FibromyalgiaNCT03319355
Multicomponent Therapy for Fibromyalgia
A study testing cognitive behavioral therapy in people with Fibromyalgia, run by University Ghent.
Trial summary
Therapy for fibromyalgia is a well discussed topic in literature, yet not thoroughly evidence-based. Several unicomponent therapies seem to be benificial. Whereas multicomponent and multidisciplinary therapy gains importance and revealing promising results, the investigators aim to combine two well-known therapies in… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jan 2013
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- woman with fibromyalgia
- between the age of 20 and 50
- agreement with therapy protocol
Who cannot join
- high indication of depression measured with the Beck Depression Index
About this study
Official title: The Effect of a 12-week Multicomponent Therapy in Fibromyalgia
Therapy for fibromyalgia is a well discussed topic in literature, yet not thoroughly evidence-based. Several unicomponent therapies seem to be benificial. Whereas multicomponent and multidisciplinary therapy gains importance and revealing promising results, the investigators aim to combine two well-known therapies in a program for patients with fibromyalgia.
From clinical experience, a high drop-out rate has been stated. All data will be explored to analyse explanatory factors.
- Conditions
- Fibromyalgia
- Being tested
- cognitive behavioral therapy
- Keywords
- multicomponent therapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
Also called physical therapy
exercise therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire
impact of fibromyalgia on daily life with a questionnaire
Measured: 6weeks
Tampa scale for kinesiophobia
rating the kinesiophobia with a questionnaire
Measured: 6weeks
Beck Depression Index
degree of depression with a questionnaire
Measured: 6 weeks
Pain Coping Inventory
inventory of the use of pain coping strategies with a questionnaiire
Measured: 6 weeks
Pain at tenderpoints
measuring tolerable pain at specified tenderpoints with an algometer
Measured: 6 weeks
Grip strength
measuring grip strength of both hands with a dynamometer
Measured: 6 weeks
Walking
6 minute walking test on a treadmill
Measured: 6 weeks
cycling
10 minutes cycling test on a hometrainer
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study startSep 2011
- Primary completionApr 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Alma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319355
- Sponsor's protocol ID
- EC/EH/111221
- Status last verified
- Oct 2017
- First submitted
- 5 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a 12-week Multicomponent Therapy in Fibromyalgia
- ClinicalTrials.gov ID
- NCT03319355
- Acronym / sponsor ID
- EC/EH/111221
- Conditions
- Fibromyalgia
- Keywords
- multicomponent therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- AZ Alma
- Study start
- Sep 2011 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 Oct 2017 (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.
Therapy for fibromyalgia is a well discussed topic in literature, yet not thoroughly evidence-based. Several unicomponent therapies seem to be benificial. Whereas multicomponent and multidisciplinary therapy gains importance and revealing promising results, the investigators aim to combine two well-known therapies in a program for patients with fibromyalgia.
From clinical experience, a high drop-out rate has been stated. All data will be explored to analyse explanatory factors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- woman with fibromyalgia
- between the age of 20 and 50
- agreement with therapy protocol
Key exclusion criteria (1 listed)
- high indication of depression measured with the Beck Depression Index
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 |
|---|---|---|
| cognitive behavioral therapyAlso: physical therapyexercise therapy | Behavioural | – |
Primary outcome
Fibromyalgia Impact Questionnaire
Time frame: 6weeks
impact of fibromyalgia on daily life with a questionnaire
Tampa scale for kinesiophobia
Time frame: 6weeks
rating the kinesiophobia with a questionnaire
Beck Depression Index
Time frame: 6 weeks
degree of depression with a questionnaire
Pain Coping Inventory
Time frame: 6 weeks
inventory of the use of pain coping strategies with a questionnaiire
Pain at tenderpoints
Time frame: 6 weeks
measuring tolerable pain at specified tenderpoints with an algometer
Grip strength
Time frame: 6 weeks
measuring grip strength of both hands with a dynamometer
Walking
Time frame: 6 weeks
6 minute walking test on a treadmill
cycling
Time frame: 6 weeks
10 minutes cycling test on a hometrainer
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 24 Oct 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy in people with Fibromyalgia, run by University Ghent.
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 3 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 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Fibromyalgia Impact Questionnaire (time frame: 6weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2017.