FibromyalgiaPhase 3Sophrodol-1NCT01628822
Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia
A Phase 3 study testing Active relaxation in people with Fibromyalgia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The main objective of this protocol is to measure the improvement of the overall situation of patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment relaxation. Secondarily,is to evaluate the evolution of physical variables, psychological and social improvement of the quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Active relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Oct 2014
- Phase
- Phase 3
- 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
- Men or women over 18 years
- established diagnosis of fibromyalgia as defined by the American College of Rheumatology: widespread pain and eleven tender points at 18 sites listed (ACR, 1990)
- EVA ≥ 4 (on a scale of 10 cm)
- no change in treatment for 15 days, except for treatment "on demand" or "rescue"
- patient has given its written consent
- patient wishing to benefit from relaxation sessions
- people who can meet the self-assessment and hetero-assessment
- people with a social security number
Who cannot join
- any painful situation that cannot be distinguished from fibromyalgia pain by the patient
- patients untreated or treated for less than a month
- patient with psychosis or severe depression or severe anxiety or impulsivity characterized, at the discretion of the clinician.
- patients receiving benzodiazepines at the request
- patient with deafness
- patient after a body treatment using a relaxation method, relaxation therapy or hypnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study, Prospective, Single Center,Randomized, Single Blind, Evaluating the Efficacy of Relaxation to 12 Weeks Against Placebo, in the Overall Care Chronic Pain in Patients With Fibromyalgia
The main objective of this protocol is to measure the improvement of the overall situation of patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment relaxation.
Secondarily,is to evaluate the evolution of physical variables, psychological and social improvement of the quality of life. To evaluate the evolution of drug consumption
- Conditions
- Fibromyalgia
- Being tested
- Active relaxation, Placebo
- Keywords
- Fibromyalgia, Relaxation, Improving the quality of life
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active relaxationBehavioural
The length of follow-up will be 12 weeks.Patients will be seen once every seven days by a relaxation therapist for 5 weeks (6 sessions) and will be followed by the center physician investigator regarding drug therapy
PlaceboBehavioural
Patients are been asked to relax alone in a quiet room. They are coming every 7 days for 5 weeks (6 sessions) and will be followed by the investigator regarding drug therapy
| Study group | Role | What they receive |
|---|---|---|
| Active relaxation | Experimental | Not described Receives: Behavioral: Active relaxation |
| Placebo relaxation | Placebo comparator | Not described Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
scores on Fibromyalgia Impact Questionnaire (FIQ)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2014
- Study completionOct 2014
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 Centre Hospitalier Universitaire, AmiensThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SERRA Eric, Dr, Principal investigator, Activity Centre "Pain", University Hospital of Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628822
- Sponsor's protocol ID
- AOL11-DR-SERRA
- Other IDs
- 2011-A01055-36
- Acronym
- Sophrodol-1
- Status last verified
- Nov 2025
- First submitted
- 22 Jun 2012
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Douleur analg. (2023) 36:73-82 DOI 10.3166/dea-2022-0249, Efficacité de la relaxation dans la fibromyalgie : un essai clinique bref aléatoirement contrôlé en simple insu portant sur 80 patients
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study, Prospective, Single Center,Randomized, Single Blind, Evaluating the Efficacy of Relaxation to 12 Weeks Against Placebo, in the Overall Care Chronic Pain in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01628822
- Acronym / sponsor ID
- Sophrodol-1 / AOL11-DR-SERRA
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Relaxation, Improving the quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 27 Jun 2012 (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 main objective of this protocol is to measure the improvement of the overall situation of patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment relaxation.
Secondarily,is to evaluate the evolution of physical variables, psychological and social improvement of the quality of life. To evaluate the evolution of drug consumption
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active relaxation | Experimental | Behavioral: Active relaxation |
| Placebo relaxation | Placebo comparator | Behavioral: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women over 18 years
- established diagnosis of fibromyalgia as defined by the American College of Rheumatology: widespread pain and eleven tender points at 18 sites listed (ACR, 1990)
- EVA ≥ 4 (on a scale of 10 cm)
- no change in treatment for 15 days, except for treatment "on demand" or "rescue"
- patient has given its written consent
Key exclusion criteria (6 listed)
- any painful situation that cannot be distinguished from fibromyalgia pain by the patient
- patients untreated or treated for less than a month
- patient with psychosis or severe depression or severe anxiety or impulsivity characterized, at the discretion of the clinician.
- patients receiving benzodiazepines at the request
- patient with deafness
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 |
|---|---|---|
| Active relaxationThe length of follow-up will be 12 weeks.Patients will be seen once every seven days by a relaxation therapist for 5 weeks (6 sessions) and will be followed by the center physician investigator regarding drug therapy | Behavioural | Active relaxation |
| PlaceboPatients are been asked to relax alone in a quiet room. They are coming every 7 days for 5 weeks (6 sessions) and will be followed by the investigator regarding drug therapy | Behavioural | Placebo relaxation |
Primary outcome
scores on Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 12 weeks
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 19 Nov 2025.
- Results publicationDouleur analg. (2023) 36:73-82 DOI 10.3166/dea-2022-0249, Efficacité de la relaxation dans la fibromyalgie : un essai clinique bref aléatoirement contrôlé en simple insu portant sur 80 patients
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
SERRA Eric, Dr principal investigator
Activity Centre "Pain", University Hospital of Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active relaxation in people with Fibromyalgia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 8 inclusion and 6 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 19 Nov 2025. 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 France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
scores on Fibromyalgia Impact Questionnaire (FIQ) (time frame: 12 weeks). 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 NCT01628822, 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 19 Nov 2025.