Clinical Trials Logo

Clinical Trial Summary

Myofascial pain is one of the most prevalent conditions within temporomandibular disorders. Despite its high prevalence, health systems pay insufficient attention to it. Patients frequently receive multiple unnecessary and sometimes aggressive treatments. In this context, acupuncture has been studied as a plausible therapy for these conditions. However, researchers have encountered various methodological difficulties when demonstrating its actual effect. The main historical challenge in this area involves the difficulties inherent to using appropriate acupuncture controls such as placebos that allow for double blinding and cause minimum tactile stimulation. In a previous study, a validated an improved novel placebo acupuncture non-penetrating device with double blinding capability was presented. This project will allow to test the performance of this new placebo acupuncture device in a clinical experimental setting. The study will try to determine the actual effectiveness of acupuncture in treating craniomandibular pain of myofascial origin. The design will be a randomized, triple blind, placebo controlled, crossover clinical trial. The protocol follows the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) recommendations, and ethical approval was obtained. The central hypothesis is that acupuncture will be more effective than a placebo. Another hypothesis is that neither patients nor acupuncturists will be able to distinguish real acupuncture devices from placebo devices. The study will include consecutive patients diagnosed with pain in the craniomandibular region of muscular/myofascial origin according to accepted criteria. Sample size calculations were made with the assumption of an 80% power and a statistical difference accepted at the 5% level. A total of 60 patients will be included. Patients will be randomly divided into two groups: real acupuncture or placebo. Five sessions will be performed on each patient on a weekly basis. The total time for each intervention will be 30 minutes. A crossover design will be applied after a "washout" period of 14 days. Outcome measures will include pain, stress levels, quality of life, and mandibular dynamics, using validated and published criteria. Baseline measurements will be taken pre-treatment and at each treatment session. Follow-up outcomes will be measured after three and six months. A strict protocol for bias control will be followed. The triple-blind design will prevent the patient, the acupuncturist, and the person performing the statistical analysis from knowing what type of treatment each patient receives each time. Examiners will be calibrated and blinded to the treatment status. Data will be analyzed using a generalized mixed model framework and logistic regression models. Also, Fisher's exact test will be used to analyze the devices' blinding capability.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05414695
Study type Interventional
Source Universidad de la Republica
Contact
Status Active, not recruiting
Phase N/A
Start date March 14, 2022
Completion date December 2022

See also
  Status Clinical Trial Phase
Completed NCT04157426 - Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae N/A
Enrolling by invitation NCT06029413 - Myo vs. Myofascial Injection for Myofascial Trigger Points N/A
Not yet recruiting NCT05637047 - Pulsed Radiofrequency vs Dry Needling in Myofascial Pain N/A
Completed NCT04057781 - Pain and Neck Dysfunction Following Dry Needling With and Without Intramuscular Electrical Stimulus. N/A
Recruiting NCT06036524 - Multi-modal Imaging of Myofascial Pain N/A
Completed NCT04897581 - BBTI vs PSR in Musculoskeletal Orofacial Pain Adults N/A
Completed NCT03398486 - The Effectiveness of Kinesiotaping and Inactivation of Trigger Points in Chronic Myofascial Pain of TMD N/A
Recruiting NCT05928884 - Ultrasound Imaging for Myofascial Pain
Completed NCT04790071 - Dry Needling Treatment in Hemiplegic Shoulder Pain N/A
Completed NCT03704311 - Evaluation of Mitochondrial Function in Myofascial Trigger Points Cohort Pilot Study Using High-resolution Respirometry N/A
Completed NCT05365932 - Evaluation of an Intra Auricular Device as a Treatment for Painful Temporo-Mandibular Disorders N/A
Completed NCT04628286 - Myofascial Induction Effects on Stabilometry Versus Sham Laser N/A
Completed NCT04628299 - Effects of the Myofascial Induction Technique Versus a Control Laser N/A
Completed NCT04884152 - Telerehabilitation in Individuals Temporomandibular Dysfunction With Bruxism N/A
Completed NCT01850420 - A Study of IMC-1 In Patients With Fibromyalgia Phase 2
Terminated NCT03028012 - TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone Phase 4
Completed NCT04929171 - Myofascial Pain and Central Sensitization
Completed NCT04040309 - PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles Phase 4
Completed NCT03651141 - The Effects of Soft Tissue Therapy and Exercise on Hamstring Tightness N/A
Recruiting NCT03885791 - Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain N/A