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Completed

NCT Number: NCT03434899

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

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.

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Key information

Conditions

Chronic Widespread Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alingsas Primary Health Care, Alingsås, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Physical exercise and online support

Behavioral

Person-centered design of a health care plan including individually adjusted physical exercise. Online support for management of health care plan.

Physical exercise

Behavioral

Person-centered design of health care plan individually adjusted physical exercise.

Primary outcomes

  1. Pain during the last week

    Time frame: Change from Baseline Pain at 6 months

    The Fibromyalgia Impact Questionnaire (FIQ) subscale for pain.

Secondary outcomes

  1. Fatigue

    Time frame: 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.

  2. Health

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Sahlgrenska University Hospital
  • Vastra Gotaland Region

Registry information

Acronym: GAU-E

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 15, 2018
Registry last updated
Oct 8, 2020

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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