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NCT Number: NCT05282758

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).

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Fibromyalgia Chronic Pain Chronic Widespread Pain Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Smärthjälpen

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Free Movement Dance

Other

Free Movement Dance as a physiotherapy intervention

Modified person-centred progressive resistance exercise

Other

Modified person-centered progressive resistance exercise as a physiotherapy intervention

Primary outcomes

  1. 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

  1. Self-reported 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 by Numeric Pain Rating Scale (NPRS)

  2. Health Related Quality of Life

    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

    • Physical function, Physical role and Quality of life measured by Rand - 36

  3. Self-efficacy

    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 by The General Self-Efficacy Scale (GSE)

  4. Pain catastrophizing

    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 by the Pain Catastrophizing Scale (PCS)

  5. Health Related Quality of Life

    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 by the EuroQol-5 dimensions (EQ-5D-3L)

  6. Anxiety and depression symptoms

    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 by the Hospital Anxiety and Depression Scale (HADS)

  7. Quality of sleep

    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 by Insomnia Severity Scale (ISI)

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study 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 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2022
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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