Chronic Widespread PainGAU-ENCT03434899
Effects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP)
A study testing Physical exercise and online support and Physical exercise in people with Chronic Widespread Pain, run by Göteborg University at 3 sites in Sweden.
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). Read more about this study
- Who is it for?
- Ages 20 to 62 years
- Conditions the study is for
- Chronic Widespread Pain
- What is being tested?
- Physical exercise and online support and Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 3 sitesSweden
- Study dates
- 15 Feb 2018to 16 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- fulfilling the American Colleague of Rheumatology (ACR) 1990 criteria for chronic widespread pain (CWP)
- access to a smart phone or computer
Who cannot join
- other serious diseases that cause pain or hinder exercise, such as heart disease, neurological disease or severe osteoarthritis
- unable to speak or read Swedish
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Alingsas Primary Health Care
Alingsås
Göteborg Primary Health Care
Gothenburg
Uddevalla Primary Health Care
Uddevalla
About this study
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.
Read the 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.
- Conditions
- Chronic Widespread Pain
- Being tested
- Physical exercise and online support, Physical exercise
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise and online supportBehavioural
Person-centered design of a health care plan including individually adjusted physical exercise. Online support for management of health care plan.
Physical exerciseBehavioural
Person-centered design of health care plan individually adjusted physical exercise.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Health care plan including physical exercise and online support during the entire study Receives: Behavioral: Physical exercise and online support |
| Control Group | Active comparator | Health care plan including physical exercise Receives: Behavioral: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during the last week
The Fibromyalgia Impact Questionnaire (FIQ) subscale for pain.
Measured: Change from Baseline Pain at 6 months
Secondary outcomes (2)
Fatigue
The Multidimensional Fatigue Inventory (MFI-20), comprising several subscale, of which the Physical Fatigue subscale is of interest for this study.
Measured: Change from Baseline Fatigue at 6 months
Health
The Fibromyalgia Impact Questionnaire (FIQ) total score. The FIQ comprises 10 subscales and the total score is the mean value of them.
Measured: Change from Baseline Health at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start15 Feb 2018
- Primary completion1 Apr 2019
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Widespread PainStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Kaisa Mannerkorpi, PhD, Principal investigator, Sahlgren University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434899
- Sponsor's protocol ID
- FOU VGR 237261
- Acronym
- GAU-E
- Status last verified
- Oct 2020
- First submitted
- 6 Feb 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Juhlin S, Mannerkorpi K, Larsson A, Bergenheim A. Factors predicting health-enhancing physical activity in patients with chronic widespread pain following a person-centred health plan. Ann Med. 2026 Dec;58(1):2678668. doi: 10.1080/07853890.2026.2678668. Epub 2026 May 26.
PubMed 42189849Feldthusen C, Bergenheim A, Barenfeld E, Gjertsson I, Larsson A, Mannerkorpi K. Experience of co-creation of a health plan and support for sustainable physical activity among people with chronic widespread pain: a qualitative interview study in Sweden. BMJ Open. 2022 Apr 8;12(4):e059432. doi: 10.1136/bmjopen-2021-059432.
PubMed 35396312
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP)
- ClinicalTrials.gov ID
- NCT03434899
- Acronym / sponsor ID
- GAU-E / FOU VGR 237261
- Conditions
- Chronic Widespread Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Vastra Gotaland Region
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Physical exercise and online supportHealth care plan including physical exercise and online support during the entire study |
| Control Group | Active comparator | Behavioral: Physical exerciseHealth care plan including physical exercise |
Who may qualify
- Ages
- 20 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- fulfilling the American Colleague of Rheumatology (ACR) 1990 criteria for chronic widespread pain (CWP)
- access to a smart phone or computer
Key exclusion criteria (2 listed)
- other serious diseases that cause pain or hinder exercise, such as heart disease, neurological disease or severe osteoarthritis
- unable to speak or read Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise and online supportPerson-centered design of a health care plan including individually adjusted physical exercise. Online support for management of health care plan. | Behavioural | Intervention group |
| Physical exercisePerson-centered design of health care plan individually adjusted physical exercise. | Behavioural | Control Group |
Primary outcome
Pain during the last week
Time frame: Change from Baseline Pain at 6 months
The Fibromyalgia Impact Questionnaire (FIQ) subscale for pain.
2 secondary outcomes
Fatigue
Time frame: Change from Baseline Fatigue at 6 months
Health
Time frame: Change from Baseline Health at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 42189849Juhlin S, Mannerkorpi K, Larsson A, Bergenheim A. Factors predicting health-enhancing physical activity in patients with chronic widespread pain following a person-centred health plan. Ann Med. 2026 Dec;58(1):2678668. doi: 10.1080/07853890.2026.2678668. Epub 2026 May 26.
- Derived from this study: PubMed 35396312Feldthusen C, Bergenheim A, Barenfeld E, Gjertsson I, Larsson A, Mannerkorpi K. Experience of co-creation of a health plan and support for sustainable physical activity among people with chronic widespread pain: a qualitative interview study in Sweden. BMJ Open. 2022 Apr 8;12(4):e059432. doi: 10.1136/bmjopen-2021-059432.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaisa Mannerkorpi, PhD principal investigator
Sahlgren University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise and online support and Physical exercise in people with Chronic Widespread Pain, run by Göteborg University at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during the last week (time frame: Change from Baseline Pain at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03434899, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.