Trial of Acupuncture in the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Pragmatic Randomized Controlled Trial of Acupuncture Effectiveness in the Treatment of Fibromyalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01189994
• Other study ID #: SCMRJH-001
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2010
• Last updated: September 3, 2010
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: September 2010
• Source: Santa Casa da Misericordia do Rio de Janeiro Hospital
• Contact: Fernando P de Farias, MD, PhD
• Phone: (+5521) 9263-8673
• Email: fernandopfarias[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Myofascial Pain Syndrome
• Fibromyalgia
• Fibromyalgia-Fibromyositis Syndrome
• Fibromyositis-Fibromyalgia Syndrome
• Myofascial Pain Syndrome, Diffuse
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• Acupuncture
Needling of acupoints, some of them receiving electrostimulation

Behavioral:
• Orientation
Orientation sessions focusing in fibromyalgia

Locations

Country	Name	City	State
Brazil	Santa Casa da Misericordia do Rio de Janeiro Hospital; Instituto de Acupuntura do Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Santa Casa da Misericordia do Rio de Janeiro Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire (FIQ) score		Twelve weeks from baseline	No
Secondary	Weekly Likert scale in pain diary		Twelve weeks from baseline	No
Secondary	Visual Analog Scale (VAS) for pain		Twelve weeks from baseline	No
Secondary	Short Form 36 (SF-36) score for quality of life		Twelve weeks from baseline	No
Secondary	Health Assessment Questionnaire - Disability Index (HAQ-DI) score		Twelve weeks from baseline	No
Secondary	Hospital Anxiety and Depression (HAD) Scale		Twelve weeks from baseline	No
Secondary	Fibromyalgia Impact Questionnaire (FIQ) score		Twenty-four weeks from baseline	No
Secondary	Weekly Likert scale in pain diary		Twenty-four weeks from baseline	No
Secondary	Visual Analog Scale (VAS) for pain		Twenty-four weeks from baseline	No
Secondary	Short Form 36 (SF-36) score for quality of life		Twenty-four weeks from baseline	No
Secondary	Health Assessment Questionnaire - Disability Index (HAQ-DI) score		Twenty-four weeks from baseline	No
Secondary	Hospital Anxiety and Depression (HAD) Scale		Twenty-four weeks from baseline	No