Clinical trial NCT01964729: rTMS Effects in the Neuromodulation and Pain Threshold of Chronic Myofascial Pain Patients
Official title: Effect of Transcranial Magnetic Stimulation in the Cortical, Subcortical Neuromodulation and in Pain Threshold of Chronic Myofascial Pain Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Pain
Keywords: rTMS
Pain threshold
Neuromodulation
Myofascial
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2013-10-17
Enrollment: 24
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: About 30% of the world population suffers from pain. These data demonstrate the great need for research focusing on findings that contribute to the development of more effectivetreatments for patients with chronic pain syndromesThe chronic pain can occur by various means, either physical or psychological injuries. Above all, whatever its history, its installation is due to mechanisms of neuroplasticity, in this case non-functional, called maladaptive plasticity. This process and the symptoms associated with chronic pain cause the treatment to be a challenge for health professionals. To obtain a positive result, it is necessary to modulate all aspects involved in the processing of pain, including functional retraining.

This study is a randomized, blinded, parallel medical trial, placebo-sham- controlled and will be carried out int the Clinical Research Outpatient Clinic of the Hospital de Clínicas de Porto Alegre (HCPA), with females, aged 19 to 65 years, who are limited in their ability to perform active and routine activities due to MPS in the previous 3 months. We will test the hypothesis that repetitive transcranial magnetic stimulation (rTMS) would be more effective than a placebo-sham for the treatment of chronic MPS by pain score, cortical excitability parameters, function of cortical-spinal modulatory system (CSMS), sleep quality and serum BDNF.The participants will be randomized into the placebo-sham or rTMS treatment groups for 10 consecutive sessions, at 10 Hz frequency. To assessment will be used the visual analogue scale (VAS), Brazilian Profile of Chronic Pain: Screen (B-PCP:S), quantitative sensory testing (QST), TMS parameters, (motor-evoked potential (MEP), intracortical facilitation (ICF) ) and serum BDNF.

Through, these data will prompt us to investigate whether rTMS can be used as a therapeutic option in short and long term in MPS. In this context, we will test the hypothesis that rTMS would be more effective than a placebo-sham for the treatment of chronic MPS that determined some disability. We also will teste whether rTMS would change induced changes in both electrophysiological markers of LTP-like phenomena and in the levels of BDNF. Additionally, we will assess whether the treatment induce changes on the cortical-spinal modulatory system, as well if this effect would be associated with the inhibition or facilitation. Finally, we will test whether rTMS would be more effective than a placebo-sham in improving sleep quality.

Eligibility criteria: Inclusion Criteria: Will be included in the study female literate patients, with chronic myofascial pain of the craniomandibular complex (duration longer than 3 months). Must submit at least one (1) myofascial trigger point pain and restriction of neck mobility, skull or face and / or shoulder girdle, at the time of evaluation. Also, patients should report verbally have had pain and / or discomfort in a mean score greater than or equal to 30 mm, at least 7 consecutive days pre-treatment, to be measured on the visual analog scale (VAS) (scores ranging from 0 to 100 mm).

Exclusion Criteria: Will be excluded from the study patients with neurological deficits, systemic diseases unbalanced, fibromyalgia, chronic inflammatory diseases. Moreover, those who are using steroids.

Primary outcomes:
measure: Pain threshold
timeFrame: An expected average of 3 months. (At baseline and at the end of intervention period).
Secondary outcomes:
measure: Cortical excitability parameters (MEP, ICF, CSP and SICI)
timeFrame: An expected average of 3 months. (At baseline and at the end or intervention period)
Other outcomes:
measure: BDNF
timeFrame: An expected average of 3 months. (At baseline and at the end of intervention period).
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Wolnei Caumo, PhD
role: STUDY_CHAIR
affiliation: Federal University of Health Science of Porto Alegre
name: Letizzia Dall´Agnol
role: PRINCIPAL_INVESTIGATOR
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