Clinical trial NCT02381171: Transcranial Magnetic Stimulation and/or Neurofunctional Electrical Acupuncture in Myofascial Chronic Pain Patients
Official title: Transcranial Magnetic Stimulation and/or Neurofunctional Electrical Acupuncture in the Rehabilitation of Patients With Myofascial Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Pain Syndromes
Keywords: myofacial pain
neuromodulation
repetitive transcranial magnetic stimulation
electroacupuncture
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: Spaulding Rehabilitation Hospital
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2015-03-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain severity
timeFrame: up to three months after the end of treatment
Secondary outcomes:
measure: Peripheral Biochemical Markers
timeFrame: The difference in the baseline, after one week of treatment and the end of the treatment (2 weeks after starting the treatment).
measure: Parameters of motor cortex excitability
timeFrame: The variation between the baseline and the end of treatment (2 weeks after starting the treatment).
measure: Quality of Life
timeFrame: 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 )
measure: Functional Capacity
timeFrame: 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 ).
measure: Pain threshold
timeFrame: The variation between the baseline and the end of treatment (2 weeks after starting the treatment).
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre - HCPA
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Wolnei Caumo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Botelho L, Angoleri L, Zortea M, Deitos A, Brietzke A, Torres ILS, Fregni F, Caumo W. Insights About the Neuroplasticity State on the Effect of Intramuscular Electrical Stimulation in Pain and Disability Associated With Chronic Myofascial Pain Syndrome (MPS): A Double-Blind, Randomized, Sham-Controlled Trial. Front Hum Neurosci. 2018 Oct 16;12:388. doi: 10.3389/fnhum.2018.00388. eCollection 2018.
citation: Medeiros LF, Caumo W, Dussan-Sarria J, Deitos A, Brietzke A, Laste G, Campos-Carraro C, de Souza A, Scarabelot VL, Cioato SG, Vercelino R, de Castro AL, Araujo AS, Bello-Klein A, Fregni F, Torres IL. Effect of Deep Intramuscular Stimulation and Transcranial Magnetic Stimulation on Neurophysiological Biomarkers in Chronic Myofascial Pain Syndrome. Pain Med. 2016 Jan;17(1):122-35. doi: 10.1111/pme.12919.