FibromyalgiaNCT02872129
12-years Follow-up on 166 Female Patients With Fibromyalgia or Chronic Widespread Pain
An observational study of Fibromyalgia and Chronic Widespread Pain, run by Göteborg University at 3 sites in Sweden.
Trial summary
A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP) in western Sweden. The 166 women participated in a Randomised Controlled Trial called GAU in 2004-2005, aiming to investigate the effect of pool exercise and patient education. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fibromyalgia, Chronic Widespread Pain
- How many people
- 126 participants
- Where
- 3 sitesSweden
- Study dates
- May 2016to Dec 2016
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 166 women who 2004/2005 participated in the study GAU.
Who may be able to join
- All 166 patients who participated in the study GAU in 2004/2005. (The inclusion criteria of GAU was women with FM or CWP, 18-60 years old. Patients with widespread pain; pain in the right and left side of the body, above and below the waist, as well as axial pain, for at least three months were classified as chronic widespread pain (CWP). Patients who fulfilled the criteria for CWP and who also had pain at palpation of at least 11 of 18 pre-defined tender points were classified as fibromyalgia (FM).
- Exclusion criteria for GAU was serious physical or psychological disease)
Who cannot join
- Patients who has developed serious physical or psychological disease since participating in the GAU 2004/2005
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Närhälsan, Region Västra Götaland
Alingsås
Närhälsan, Region Västra Götaland
Gothenburg
Närhälsan, Region Västra Götaland
Uddevalla
About this study
A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP) in western Sweden.
The 166 women participated in a Randomised Controlled Trial called GAU in 2004-2005, aiming to investigate the effect of pool exercise and patient education.
Read more
The primary aim of the present study is to examine the change of symptoms after 11-12 years in 166 women with FM or CWP and also investigate predictors of change of symptoms and work ability.
The 166 women will be asked to participate in the present follow-up study. The follow-up examination comprises a standardised interview of symptoms and demographic variables, a battery of self-administered questionnaires and tests of physical function.
Read the detailed description
A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP).
The 166 women participated in a Randomised Controlled Trial called GAU 2004-2005 in three cities in western Sweden; Göteborg, Alingsås and Uddevalla. The RCT aimed to investigate the effect of pool exercise and patient education.
The primary aim of the present study is to examine the change of symptoms after 11-12 years in 166 women with FM or CWP and also investigate predictors of change of symptoms and work ability.
The 166 women will be contacted by mail and telephone, and asked to participate in the present follow-up study.
The follow-up examination comprises a standardised interview of symptoms and demographic variables, a battery of self-administered questionnaires and tests of physical function.
- Conditions
- Fibromyalgia, Chronic Widespread Pain
- Keywords
- Fibromyalgia, chronic widespread pain, follow-up, pain, fatigue, symptoms, workability, physical function
- Medical subject headings
- Fibromyalgia, Chronic Pain, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 166 women with FM/CWP | 166 women with Fibromyalgia (FM) or Chronic Widespread Pain (CWP) that participated in an Randomised Controlled Trial called GAU in western Sweden 2004-2005. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
pain intensity assessed with the Fibromyalgia Impact questionnaire subscale for pain
Measured: 2016 (to be compared with previous examination performed in 2004/2005)
distribution of pain
Distribution of pain
Measured: 2016 (to be compared with previous examination performed in 2004/2005)
Secondary outcomes (9)
Fatigue
fatigue assessed with the Multidimensional fatigue inventory (MFI-20)
Measured: 2016 (to be compared with previous examination performed in 2004/2005)
Fatigue
fatigue assessed with the Fibromyalgia Impact Questionnaire subscale for global fatigue
Measured: 2016 (to be compared with previous examination performed in 2004/2005)
workability
workability assessed as percentage of full time in work
Measured: 2016 (to be compared with previous examination performed in 2004/2005)
Walking capacity
Walking capacity assessed with 6 min walk test
Measured: 2016 (to be compared with previous examination performed in 2004/2005)
Physical function in lower limbs
physical function in lower limbs assessed with chair-test
Measured: 2016 (to be compared with previous examination performed in 2004/2005)
Hand grip force
Hand grip force assessed with the Grippit
Measured: 2016 (to be compared with previous examination performed in 2004/2005)
Physical activity
physical activity in leisure time assessed with the Leisure Time Physical Activity Instrument
Measured: 2016 (to be compared with previous examination performed in 2004/2005)
Depression and anxiety
depression and anxiety assessed with the Hospital Anxiety and Depression Scale
Measured: 2016 (to be compared with previous examination performed in 2004/2005)
Health related quality of life
Health related quality of life assessed with the Short-Form 36
Measured: 2016 (to be compared with previous examination performed in 2004/2005)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Anna Bergenheim, PhD, Study director, University of Gothenburg, Sahlgrenska Academy, Institution of Neuroscience and Physiology - Section of Health and Rehabilitation, Physiotherapy, Göteborg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872129
- Sponsor's protocol ID
- GAU1-U
- Status last verified
- May 2019
- First submitted
- 30 Jun 2016
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bergenheim A, Juhlin S, Nordeman L, Joelsson M, Mannerkorpi K. Stress levels predict substantial improvement in pain intensity after 10 to 12 years in women with fibromyalgia and chronic widespread pain: a cohort study. BMC Rheumatol. 2019 Jun 24;3:5. doi: 10.1186/s41927-019-0072-9. eCollection 2019.
PubMed 31286111
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-years Follow-up on 166 Female Patients With Fibromyalgia or Chronic Widespread Pain
- ClinicalTrials.gov ID
- NCT02872129
- Acronym / sponsor ID
- GAU1-U
- Conditions
- Fibromyalgia, Chronic Widespread Pain
- Keywords
- Fibromyalgia, chronic widespread pain, follow-up, pain, fatigue, symptoms, workability, physical function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- May 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Aug 2016 (estimated)
- 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.
A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP) in western Sweden.
The 166 women participated in a Randomised Controlled Trial called GAU in 2004-2005, aiming to investigate the effect of pool exercise and patient education.
The primary aim of the present study is to examine the change of symptoms after 11-12 years in 166 women with FM or CWP and also investigate predictors of change of symptoms and work ability.
The 166 women will be asked to participate in the present follow-up study. The follow-up examination comprises a standardised interview of symptoms and demographic variables, a battery of self-administered questionnaires and tests of physical function.
Detailed description
A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP).
The 166 women participated in a Randomised Controlled Trial called GAU 2004-2005 in three cities in western Sweden; Göteborg, Alingsås and Uddevalla. The RCT aimed to investigate the effect of pool exercise and patient education.
The primary aim of the present study is to examine the change of symptoms after 11-12 years in 166 women with FM or CWP and also investigate predictors of change of symptoms and work ability.
The 166 women will be contacted by mail and telephone, and asked to participate in the present follow-up study.
The follow-up examination comprises a standardised interview of symptoms and demographic variables, a battery of self-administered questionnaires and tests of physical function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 166 women with FM/CWP | – | –166 women with Fibromyalgia (FM) or Chronic Widespread Pain (CWP) that participated in an Randomised Controlled Trial called GAU in western Sweden 2004-2005. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 166 women who 2004/2005 participated in the study GAU.
Key inclusion criteria (2 listed)
- All 166 patients who participated in the study GAU in 2004/2005. (The inclusion criteria of GAU was women with FM or CWP, 18-60 years old. Patients with widespread pain; pain in the right and left side of the body, above and below the waist, as well as axial pain, for at least three months were classified as chronic widespread pain (CWP). Patients who fulfilled the criteria for CWP and who also had pain at palpation of at least 11 of 18 pre-defined tender points were classified as fibromyalgia (FM).
- Exclusion criteria for GAU was serious physical or psychological disease)
Key exclusion criteria (1 listed)
- Patients who has developed serious physical or psychological disease since participating in the GAU 2004/2005
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pain intensity
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
pain intensity assessed with the Fibromyalgia Impact questionnaire subscale for pain
distribution of pain
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
Distribution of pain
9 secondary outcomes
Fatigue
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
Fatigue
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
workability
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
Walking capacity
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
Physical function in lower limbs
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
Hand grip force
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
Physical activity
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
Depression and anxiety
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
Health related quality of life
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
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 29 May 2019.
- Derived from this study: PubMed 31286111Bergenheim A, Juhlin S, Nordeman L, Joelsson M, Mannerkorpi K. Stress levels predict substantial improvement in pain intensity after 10 to 12 years in women with fibromyalgia and chronic widespread pain: a cohort study. BMC Rheumatol. 2019 Jun 24;3:5. doi: 10.1186/s41927-019-0072-9. eCollection 2019.
- 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.
Anna Bergenheim, PhD study director
University of Gothenburg, Sahlgrenska Academy, Institution of Neuroscience and Physiology - Section of Health and Rehabilitation, Physiotherapy, Göteborg, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and 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 1 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 29 May 2019. 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 intensity (time frame: 2016 (to be compared with previous examination performed in 2004/2005)). The study lists 2 primary outcomes in all. 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 NCT02872129, which also lists 1 linked publication.
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 29 May 2019.