Myofascial Pain SyndromesNCT02381171
Transcranial Magnetic Stimulation and/or Neurofunctional Electrical Acupuncture in Myofascial Chronic Pain Patients
A study testing Active rTMS and Active Neuroacupuncture in people with Myofascial Pain Syndromes, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myofascial Pain Syndromes
- What is being tested?
- Active rTMS and Active Neuroacupuncture
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Inflammatory chronic disease;
- Neurological deficits;
- History of substance abuse;
- Neuropsychiatric co-morbidity;
- Systemic diseases not well balance;
- Habitual use of anti-inflammatory steroids;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre - HCPA
Porto Alegre, Rio Grande do Sul
Wolnei Caumo, PhD, +55 51 33598083, caumo@cpovo.net
Iraci LS Torres, PhD, +55 51 33598083, iracitorres@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Myofascial Pain Syndromes
- Being tested
- Active rTMS, Sham rTMS, Active Neuroacupuncture, Sham Neuroacupuncture
- Keywords
- myofacial pain, neuromodulation, repetitive transcranial magnetic stimulation, electroacupuncture
- Medical subject headings
- Myofascial Pain Syndromes, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
Repetitive Transcranial Magnetic Stimulation (rTMS) 10Hz (1600 pulses)
Sham rTMSDevice
Repetitive Transcranial Magnetic Stimulation (rTMS) with Placebo coil
Active NeuroacupunctureDevice
Also called Electrical Deep Intramuscular Stimulation
Neurofunctional electrical acupuncture 1Hz, continuous, 10mA current for 20 minutes.
Sham NeuroacupunctureDevice
Also called Sham Electrical Deep Intramuscular Stimulation
Neurofunctional electrical acupuncture without needles
| Study group | Role | What they receive |
|---|---|---|
| Both Sham rTMS and Neuroacupuncture | Sham comparator | 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. Receives: Device: Sham rTMS; Device: Sham Neuroacupuncture |
| Active rTMS and sham Neuroacupuncture | Sham comparator | 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. Receives: Device: Active rTMS; Device: Sham Neuroacupuncture |
| Sham rTMS and Active Neuroacupuncture | Sham comparator | 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. Receives: Device: Sham rTMS; Device: Active Neuroacupuncture |
| Both Active rTMS and Neuroacupuncture | Active comparator | 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. Receives: Device: Active rTMS; Device: Active Neuroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to three months after the end of treatment
Secondary outcomes (5)
Peripheral Biochemical Markers
Different peripheral biochemical: BDNF, TNF, S100 beta, interleukins, LDH, oxidative stress, catecolamines serum levels; 6-sulphatoxymelatonin urinary; salivary cortisol.
Measured: 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
Parameters of cortical excitability: motor threshold, motor-evoked potential, intracortical inhibition and facilitation, cortical silent period using transcranial magnetic stimulation technique.
Measured: The variation between the baseline and the end of treatment (2 weeks after starting the treatment).
Quality of Life
Using Quality of life questionnaire (WHOQOL-bref) with 26 questions.
Measured: 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
Using The Brazilian Portuguese version of the Profile of Chronic Pain.
Measured: 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
Pain threshold assessed by algometer (pain pressure threshold) and quantitative sensory
Measured: The variation between the baseline and the end of treatment (2 weeks after starting the treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startFeb 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Spaulding Rehabilitation Hospital, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Wolnei Caumo, Hospital de Clinicas de Porto Alegre
- Investigators
- Wolnei Caumo, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381171
- Sponsor's protocol ID
- HCPA-TMS
- Status last verified
- Mar 2015
- First submitted
- 21 Mar 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Botelho L, Angoleri L, Zortea M, Deitos A, Brietzke A, Torres ILS, Fregni F, Caumo W. Insights About the Neuroplasticity State on the Effect of Intramuscular Electrical Stimulation in Pain and Disability Associated With Chronic Myofascial Pain Syndrome (MPS): A Double-Blind, Randomized, Sham-Controlled Trial. Front Hum Neurosci. 2018 Oct 16;12:388. doi: 10.3389/fnhum.2018.00388. eCollection 2018.
PubMed 30459575Medeiros LF, Caumo W, Dussan-Sarria J, Deitos A, Brietzke A, Laste G, Campos-Carraro C, de Souza A, Scarabelot VL, Cioato SG, Vercelino R, de Castro AL, Araujo AS, Bello-Klein A, Fregni F, Torres IL. Effect of Deep Intramuscular Stimulation and Transcranial Magnetic Stimulation on Neurophysiological Biomarkers in Chronic Myofascial Pain Syndrome. Pain Med. 2016 Jan;17(1):122-35. doi: 10.1111/pme.12919.
PubMed 26408420
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation and/or Neurofunctional Electrical Acupuncture in the Rehabilitation of Patients With Myofascial Chronic Pain
- ClinicalTrials.gov ID
- NCT02381171
- Acronym / sponsor ID
- HCPA-TMS
- Conditions
- Myofascial Pain Syndromes
- Keywords
- myofacial pain, neuromodulation, repetitive transcranial magnetic stimulation, electroacupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Spaulding Rehabilitation Hospital, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Feb 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Both Sham rTMS and Neuroacupuncture | Sham comparator | Device: Sham rTMS, Device: Sham NeuroacupunctureSubjects 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. |
| Active rTMS and sham Neuroacupuncture | Sham comparator | Device: Active rTMS, Device: Sham NeuroacupunctureSubjects 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. |
| Sham rTMS and Active Neuroacupuncture | Sham comparator | Device: Sham rTMS, Device: Active NeuroacupunctureSubjects 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. |
| Both Active rTMS and Neuroacupuncture | Active comparator | Device: Active rTMS, Device: Active NeuroacupunctureExperimental 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- Inflammatory chronic disease;
- Neurological deficits;
- History of substance abuse;
- Neuropsychiatric co-morbidity;
- Systemic diseases not well balance;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active rTMSRepetitive Transcranial Magnetic Stimulation (rTMS) 10Hz (1600 pulses) | Device | Active rTMS and sham Neuroacupuncture, Both Active rTMS and Neuroacupuncture |
| Sham rTMSRepetitive Transcranial Magnetic Stimulation (rTMS) with Placebo coil | Device | Both Sham rTMS and Neuroacupuncture, Sham rTMS and Active Neuroacupuncture |
| Active NeuroacupunctureAlso: Electrical Deep Intramuscular StimulationNeurofunctional electrical acupuncture 1Hz, continuous, 10mA current for 20 minutes. | Device | Both Active rTMS and Neuroacupuncture, Sham rTMS and Active Neuroacupuncture |
| Sham NeuroacupunctureAlso: Sham Electrical Deep Intramuscular StimulationNeurofunctional electrical acupuncture without needles | Device | Active rTMS and sham Neuroacupuncture, Both Sham rTMS and Neuroacupuncture |
Primary outcome
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).
5 secondary outcomes
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).
Parameters of motor cortex excitability
Time frame: 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 )
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 ).
Pain threshold
Time frame: The variation between the baseline and the end of treatment (2 weeks after starting the treatment).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Derived from this study: PubMed 30459575Botelho L, Angoleri L, Zortea M, Deitos A, Brietzke A, Torres ILS, Fregni F, Caumo W. Insights About the Neuroplasticity State on the Effect of Intramuscular Electrical Stimulation in Pain and Disability Associated With Chronic Myofascial Pain Syndrome (MPS): A Double-Blind, Randomized, Sham-Controlled Trial. Front Hum Neurosci. 2018 Oct 16;12:388. doi: 10.3389/fnhum.2018.00388. eCollection 2018.
- Derived from this study: PubMed 26408420Medeiros LF, Caumo W, Dussan-Sarria J, Deitos A, Brietzke A, Laste G, Campos-Carraro C, de Souza A, Scarabelot VL, Cioato SG, Vercelino R, de Castro AL, Araujo AS, Bello-Klein A, Fregni F, Torres IL. Effect of Deep Intramuscular Stimulation and Transcranial Magnetic Stimulation on Neurophysiological Biomarkers in Chronic Myofascial Pain Syndrome. Pain Med. 2016 Jan;17(1):122-35. doi: 10.1111/pme.12919.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolnei Caumo, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS and Active Neuroacupuncture in people with Myofascial Pain Syndromes, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolnei Caumo, PhD (55 51 33598083, caumo@cpovo.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity (time frame: up to three months after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02381171, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.