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

Myofascial Pain Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02381171
• Other study ID #: HCPA-TMS
• Status: Recruiting
• Phase: N/A
• First received: March 21, 2014
• Last updated: March 5, 2015
• Start date: February 2012
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Wolnei Caumo, PhD
• Phone: 55 51 33598083
• Email: caumo[@]cpovo.net
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Active rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS) 10Hz (1600 pulses)
• Sham rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS) with Placebo coil
• Active Neuroacupuncture
Neurofunctional electrical acupuncture 1Hz, continuous, 10mA current for 20 minutes.
• Sham Neuroacupuncture
Neurofunctional electrical acupuncture without needles

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre - HCPA	Porto Alegre	Rio Grande do Sul

Sponsors (4)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Federal University of Rio Grande do Sul, Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	up to three months after the end of treatment	Yes
Secondary	Peripheral Biochemical Markers	Different peripheral biochemical: BDNF, TNF, S100 beta, interleukins, LDH, oxidative stress, catecolamines serum levels; 6-sulphatoxymelatonin urinary; salivary cortisol.	The difference in the baseline, after one week of treatment and the end of the treatment (2 weeks after starting the treatment).	Yes
Secondary	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.	The variation between the baseline and the end of treatment (2 weeks after starting the treatment).	Yes
Secondary	Quality of Life	Using Quality of life questionnaire (WHOQOL-bref) with 26 questions.	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 )	Yes
Secondary	Functional Capacity	Using The Brazilian Portuguese version of the Profile of Chronic Pain.	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 ).	Yes
Secondary	Pain threshold	Pain threshold assessed by algometer (pain pressure threshold) and quantitative sensory	The variation between the baseline and the end of treatment (2 weeks after starting the treatment).	Yes