Skip to content

Transcranial Magnetic Stimulation and/or Neurofunctional Electrical Acupuncture in Myofascial Chronic Pain Patients

Transcranial Magnetic Stimulation and/or Neurofunctional Electrical Acupuncture in the Rehabilitation of Patients With Myofascial Chronic Pain

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02381171
Enrollment
80
Registered
2015-03-06
Start date
2012-02-29
Completion date
2016-12-31
Last updated
2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain Syndromes

Keywords

myofacial pain, neuromodulation, repetitive transcranial magnetic stimulation, electroacupuncture

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.

Interventions

DEVICEActive rTMS

Repetitive Transcranial Magnetic Stimulation (rTMS) 10Hz (1600 pulses)

DEVICESham rTMS

Repetitive Transcranial Magnetic Stimulation (rTMS) with Placebo coil

DEVICEActive Neuroacupuncture

Neurofunctional electrical acupuncture 1Hz, continuous, 10mA current for 20 minutes.

DEVICESham Neuroacupuncture

Neurofunctional electrical acupuncture without needles

Sponsors

Federal University of Rio Grande do Sul
CollaboratorOTHER
Spaulding Rehabilitation Hospital
CollaboratorOTHER
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain severityup to three months after the end of treatmentThe intensity of pain was measured by a 10-cm VAS. VAS scores ranged from no pain (zero) to the worst possible pain (10cm).

Secondary

MeasureTime frameDescription
Peripheral Biochemical MarkersThe difference in the baseline, after one week of treatment and the end of the treatment (2 weeks after starting the treatment).Different peripheral biochemical: BDNF, TNF, S100 beta, interleukins, LDH, oxidative stress, catecolamines serum levels; 6-sulphatoxymelatonin urinary; salivary cortisol.
Parameters of motor cortex excitabilityThe variation between the baseline and the end of treatment (2 weeks after starting the treatment).Parameters of cortical excitability: motor threshold, motor-evoked potential, intracortical inhibition and facilitation, cortical silent period using transcranial magnetic stimulation technique.
Quality of LifeBaseline (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 )Using Quality of life questionnaire (WHOQOL-bref) with 26 questions.
Functional CapacityBaseline (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 ).Using The Brazilian Portuguese version of the Profile of Chronic Pain.
Pain thresholdThe variation between the baseline and the end of treatment (2 weeks after starting the treatment).Pain threshold assessed by algometer (pain pressure threshold) and quantitative sensory

Countries

Brazil

Contacts

Primary ContactWolnei Caumo, PhD
caumo@cpovo.net55 51 33598083
Backup ContactIraci S Torres, PhD
iracitorres@gmail.com55 51 33598083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026