Clinical trial 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).
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 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Chronic Widespread Pain
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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. -

Primary outcomes:
measure: Change in Cognitive-behavioural conceptualization of pain
timeFrame: 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:
measure: Self-reported Pain
timeFrame: 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
measure: Health Related Quality of Life
timeFrame: 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
measure: Self-efficacy
timeFrame: 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
measure: Pain catastrophizing
timeFrame: 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
measure: Health Related Quality of Life
timeFrame: 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
measure: Anxiety and depression symptoms
timeFrame: 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
measure: Quality of sleep
timeFrame: 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
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Smärthjälpen
Study officials:
References: