Trial of Acupuncture in the Treatment of Fibromyalgia

NCT01189994 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-09-06

No results posted yet for this study

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

Interventions

PROCEDURE

Acupuncture

Needling of acupoints, some of them receiving electrostimulation

BEHAVIORAL

Orientation

Orientation sessions focusing in fibromyalgia

Sponsors & Collaborators

  • Santa Casa da Misericordia do Rio de Janeiro Hospital

    lead OTHER

Principal Investigators

  • Fernando P de Farias, MD, PhD · Santa Casa da Misericordia do Rio de Janeiro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01189994 on ClinicalTrials.gov