NCT02381171

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2014

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

3.8 years

First QC Date

March 21, 2014

Last Update Submit

March 5, 2015

Conditions

Myofascial Pain Syndromes

Keywords

myofacial painneuromodulationrepetitive transcranial magnetic stimulationelectroacupuncture

Outcome Measures

Primary Outcomes (1)

  • 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).

    up to three months after the end of treatment

Secondary Outcomes (5)

  • Peripheral Biochemical Markers

    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

    The variation between the baseline and the end of treatment (2 weeks after starting the treatment).

  • Quality of Life

    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

    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

    The variation between the baseline and the end of treatment (2 weeks after starting the treatment).

Study Arms (4)

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.

Device: Sham rTMSDevice: 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.

Device: Active rTMSDevice: 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.

Device: Sham rTMSDevice: 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.

Device: Active rTMSDevice: Active Neuroacupuncture

Interventions

Active rTMSDEVICE

Repetitive Transcranial Magnetic Stimulation (rTMS) 10Hz (1600 pulses)

Active rTMS and sham NeuroacupunctureBoth Active rTMS and Neuroacupuncture
Sham rTMSDEVICE

Repetitive Transcranial Magnetic Stimulation (rTMS) with Placebo coil

Both Sham rTMS and NeuroacupunctureSham rTMS and Active Neuroacupuncture
Active NeuroacupunctureDEVICE

Neurofunctional electrical acupuncture 1Hz, continuous, 10mA current for 20 minutes.

Also known as: Electrical Deep Intramuscular Stimulation
Both Active rTMS and NeuroacupunctureSham rTMS and Active Neuroacupuncture
Sham NeuroacupunctureDEVICE

Neurofunctional electrical acupuncture without needles

Also known as: Sham Electrical Deep Intramuscular Stimulation
Active rTMS and sham NeuroacupunctureBoth Sham rTMS and Neuroacupuncture

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Providing informed consent to participate in the study ;
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre - HCPA

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30459575DERIVED

  • Medeiros 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.

    PMID: 26408420DERIVED

MeSH Terms

Conditions

Myofascial Pain SyndromesFacial Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wolnei Caumo, PhD

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolnei Caumo, PhD

CONTACT

55 51 33598083caumo@cpovo.net

Iraci S Torres, PhD

CONTACT

55 51 33598083iracitorres@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The investigation of the effect of transcranial magnetic stimulation and / or Neurofunctional Electrical Acupuncture in the rehabilitation of patients with myofascial chronic pain

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 6, 2015

Study Start

February 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

BR(1)