Clinical trial NCT01189994: Trial of Acupuncture in the Treatment of Fibromyalgia
Official title: Pragmatic Randomized Controlled Trial of Acupuncture Effectiveness in the Treatment of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Santa Casa da Misericordia do Rio de Janeiro Hospital
Sponsor class: OTHER
First posted: 2010-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ) score
timeFrame: Twelve weeks from baseline
Secondary outcomes:
measure: Weekly Likert scale in pain diary
timeFrame: Twelve weeks from baseline
measure: Visual Analog Scale (VAS) for pain
timeFrame: Twelve weeks from baseline
measure: Short Form 36 (SF-36) score for quality of life
timeFrame: Twelve weeks from baseline
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI) score
timeFrame: Twelve weeks from baseline
measure: Hospital Anxiety and Depression (HAD) Scale
timeFrame: Twelve weeks from baseline
measure: Fibromyalgia Impact Questionnaire (FIQ) score
timeFrame: Twenty-four weeks from baseline
measure: Weekly Likert scale in pain diary
timeFrame: Twenty-four weeks from baseline
measure: Visual Analog Scale (VAS) for pain
timeFrame: Twenty-four weeks from baseline
measure: Short Form 36 (SF-36) score for quality of life
timeFrame: Twenty-four weeks from baseline
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI) score
timeFrame: Twenty-four weeks from baseline
measure: Hospital Anxiety and Depression (HAD) Scale
timeFrame: Twenty-four weeks from baseline
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Santa Casa da Misericordia do Rio de Janeiro Hospital; Instituto de Acupuntura do Rio de Janeiro
state: RJ
Study officials:
affiliation: Santa Casa da Misericordia do Rio de Janeiro Hospital
name: Fernando P de Farias, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: