Trial of Acupuncture in the Treatment of Fibromyalgia

Santa Casa da Misericordia do Rio de Janeiro Hospital

Status: Unknown

Conditions: Fibromyalgia; Myofascial Pain Syndrome, Diffuse; Fibromyalgia-Fibromyositis Syndrome; Diffuse Myofascial Pain Syndrome; Fibromyositis-Fibromyalgia Syndrome

Treatments: Behavioral: Orientation; Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01189994

SCMRJH-001

Details and patient eligibility

About

Fibromyalgia is a medical condition characterized by musculoskeletal pain, fatigue, sleep disturbances and depression. It affects population at a socioeconomically active age and represents a burden for the patients and the health care system due to its personal and functional implications. At this moment, there is no completely effective treatment for fibromyalgia, and acupuncture has been a promising alternative. This trial aims to evaluate if addition of acupuncture to standard care represents an improvement in comparison with standard care only. Thus, patients enrolled in this trial will be randomly allocated into one of two groups: group A, who besides standard treatment will receive 12 sessions of acupuncture; and group B, who will receive standard care with monthly orientation sessions for the same period. Patients will be evaluated at baseline, after completion of acupuncture treatment or orientation, and after an additional 12-week follow up. Evaluation will be based on diaries of pain and medication, and standard scales of pain, quality of life and disability.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American College of Rheumatology criteria for fibromyalgia
• elementary school
• drug treatment for at least 30 days (if any)

Exclusion criteria

• disabling mental condition
• other rheumatic conditions
• other chronic medical conditions with musculoskeletal symptoms
• pregnancy
• conditions that impair walking
• conditions that impair weekly consultations
• acupuncture treatment in the twelve-month period prior to enrollment
• diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Acupuncture

Experimental group

Description:

Patients will receive acupuncture treatment in addition to standard care, coming to twelve weekly acupuncture sessions

Treatment:

Procedure: Acupuncture

Orientation

Active Comparator group

Description:

Patients will receive standard care only, coming to three monthly orientation sessions

Treatment:

Behavioral: Orientation