Effect of Acupuncture on Craniomandibular Pain of Myofascial Origin.

Myofascial Pain Clinical Trial

Official title:

Effect of Acupuncture on Craniomandibular Pain of Myofascial Origin. A Randomized, Triple-blind, Placebo-controlled, Crossover Clinical Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05414695
• Other study ID #: 091900-000127-20
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: December 2022

Study information

• Verified date: June 2022
• Source: Universidad de la Republica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of miofascial pain in the craniomandibular/temporomandibular region (DC-TMD published criteria).

Exclusion Criteria:

• Pregnant woman

• Recent history of facial trauma

• Systemic diseases that can affect the musculoskeletal system (e.g. rheumatoid arthritis, lupus, etc).

Related Conditions & MeSH terms

• Facial Pain
• Myofascial Pain

Intervention

Device:
• real acupuncture
Device with acupuncture needles 25 × 0.22 mm, Cloud & Dragon Medical Device Co, Ltd, China. Needle penetrates the skin 4 mm
• Placebo acupuncture
Device with acupuncture needles 25 × 0.22 mm, Cloud & Dragon Medical Device Co, Ltd, China. Needle does not touch the skin.

Locations

Country	Name	City	State
Uruguay	Universidad de la República, School of Dentistry	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de la Republica

Country where clinical trial is conducted

Uruguay, 

References & Publications (2)

Lesage FX, Berjot S, Deschamps F. Clinical stress assessment using a visual analogue scale. Occup Med (Lond). 2012 Dec;62(8):600-5. doi: 10.1093/occmed/kqs140. Epub 2012 Sep 10. — View Citation

Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity change from baseline to follow-up.	A Visual Analogue Scale (VAS) which consists of a 100mm line, with two end points representing 0 ('no pain') and 100 ('worst pain').	through study completion, an average of 6 months
Secondary	Graded Chronic Pain Scale Version 2.0	Validated instrument for assessment of chronic pain in epidemiological and health services research	through study completion, an average of 6 months
Secondary	Muscle pain upon palpation.	Performed by calibrated and blind researchers following the DC-TMD criteria (www.rdc-tmdinternational.org/)	through study completion, an average of 6 months
Secondary	Clinical stress assessment using a visual analogue scale	The stress VAS consisted of a 100mm line, with two end points representing 0 ('none') and 100 ('as bad as it could be').	through study completion, an average of 6 months

External Links

•   STRICTA criteria