Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01628822

Acronym

Sophrodol-1

Enrollment

Registered

2012-06-27

Start date

2012-01-31

Completion date

2014-10-31

Last updated

2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Relaxation, Improving the quality of life

Brief 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. To evaluate the evolution of drug consumption

Interventions

BEHAVIORALActive relaxation

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

BEHAVIORALPlacebo

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
scores on Fibromyalgia Impact Questionnaire (FIQ)	12 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026