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).

Fibromyalgia Clinical Trial

Official title:

Part 1. Effects of Free Movement Dance as a Physiotherapy Intervention for Female Patients Diagnosed With Chronic Widespread Pain Including (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 Chronic Widespread Pain (Including Fibromyalgia) Over Time - a Qualitative Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282758
• Other study ID #: EPM Dnr: 2021-04146
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Göteborg University
• Contact: Maria EH Larsson, Associate professor
• Phone: +46767905400
• Email: maria.larsson[@]neuro.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study has two 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 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 chronic widespread pain (including fibromyalgia).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Widespread Pain
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Free Movement Dance
Free Movement Dance as a physiotherapy intervention
• Modified person-centred progressive resistance exercise
Modified person-centered progressive resistance exercise as a physiotherapy intervention

Locations

Country	Name	City	State
Sweden	Smärthjälpen	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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