- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01964729
rTMS Effects in the Neuromodulation and Pain Threshold of Chronic Myofascial Pain Patients
Effect of Transcranial Magnetic Stimulation in the Cortical, Subcortical Neuromodulation and in Pain Threshold of Chronic Myofascial Pain Patients
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Wolnei Caumo, PhD
- Phone Number: +5551 3359 8083
- Email: caumo@cpovo.net
Study Locations
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90.450-120
- Recruiting
- Hospital de Clinicas de Porto Alegre
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Contact:
- Wolnei Caumo, PhD
- Phone Number: +5551 3359 8083
- Email: caumo@cpovo.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sham rTMS
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.
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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.
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Experimental: Transcranial Magnetic Stimulation
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.
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The participants will be randomized into placebo-sham or rTMS or treatment groups for 10 consecutive sessions, at 10 Hz frequency.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain threshold
Time Frame: An expected average of 3 months. (At baseline and at the end of intervention period).
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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.
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An expected average of 3 months. (At baseline and at the end of intervention period).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortical excitability parameters (MEP, ICF, CSP and SICI)
Time Frame: An expected average of 3 months. (At baseline and at the end or intervention period)
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The resting motor threshold (RMT) will be determined by obtaining five MEP with peak-to-peak amplitude of 50 µV out of ten consecutive trials.
Next, ten MEP will be recorded with an intensity set to 130% of the individual RMT.
Moreover, CSP will be performed during muscle activity measured by a dynamometer to be approximately 20% of maximal force.
Accordingly, ten CSP will be recorded using an intensity of 130% of the RMT.
SICI using an interstimulus interval of 2 ms was also assessed.
The first conditioning stimulus will be set at 80% of the RMT, whereas the second test stimulus will be set at 100% of the individual MEP intensity.
ICF will be assessed with an interstimulus interval of 12 ms.
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An expected average of 3 months. (At baseline and at the end or intervention period)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BDNF
Time Frame: An expected average of 3 months. (At baseline and at the end of intervention period).
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The BDNF will be measured bu ELISA
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An expected average of 3 months. (At baseline and at the end of intervention period).
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Wolnei Caumo, PhD, Hospital de Clinicas de Porto Alegre
- Principal Investigator: Letizzia Dall´Agnol, Federal University of Health Science of Porto Alegre
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 120343
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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