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Clinical Trials/NCT05282758
NCT05282758
Active, not recruiting
Not Applicable

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

Göteborg University1 site in 1 country52 target enrollmentStarted: February 7, 2022Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Göteborg University
Enrollment
52
Locations
1
Primary Endpoint
Change in Cognitive-behavioural conceptualization of pain

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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. -

Outcomes

Primary Outcomes

Change in Cognitive-behavioural conceptualization of pain

Time Frame: 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

- measured with The Multidimensional Pain Inventory- Swedish (MPI-s)

Secondary Outcomes

  • 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)
  • 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)
  • 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)
  • 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)
  • Anxiety and depression symptoms(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(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)

Investigators

Sponsor
Göteborg University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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