An interventional study of real acupuncture and Placebo acupuncture in Myofascial Pain and Craniofacial Pain, sponsored by Universidad de la Republica. Status unknown at 1 site in Uruguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-10.
Sponsored by Universidad de la Republica · Not applicable, Interventional, and Treatment
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.
182 studies on the registry are indexed under Facial Pain; 61 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 132 interventional studies indexed under Facial Pain.
Browse Facial Pain studies →Universidad de la Republica is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The patient receives five sessions (weekly) of real acupuncture treatment in the acupuncture points LI4, S6, S7 and SI18. Each session lasts 30 minutes.
Device: real acupuncture
The patient receives five sessions (weekly) of placebo acupuncture in the same acupuncture points LI4, S6, S7 and SI18. Each session lasts 30 minutes. The placebo and real acupuncture devices have the same visual features but in the placebo device the needle does not even touch the skin.
Device: Placebo acupuncture
Device with acupuncture needles 25 × 0.22 mm, Cloud \& Dragon Medical Device Co, Ltd, China. Needle penetrates the skin 4 mm
Device with acupuncture needles 25 × 0.22 mm, Cloud \& Dragon Medical Device Co, Ltd, China. Needle does not touch the skin.
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').
Time frame: through study completion, an average of 6 months
Graded Chronic Pain Scale Version 2.0
Validated instrument for assessment of chronic pain in epidemiological and health services research
Time frame: through study completion, an average of 6 months
Muscle pain upon palpation.
Performed by calibrated and blind researchers following the DC-TMD criteria (www.rdc-tmdinternational.org/)
Time frame: through study completion, an average of 6 months
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').
Time frame: through study completion, an average of 6 months
Plan to share: Yes — All IPD that underlie results in a publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Starting one month after publication and for one year.
Access criteria: IPD and any additional supporting information will be shared to researchers worldwide upon direct request to the Principal Investigator (Marcelo Kreiner).
Started Mar 2022 (actual). Primary completion is estimated for Oct 2022, 7 months after the start.
Of 53 non-industry interventional studies with no phase under Facial Pain, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 7 months is below that.
Counting every sponsor, half of 57 studies reached it within 17 months; a quarter within 8 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Universidad de la Republica