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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Needling of acupoints, some of them receiving electrostimulation
Orientation sessions focusing in fibromyalgia
Santa Casa da Misericordia do Rio de Janeiro Hospital; Instituto de Acupuntura do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
RECRUITINGFibromyalgia Impact Questionnaire (FIQ) score
Time frame: Twelve weeks from baseline
Weekly Likert scale in pain diary
Time frame: Twelve weeks from baseline
Visual Analog Scale (VAS) for pain
Time frame: Twelve weeks from baseline
Short Form 36 (SF-36) score for quality of life
Time frame: Twelve weeks from baseline
Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Time frame: Twelve weeks from baseline
Hospital Anxiety and Depression (HAD) Scale
Time frame: Twelve weeks from baseline
Fibromyalgia Impact Questionnaire (FIQ) score
Time frame: Twenty-four weeks from baseline
Weekly Likert scale in pain diary
Time frame: Twenty-four weeks from baseline
Visual Analog Scale (VAS) for pain
Time frame: Twenty-four weeks from baseline
Short Form 36 (SF-36) score for quality of life
Time frame: Twenty-four weeks from baseline
Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Time frame: Twenty-four weeks from baseline
Hospital Anxiety and Depression (HAD) Scale
Time frame: Twenty-four weeks from baseline
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