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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Widespread Pain; Fibromyalgia
• Intervention / Treatment: Other: Free Movement Dance; Other: Modified person-centred progressive resistance exercise

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Smärthjälpen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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. -

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 after 12 months, which is standard procedure + after ending the add-on interventions and 24 months after the interdisciplinary treatments

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 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	- Physical function, Physical role and Quality of life measured by Rand - 36	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	measured by The General Self-Efficacy Scale (GSE)	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	measured by the Pain Catastrophizing Scale (PCS)	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	measured by the EuroQol-5 dimensions (EQ-5D-3L)	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
Anxiety and depression symptoms	measured by the Hospital Anxiety and Depression Scale (HADS)	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
Quality of sleep	measured by Insomnia Severity Scale (ISI)	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

Collaborators and Investigators

• Sponsor: Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain
• Other Study ID Numbers: EPM Dnr: 2021-04146

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No