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Relaxation may ease fibromyalgia pain in new study

NCT ID NCT01628822

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

80 people

The number who actually took part.

Start date

Jan 2012

Finished

Oct 2014

Lead sponsor

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

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.