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

March 5, 2015 updated by: Wolnei Caumo, Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wolnei Caumo, PhD
  • Phone Number: 55 51 33598083
  • Email: caumo@cpovo.net

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Recruiting
        • Hospital de Clinicas de Porto Alegre - HCPA
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Liciane F Medeiros, MsC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 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.
Device: Sham rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS) with Placebo coil
Device: Sham Neuroacupuncture
Neurofunctional electrical acupuncture without needles
Other Names:
  • Sham Electrical Deep Intramuscular Stimulation
Sham Comparator: 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.
Device: Sham Neuroacupuncture
Neurofunctional electrical acupuncture without needles
Other Names:
  • Sham Electrical Deep Intramuscular Stimulation
Device: Active rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS) 10Hz (1600 pulses)
Sham Comparator: 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.
Device: Sham rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS) with Placebo coil
Device: Active Neuroacupuncture
Neurofunctional electrical acupuncture 1Hz, continuous, 10mA current for 20 minutes.
Other Names:
  • Electrical Deep Intramuscular Stimulation
Active Comparator: 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.
Device: Active rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS) 10Hz (1600 pulses)
Device: Active Neuroacupuncture
Neurofunctional electrical acupuncture 1Hz, continuous, 10mA current for 20 minutes.
Other Names:
  • Electrical Deep Intramuscular Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain severity
Time Frame: 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).
up to three months after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral Biochemical Markers
Time Frame: The 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.
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
Time Frame: The 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.
The variation between the baseline and the end of treatment (2 weeks after starting the treatment).
Quality of Life
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 )
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 )
Functional Capacity
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 ).
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 ).
Pain threshold
Time Frame: The 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
The variation between the baseline and the end of treatment (2 weeks after starting the treatment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Federal University of Rio Grande do Sul
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Spaulding Rehabilitation Hospital

Investigators

  • Principal Investigator: Wolnei Caumo, PhD, Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCPA-TMS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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