Relaxation may ease fibromyalgia pain in new study
NCT ID NCT01628822
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether relaxation therapy can reduce chronic pain and improve daily life in people with fibromyalgia. Eighty adults with fibromyalgia were randomly assigned to either active relaxation sessions with a therapist or to relax alone in a quiet room (placebo) for 12 weeks. Researchers measured changes in pain, physical function, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- relaxation therapy
- What this could lead to
- If it works, this could point toward a simple, drug-free way to help manage fibromyalgia symptoms.
- What could go wrong
- This is a small, single-center pilot study, so results may not apply widely. The placebo group also involves relaxation, which may reduce the difference seen.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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80 people
The number who actually took part.
- Start date
-
Jan 2012
- Finished
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Oct 2014
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Activity Centre "Pain"
Amiens, 80054, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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