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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03434899
Other study ID # FOU VGR 237261
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2018
Est. completion date April 16, 2020

Study information

Verified date October 2020
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date April 16, 2020
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 62 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical exercise and online support
Person-centered design of a health care plan including individually adjusted physical exercise. Online support for management of health care plan.
Physical exercise
Person-centered design of health care plan individually adjusted physical exercise.

Locations

Country Name City State
Sweden Alingsas Primary Health Care Alingsas
Sweden Göteborg Primary Health Care Göteborg
Sweden Uddevalla Primary Health Care Uddevalla

Sponsors (3)

Lead Sponsor Collaborator
Göteborg University Sahlgrenska University Hospital, Sweden, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain during the last week The Fibromyalgia Impact Questionnaire (FIQ) subscale for pain. Change from Baseline Pain at 6 months
Secondary Fatigue The Multidimensional Fatigue Inventory (MFI-20), comprising several subscale, of which the Physical Fatigue subscale is of interest for this study. Change from Baseline Fatigue at 6 months
Secondary Health The Fibromyalgia Impact Questionnaire (FIQ) total score. The FIQ comprises 10 subscales and the total score is the mean value of them. Change from Baseline Health at 6 months
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