Effect of stimulation with electrical current in fibromyalgia:randomized clinical trial

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2015
INTERVENTION: E02.342 E02.342.800 E02.779.483 The subjects, included in the study, will be randomly divided into five groups: exercise + TENS, exercise + placebo, motor intensity IFC, sensorial intensity IFC and placebo IFC. In the exercise + TENS group: Twelve patients will receive 24 treatment sessions, each session consists of an exercise protocol and application of TENS. The exercise protocol consists of 10 minutes of stretching, 10 minutes of aerobic exercise and 10 minutes of muscle strengthening. After the exercise, a transcutaneous electrical nerve stimulation (TENS) will be applied on paravertebral region for 30 minutes. Four auto‐adhesive electrodes will be placed, in parallel, on the upper angle of the scapula region and lumbar spine, just above the iliac crests. An alternated frequency of 4 Hz and 100Hz, 100 us pulse duration will be used. The pulse amplitude or intensity of stimulation will be maintained at a strong but comfortable level reported by the subject. At 5‐minute intervals, the intensity level will be increased again. In the exercise + placebo group: Twelve patients will also receive 24 treatment sessions, each session consists of an exercise protocol, previously described, and application of placebo. For the application of placebo, the electrodes are applied in the paravertebral region, but the TENS device will only work in the first 45 seconds, then no current will be released to the patient. In the motor intensity group: the interferential current (IFC) will be administered in 12 patients, for 10 treatment sessions. The electrodes will be placed as above. A beat frequency of 100 Hz will be applied for 30 minutes and the stimulation intensity will be gradually increased until a strong, but comfortable intensity level, with motor contraction. At 5‐minute intervals, the intensity will be increased again to a subjective strong but comfortable intensity. In the sensorial intensity group: Twelve patients will also receive the CI in the paravertebral region for 30 minutes in 10 CONDITION: C05.651.324 Fibromyalgia ; C05.651.324 PRIMARY OUTCOME: Reduction of pain of the patients submitted treatment with analgesic currents. For the assessment of pain reduction, the numerical scale of 11 points, pressure pain threshold, Mcgill pain questionnaire, temporal summation test and modulation conditioned of pain test will be used. And for verification the expected outcome, a variation of at least 5% in each test, questionnaire and scale used pre and post intervention will be considered. SECONDARY OUTCOME: Improves quality of life, reducing depression, anxiety, physical disability and pain‐related negative expectations. To assess these variables, will be used: the Fibromyalgia Impact Questionnaire (FIQ), Roland Morris Disability Questionnaire (RMDQ), Short Form 36 Health Survey (SF‐36), Beck Depression Inventory (BDI), State‐Trait Anxiety Inventory (STAI), Pain Catastrophizing Scale and Tampa Kinesiophobia Scale. And for verification of the expected outcomes, a variation of at least 5% in each scale and questionnaire used pre and post treatment will be considered. INCLUSION CRITERIA: Will be included patients with fibromyalgia, diagnosed according to the criteria of the American College of Rheumatology, female, aged 18 to 60 years, without physical therapy concomitant.
Epistemonikos ID: ab6b9e95cea860474b41e11240954ddd85e50c8c
First added on: Aug 23, 2024