Effects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP)

Not Applicable

Completed

• Conditions: Chronic Widespread Pain
• Interventions: Behavioral: Physical exercise and online support; Behavioral: Physical exercise

• Registration Number: NCT03434899
• Lead Sponsor: Göteborg University

Brief Summary

The aim is to evaluate a novel treatment routine where contact through a smart phone/computer is used for online support for patients suffering from chronic widespread pain (CWP). The outline is that patients are encouraged to perform physical activity during a period of 12 months with online support from a physical therapist.

Detailed Description

The intervention follows principles from the theories of person-centered care and self-efficacy. The examinations performed at baseline and after six months were conducted by blinded examiners at a visit at the primary health care centers. All participants developed a person-centered health plan for physical activity together with a physiotherapist. The intervention group was supported with a digital platform for six months.

Study Timeline

• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-14
• Study Start: 2018-02-15
• Study First Posted: 2018-02-15
• Primary Completion: 2019-04-01
• Study Completion: 2020-04-16
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• fulfilling the American Colleague of Rheumatology (ACR) 1990 criteria for chronic widespread pain (CWP)
• access to a smart phone or computer

Exclusion Criteria

• other serious diseases that cause pain or hinder exercise, such as heart disease, neurological disease or severe osteoarthritis
• unable to speak or read Swedish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Physical exercise and online support	Health care plan including physical exercise and online support during the entire study
Control Group	Physical exercise	Health care plan including physical exercise

Primary Outcome Measures

Name	Time	Method
Pain during the last week	Change from Baseline Pain at 6 months	The Fibromyalgia Impact Questionnaire (FIQ) subscale for pain.

Secondary Outcome Measures

Name	Time	Method
Fatigue	Change from Baseline Fatigue at 6 months	The Multidimensional Fatigue Inventory (MFI-20), comprising several subscale, of which the Physical Fatigue subscale is of interest for this study.
Health	Change from Baseline Health at 6 months	The Fibromyalgia Impact Questionnaire (FIQ) total score. The FIQ comprises 10 subscales and the total score is the mean value of them.

Trial Locations

Locations (3)

Alingsas Primary Health Care; 🇸🇪 Alingsas, Sweden

Göteborg Primary Health Care; 🇸🇪 Göteborg, Sweden

Uddevalla Primary Health Care; 🇸🇪 Uddevalla, Sweden