Transcranial Magnetic Stimulation and/or Neurofunctional Electrical Acupuncture in the Rehabilitation of Patients With Myofascial Chronic Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Providing informed consent to participate in the study ;
- •18 to 70 years old;
- •Myofascial pain in the cranial- cervical- mandibular complex, with duration more than 3 months;
- •In the last week, score higher or equal to 3cm (0 cm = 'no pain' and 10cm ='worst possible pain') on the VAS for pain perception at the baseline in the most part of seven days before;
- •Refractoriness to drugs for pain relieve - such as tricyclic antidepressants, antiepileptic drugs and/or narcotics (pain resistant to at least 2 of these drugs supplied in adequate dosages for six months).
排除标准
- •Inflammatory chronic disease;
- •Neurological deficits;
- •History of substance abuse;
- •Neuropsychiatric co-morbidity;
- •Systemic diseases not well balance;
- •Habitual use of anti-inflammatory steroids;
- •Implanted devices for pain control, such as vagal or deep brain stimulators;
- •Contraindications to rTMS: metal in the head, implanted brain medical devices, previous convulsion or epilepsy, serious cranial trauma, audition problem, cochlear implant, neurostimulador implantable, spinal cord surgery, bypass valve ventriculoperitoneal peritonenal,cardiac pacemaker or other metal in the body;
- •Pregnancy;
- •Prior experience with acupuncture.
研究组 & 干预措施
Both Sham rTMS and Neuroacupuncture
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.
干预措施: Sham rTMS (Device)
Both Sham rTMS and Neuroacupuncture
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.
干预措施: Sham Neuroacupuncture (Device)
Active rTMS and 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.
干预措施: Active rTMS (Device)
Active rTMS and 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.
干预措施: Sham Neuroacupuncture (Device)
Sham rTMS and Active 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.
干预措施: Sham rTMS (Device)
Sham rTMS and Active 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.
干预措施: Active Neuroacupuncture (Device)
Both Active rTMS and 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.
干预措施: Active rTMS (Device)
Both Active rTMS and 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.
干预措施: Active Neuroacupuncture (Device)
结局指标
主要结局
Pain severity
时间窗: up to three months after the end of treatment
The intensity of pain was measured by a 10-cm VAS. VAS scores ranged from no pain (zero) to the worst possible pain (10cm).
次要结局
- Peripheral Biochemical Markers(The difference in the baseline, after one week of treatment and the end of the treatment (2 weeks after starting the treatment).)
- Functional Capacity(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 ).)
- Parameters of motor cortex excitability(The variation between the baseline and the end of treatment (2 weeks after starting the treatment).)
- Quality of Life(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(The variation between the baseline and the end of treatment (2 weeks after starting the treatment).)
研究者
Wolnei Caumo
The investigation of the effect of transcranial magnetic stimulation and / or Neurofunctional Electrical Acupuncture in the rehabilitation of patients with myofascial chronic pain
Hospital de Clinicas de Porto Alegre