Trial of Acupuncture in the Treatment of Fibromyalgia

NCT01189994 | Unknown

• 1 other identifier: SCMRJH-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Fibromyalgia; Acupuncture; Randomized Controlled Trial; Pain; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia Impact Questionnaire (FIQ) score

  Twelve weeks from baseline

Secondary Outcomes (11)

• Weekly Likert scale in pain diary

  Twelve weeks from baseline

• Visual Analog Scale (VAS) for pain

  Twelve weeks from baseline

• Short Form 36 (SF-36) score for quality of life

  Twelve weeks from baseline

• Health Assessment Questionnaire - Disability Index (HAQ-DI) score

  Twelve weeks from baseline

• Hospital Anxiety and Depression (HAD) Scale

  Twelve weeks from baseline

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Procedure: Acupuncture

Orientation

ACTIVE COMPARATOR

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

Behavioral: Orientation

Interventions

Acupuncture PROCEDURE

Needling of acupoints, some of them receiving electrostimulation

Acupuncture

Orientation BEHAVIORAL

Orientation sessions focusing in fibromyalgia

Orientation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santa Casa da Misericordia do Rio de Janeiro Hospital: lead

Study Sites (1)

Santa Casa da Misericordia do Rio de Janeiro Hospital; Instituto de Acupuntura do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Fernando P de Farias, MD, PhD

  Santa Casa da Misericordia do Rio de Janeiro Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando P de Farias, MD, PhD

CONTACT

(+5521) 9263-8673; fernandopfarias@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 6, 2010

Record last verified: 2010-09

Locations

BR (1)