An interventional study of Active rTMS and Sham rTMS in Myofascial Pain Syndromes, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-06.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment
To evaluate the hypothesis: the effects of repetitive transcranial magnetic (rTMS) stimulation and/or peripheral stimulation (neurofunctional electrical acupuncture) treatments are more effective in pain relief than placebo-sham in patients with myofascial chronic pain.
This project is a multidisciplinary study, with available technology, which aims are to provide more data to consolidate the techniques of central and peripheral neuromodulation in the treatment of myofascial pain with a component in the craniofacial complex . This is a randomized, double-dummy, factorial, blind, parallel, placebo - sham controlled clinical trial. The issues investigated in this study include important public health problem because chronic musculoskeletal pain affects 30 % of the world population , according to WHO. Around 75-80 % of people seeking health care for pain and that 40% of adults suffer from some type of chronic pain. According to the severity of the problem , the International Association for the Study of Pain has defined the year 2010 as the International Year Against Musculoskeletal Pain, facing the increasing prevalence and the limited impact of the classical therapeutic interventions ( \~ 30 % ). Possibly, part of this poor response is due to the limitation of pathophysiological knowledge, few resources in diagnostic methods and the consequent implementation of measures that do not reach the main routes of this disease process. It is important to mention that epidemiological studies have greatly contributed to improve the understanding of the process of these musculoskeletal diseases, but increase few knowledge about the understanding of the pathophysiology, diagnostic and therapeutic developments. It is important to highlight that evidence has shown strong association of musculoskeletal pathologies conditions and chronic stress. This relationship is cascading and permeated by manifestations suggest that the neuro-immune-endocrine axis, such as poor sleep quality, anxiety symptoms, depressive symptoms, increased susceptibility to infections and manifestations of neuro-vegetative dysfunctions. Thus, this project will examine whether the hypothesis that the application of central and peripheral neuromodulatory therapies can have a positive impact on possible systems implicated in the pathophysiological course of musculoskeletal disorders in the craniofacial complex, and evaluate clinical outcomes characterizing the process of rehabilitation of these patients.
1,143 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 937 interventional studies indexed under Myofascial Pain Syndromes.
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Exclusion Criteria:
Subjects will be randomized to receive 10 sessions of both sham treatments. Stimulation will be given on consecutive days (Monday- Friday) for 2 weeks: rTMSat 10hHz (1600pulses) over the primary motor cortex area and neurofunctional electrical acupuncture without current connection over peripheral region.
Device: Sham rTMS · Device: Sham Neuroacupuncture
Subjects will be randomized to receive 10 sessions of active rTMS and sham neurofunctional electrical acupuncture treatments. Stimulation will be given on consecutive days (Monday- Friday) for 2 weeks: rTMS at 10Hz (1600 pulses) over the primary motor cortex area and neurofunctional electrical acupuncture without current connection over peripheral region.
Device: Active rTMS · Device: Sham Neuroacupuncture
Subjects will be randomized to receive 10 sessions of sham rTMS and active Neurofunctional Electrical Acupuncture. Stimulation will be given on consecutive days (Monday- Friday) for 2 weeks: rTMS placebo coil over the primary motor cortex area and neurofunctional electrical acupuncture at 1Hz, continuous, 10mA current for 20 minutes over peripheral region.
Device: Sham rTMS · Device: Active Neuroacupuncture
Experimental Subjects will be randomized to receive 10 sessions of both active treatments. Stimulation will be given on consecutive days (Monday- Friday) for 2 weeks: rTMS at 10 Hz (1600 pulses) over the primary motor cortex area and neurofunctional electrical acupuncture at 1Hz, continuous, 10mA current for 20 minutes over peripheral region.
Device: Active rTMS · Device: Active Neuroacupuncture
Repetitive Transcranial Magnetic Stimulation (rTMS) 10Hz (1600 pulses)
Repetitive Transcranial Magnetic Stimulation (rTMS) with Placebo coil
Neurofunctional electrical acupuncture 1Hz, continuous, 10mA current for 20 minutes.
Also known as: Electrical Deep Intramuscular Stimulation
Neurofunctional electrical acupuncture without needles
Also known as: Sham Electrical Deep Intramuscular Stimulation
Pain severity
The intensity of pain was measured by a 10-cm VAS. VAS scores ranged from no pain (zero) to the worst possible pain (10cm).
Time frame: up to three months after the end of treatment
Peripheral Biochemical Markers
Different peripheral biochemical: BDNF, TNF, S100 beta, interleukins, LDH, oxidative stress, catecolamines serum levels; 6-sulphatoxymelatonin urinary; salivary cortisol.
Time frame: The difference in the baseline, after one week of treatment and the end of the treatment (2 weeks after starting the treatment).
Parameters of motor cortex excitability
Parameters of cortical excitability: motor threshold, motor-evoked potential, intracortical inhibition and facilitation, cortical silent period using transcranial magnetic stimulation technique.
Time frame: The variation between the baseline and the end of treatment (2 weeks after starting the treatment).
Quality of Life
Using Quality of life questionnaire (WHOQOL-bref) with 26 questions.
Time frame: Baseline (before the treatment) and after the treatment (after last session of treatment and follow-up of two weeks, one month and three months after the end of treatment )
Functional Capacity
Using The Brazilian Portuguese version of the Profile of Chronic Pain.
Time frame: Baseline (before the treatment) and after the treatment (after last session of treatment and follow-up of two weeks, one month and three months after the end of treatment ).
Pain threshold
Pain threshold assessed by algometer (pain pressure threshold) and quantitative sensory
Time frame: The variation between the baseline and the end of treatment (2 weeks after starting the treatment).
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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