain
measured by Numeric Pain Rating Scale (NPRS)
Health Related Quality of Life
- Physical function, Physical role and Quality of life measured by Rand - 36
Self-efficacy
measured by The General Self-Efficacy Scale (GSE)
Pain catastrophizing
measured by the Pain Catastrophizing Scale (PCS)
Health Related Quality of Life
measured by the EuroQol-5 dimensions (EQ-5D-3L)
Anxiety and depression symptoms
measured by the Hospital Anxiety and Depression Scale (HADS)
Quality of sleep
measured by Insomnia Severity Scale (ISI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05282758
Brief Title
Effects of and Exploring the Processes of Free Movement Dance as a Physiotherapy Intervention for Female Patients Diagnosed With Fibromyalgia
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interdisciplinary team treatment + add on Intervention - Free Movement Dance
Arm Type
Experimental
Arm Description
Interdisciplinary team treatment + add on Intervention - Free Movement Dance as a physiotherapy intervention
Arm Title
Interdisciplinary team treatment + add on Modified person-centered progressive resistance exercise
Arm Type
Active Comparator
Arm Description
Interdisciplinary team treatment + add on Control group - modified person-centered progressive resistance exercise as a physiotherapy intervention
Intervention Type
Other
Intervention Name(s)
Free Movement Dance
Intervention Description
Free Movement Dance as a physiotherapy intervention
Intervention Type
Other
Intervention Name(s)
Modified person-centred progressive resistance exercise
Intervention Description
Modified person-centered progressive resistance exercise as a physiotherapy intervention
Primary Outcome Measure Information:
Title
Change in Cognitive-behavioural conceptualization of pain
Description
- measured with The Multidimensional Pain Inventory- Swedish (MPI-s)
Time Frame
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 Measure Information:
Title
Self-reported Pain
Description
measured by Numeric Pain Rating Scale (NPRS)
Time Frame
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
Title
Health Related Quality of Life
Description
- Physical function, Physical role and Quality of life measured by Rand - 36
Time Frame
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
Title
Self-efficacy
Description
measured by The General Self-Efficacy Scale (GSE)
Time Frame
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
Title
Pain catastrophizing
Description
measured by the Pain Catastrophizing Scale (PCS)
Time Frame
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
Title
Health Related Quality of Life
Description
measured by the EuroQol-5 dimensions (EQ-5D-3L)
Time Frame
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
Title
Anxiety and depression symptoms
Description
measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame
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
Title
Quality of sleep
Description
measured by Insomnia Severity Scale (ISI)
Time Frame
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria EH Larsson, Associate professor
Phone
+46767905400
Email
maria.larsson@neuro.gu.se
Facility Information:
Facility Name
Smärthjälpen
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kicki Nordström, PhD stud
12. IPD Sharing Statement
Learn more about this trial
Effects of and Exploring the Processes of Free Movement Dance as a Physiotherapy Intervention for Female Patients Diagnosed With Fibromyalgia
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