rTMS Effects in the Neuromodulation and Pain Threshold of Chronic Myofascial Pain Patients

NCT01964729 | Unknown Phase 2 DMC

• 1 other identifier: 120343
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate if rTMS may have a positive impact on pain thresholds and cortical excitability in subjects with chronic musculoskeletal diseases of complex cranio-cervical-mandibular with myofascial component.

Conditions

Chronic Pain

Keywords

rTMS; Pain threshold; Neuromodulation; Myofascial

Outcome Measures

Primary Outcomes (1)

• Pain threshold

  The primary outcome will be pain, as assessed by the pain score diaries \[global pain in the last 24 hours, and the score on Brazilian Profile of Chronic Pain: Screen (B-PCP:S) the amount of analgesics used weekly throughout the treatment period, the effect of treatment on modulates corticospinal excitability assessed by evoked pain by Quantitative Sensory Testing (QST) during Conditional Pain Modulation (CPM) and the level of BDNF.

  An expected average of 3 months. (At baseline and at the end of intervention period).

Secondary Outcomes (1)

• Cortical excitability parameters (MEP, ICF, CSP and SICI)

  An expected average of 3 months. (At baseline and at the end or intervention period)

Other Outcomes (1)

• BDNF

  An expected average of 3 months. (At baseline and at the end of intervention period).

Study Arms (2)

Sham rTMS

SHAM COMPARATOR

Sham Comparator: For the placebo-controlled condition, we will use the same TMS equipment coupled with a placebo coil that produces the same active sound produced by the active coil.

Device: Sham rTMS

Transcranial Magnetic Stimulation

EXPERIMENTAL

We will deliver high frequency rTMS at 10 Hz rate was over right M1 in sessions consisting of of 4 seconds of stimulation followed by 26 second intervals, with a total of 1600 pulses per session.

Device: rTMS

Interventions

rTMS DEVICE

The participants will be randomized into placebo-sham or rTMS or treatment groups for 10 consecutive sessions, at 10 Hz frequency.

Transcranial Magnetic Stimulation

Sham rTMS DEVICE

Sham Comparator: For the placebo-controlled condition, we will use the same TMS equipment coupled with a placebo coil that produces the same active sound produced by the active coil.

Sham rTMS

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90.450-120, Brazil

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wolnei Caumo, PhD

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

• Letizzia Dall´Agnol

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolnei Caumo, PhD

CONTACT

+5551 3359 8083; caumo@cpovo.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor and coordinator of Pain & Neuromodulation Lab

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 17, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 21, 2013

Record last verified: 2013-10

Locations

BR (1)