FibromyalgiaPhase 2NCT01266733
Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment
A Phase 2 study testing Interdisciplinary treatment and Interdisciplinary treatment of fibromyalgia in people with Fibromyalgia, run by Hospital Galdakao-Usansolo at 1 site in Spain.
Trial summary
The purpose of this study is to assess improvement in health related quality of life of fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Interdisciplinary treatment and Interdisciplinary treatment of fibromyalgia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2007to Feb 2010
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a patient must have been diagnosed with FM according to diagnostic criteria of the American College of Rheumatology
- being 18 years or older and
- having had continuous chronic pain for at least 6 months.
Who cannot join
- Patients were excluded if they did not agree to participate in the study,
- were suffering from a severe psychiatric or organic disorder, or
- were involved in employment-related legal proceedings related to their FM. Participants in the trial were required to sign an informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess improvement in health related quality of life of fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual treatment.
Read the detailed description
Fibromyalgia (FM) is the most common cause of diffuse pain in the bones and joints, with a prevalence in general adult populations estimated at between 0.7% and 3.3%. In Spain, the prevalence of FM is 2-3%; it affects mainly women, with new diagnoses peaking between the ages of 40 and 49 years. In certain populations, however, the prevalence may be much higher, as in 15% of patients referred from internal medicine units or 12% of patients referred to rheumatology specialists in Spain.
Fibromyalgia produces various degrees of disability and pain. It also has a clear impact on health-related quality of life (HRQoL). Burckhardt et al. observed lower HRQoL among patients with fibromyalgia than among healthy subjects. Indeed, the HRQoL for those with FM was similar to that of patients with insulin-dependent diabetes mellitus or chronic obstructive pulmonary disease. Among patients with non-cancer chronic pain referred to the pain management unit at our institution, those with bone and joint pain and with FM had the worst progress 6 months after diagnosis as measured by HRQoL.
The characteristics of FM, such as its complex and unknown etiology, wide range of symptoms and signs, and multiple comorbidities make identifying effective therapies particularly difficult. As a result, no consensus yet exists regarding the best therapeutic approaches, and treatment of FM presents a challenge for clinicians. Clinical research suggests that pharmacologic treatment alone is not the best approach for FM, and that an integrated biopsychosocial approach that includes non-pharmacologic therapies along with pharmacologic therapies improves outcomes in these patients.
In our hospital, between 5% and 10% of patients newly diagnosed with FM are referred to the pain management unit. We established a clinical trial in this population to assess improvement in HRQoL following 6 months of interdisciplinary treatment compared to the usual treatment, as well as to identify predictors for improvement in HRQoL.
- Conditions
- Fibromyalgia
- Being tested
- Interdisciplinary treatment, Interdisciplinary treatment of fibromyalgia
- Keywords
- fibromyalgia, non pharmacological intervention
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary treatmentBehavioural
Also called Interdisciplinary treatment of fibromyalgia
The Experimental Group received 6 weeks of interdisciplinary treatment of fibromyalgia combining coordinated psychological, medical, educational, and physiotherapeutic interventions delivered by a team that included a physician, a psychologist, and a physiotherapist.Patients in the EG were divided into groups of 12 individuals. Each attended biweekly group sessions of 1 hour and 45 minutes, for a total of 12 sessions. One session included 1 hour with the psychologist and 45 minutes of educational activities with the physician and psychologist, while the other session included 1 hour with the psychologist and 45 minutes with the physiotherapist.
Interdisciplinary treatment of fibromyalgiaBehavioural
The Control Group received the usual standard of care, which included pharmacologic treatment with a tricyclic antidepressant (amitriptyline, maximum dose of 75 mg/24h), an analgesic (paracetamol, maximum dose of 4 grams/24h), and a non-opioid central analgesic (tramadol, maximum dose of 400 mg/24h). The Experimental Group (EG) received 6 weeks of interdisciplinary treatment combining coordinated PSYchological, Medical, Educational, and PHYsiotherapeutic interventions (PSYMEPHY) delivered by a team that included a physician, a psychologist, and a physiotherapist. Patients in the EG were divided into groups of 12 individuals. Each attended biweekly group sessions of 1 hour and 45 minutes, for a total of 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary treatment | Experimental | Not described Receives: Behavioral: Interdisciplinary treatment; Behavioral: Interdisciplinary treatment of fibromyalgia |
| Usual treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire)
Fibromyalgia patients completed the FIQ at baseline and again 6 months after the interdisciplinary intervention.
Measured: 6 months
Secondary outcomes (1)
Anxiety and depressive symptoms (HADS: The Hospital Anxiety and Depression Scale)
Patients with fibromyalgia completed the HADS at baseline and again 6 months after the intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startFeb 2007
- Primary completionDec 2009
- Study completionFeb 2010
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Galdakao-Usansolo
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Josune Martin Corral, Hospital Galdakao-Usansolo
- Investigators
- Fernando Torre, Doctor, Principal investigator, Hospital Galdakao-Usansolo (Bizkaia) Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266733
- Sponsor's protocol ID
- 2006111057
- Status last verified
- Dec 2010
- First submitted
- 23 Dec 2010
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martin J, Torre F, Padierna A, Aguirre U, Gonzalez N, Matellanes B, Quintana JM. Impact of interdisciplinary treatment on physical and psychosocial parameters in patients with fibromyalgia: results of a randomised trial. Int J Clin Pract. 2014 May;68(5):618-27. doi: 10.1111/ijcp.12365. Epub 2014 Feb 20.
PubMed 24868587
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment
- ClinicalTrials.gov ID
- NCT01266733
- Acronym / sponsor ID
- 2006111057
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, non pharmacological intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Hospital Galdakao-UsansoloOther government
- Study start
- Feb 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 24 Dec 2010 (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.
The purpose of this study is to assess improvement in health related quality of life of fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual treatment.
Detailed description
Fibromyalgia (FM) is the most common cause of diffuse pain in the bones and joints, with a prevalence in general adult populations estimated at between 0.7% and 3.3%. In Spain, the prevalence of FM is 2-3%; it affects mainly women, with new diagnoses peaking between the ages of 40 and 49 years. In certain populations, however, the prevalence may be much higher, as in 15% of patients referred from internal medicine units or 12% of patients referred to rheumatology specialists in Spain.
Fibromyalgia produces various degrees of disability and pain. It also has a clear impact on health-related quality of life (HRQoL). Burckhardt et al. observed lower HRQoL among patients with fibromyalgia than among healthy subjects. Indeed, the HRQoL for those with FM was similar to that of patients with insulin-dependent diabetes mellitus or chronic obstructive pulmonary disease. Among patients with non-cancer chronic pain referred to the pain management unit at our institution, those with bone and joint pain and with FM had the worst progress 6 months after diagnosis as measured by HRQoL.
The characteristics of FM, such as its complex and unknown etiology, wide range of symptoms and signs, and multiple comorbidities make identifying effective therapies particularly difficult. As a result, no consensus yet exists regarding the best therapeutic approaches, and treatment of FM presents a challenge for clinicians. Clinical research suggests that pharmacologic treatment alone is not the best approach for FM, and that an integrated biopsychosocial approach that includes non-pharmacologic therapies along with pharmacologic therapies improves outcomes in these patients.
In our hospital, between 5% and 10% of patients newly diagnosed with FM are referred to the pain management unit. We established a clinical trial in this population to assess improvement in HRQoL following 6 months of interdisciplinary treatment compared to the usual treatment, as well as to identify predictors for improvement in HRQoL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary treatment | Experimental | Behavioral: Interdisciplinary treatment, Behavioral: Interdisciplinary treatment of fibromyalgia |
| Usual treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a patient must have been diagnosed with FM according to diagnostic criteria of the American College of Rheumatology
- being 18 years or older and
- having had continuous chronic pain for at least 6 months.
Key exclusion criteria (3 listed)
- Patients were excluded if they did not agree to participate in the study,
- were suffering from a severe psychiatric or organic disorder, or
- were involved in employment-related legal proceedings related to their FM. Participants in the trial were required to sign an informed consent form.
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 |
|---|---|---|
| Interdisciplinary treatmentAlso: Interdisciplinary treatment of fibromyalgiaThe Experimental Group received 6 weeks of interdisciplinary treatment of fibromyalgia combining coordinated psychological, medical, educational, and physiotherapeutic interventions delivered by a team that included a physician, a psychologist, and a physiotherapist.Patients in the EG were divided into groups of 12 individuals. Each attended biweekly group sessions of 1 hour and 45 minutes, for a total of 12 sessions. One session included 1 hour with the psychologist and 45 minutes of educational activities with the physician and psychologist, while the other session included 1 hour with the psychologist and 45 minutes with the physiotherapist. | Behavioural | Interdisciplinary treatment |
| Interdisciplinary treatment of fibromyalgiaThe Control Group received the usual standard of care, which included pharmacologic treatment with a tricyclic antidepressant (amitriptyline, maximum dose of 75 mg/24h), an analgesic (paracetamol, maximum dose of 4 grams/24h), and a non-opioid central analgesic (tramadol, maximum dose of 400 mg/24h). The Experimental Group (EG) received 6 weeks of interdisciplinary treatment combining coordinated PSYchological, Medical, Educational, and PHYsiotherapeutic interventions (PSYMEPHY) delivered by a team that included a physician, a psychologist, and a physiotherapist. Patients in the EG were divided into groups of 12 individuals. Each attended biweekly group sessions of 1 hour and 45 minutes, for a total of 12 sessions. | Behavioural | Interdisciplinary treatment |
Primary outcome
Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire)
Time frame: 6 months
Fibromyalgia patients completed the FIQ at baseline and again 6 months after the interdisciplinary intervention.
1 secondary outcome
Anxiety and depressive symptoms (HADS: The Hospital Anxiety and Depression Scale)
Time frame: 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 18 Jun 2015.
- Derived from this study: PubMed 24868587Martin J, Torre F, Padierna A, Aguirre U, Gonzalez N, Matellanes B, Quintana JM. Impact of interdisciplinary treatment on physical and psychosocial parameters in patients with fibromyalgia: results of a randomised trial. Int J Clin Pract. 2014 May;68(5):618-27. doi: 10.1111/ijcp.12365. Epub 2014 Feb 20.
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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.
Fernando Torre, Doctor principal investigator
Hospital Galdakao-Usansolo (Bizkaia) Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interdisciplinary treatment and Interdisciplinary treatment of fibromyalgia in people with Fibromyalgia, run by Hospital Galdakao-Usansolo at 1 site in Spain.
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 3 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 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire) (time frame: 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 NCT01266733, 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 18 Jun 2015.