Diffuse Myofascial Pain Syndrome, Fibromyalgia, Fibromyalgia-Fibromyositis Syndrome, Fibromyositis-Fibromyalgia Syndrome, Myofascial Pain Syndrome, Diffuse
Conditions
Keywords
Fibromyalgia, Acupuncture, Randomized Controlled Trial, Pain, Quality of Life
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.
Interventions
PROCEDUREAcupuncture
Needling of acupoints, some of them receiving electrostimulation
BEHAVIORALOrientation
Orientation sessions focusing in fibromyalgia
Sponsors
Santa Casa da Misericordia do Rio de Janeiro Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fibromyalgia Impact Questionnaire (FIQ) score | Twelve weeks from baseline |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (VAS) for pain | Twelve weeks from baseline |
| Short Form 36 (SF-36) score for quality of life | Twelve weeks from baseline |
| Weekly Likert scale in pain diary | Twelve weeks from baseline |
| Hospital Anxiety and Depression (HAD) Scale | Twelve weeks from baseline |
| Fibromyalgia Impact Questionnaire (FIQ) score | Twenty-four weeks from baseline |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) score | Twelve weeks from baseline |
Countries
Brazil
Contacts
Primary ContactFernando P de Farias, MD, PhD
Outcome results
None listed