NCT05282758

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

3.8 years

First QC Date

December 20, 2021

Last Update Submit

April 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Interdisciplinary team treatment + add on Intervention - Free Movement Dance

EXPERIMENTAL

Interdisciplinary team treatment + add on Intervention - Free Movement Dance as a physiotherapy intervention

Other: Free Movement Dance

Interdisciplinary team treatment + add on Modified person-centered progressive resistance exercise

ACTIVE COMPARATOR

Interdisciplinary team treatment + add on Control group - modified person-centered progressive resistance exercise as a physiotherapy intervention

Other: Modified person-centred progressive resistance exercise

Interventions

Free Movement Dance as a physiotherapy intervention

Interdisciplinary team treatment + add on Intervention - Free Movement Dance

Modified person-centered progressive resistance exercise as a physiotherapy intervention

Interdisciplinary team treatment + add on Modified person-centered progressive resistance exercise

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Smärthjälpen

Gothenburg, Sweden

Location

MeSH Terms

Conditions

FibromyalgiaChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2021

First Posted

March 16, 2022

Study Start

February 7, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 8, 2025

Record last verified: 2025-04

Locations