Thread embedding acupuncture for temporomandibular disorder: Protocol for a pilot randomized controlled trial
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0007421
- Lead Sponsor
- Kyung Hee University Oriental Medicine Hospital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1) regional pain in the unilateral or bilateral TMJ and masticatory muscles lasting >3 months intermittently or persistently
2) average pain intensity >40 mm on a 100 mm visual analogue scale (VAS) in the last week. (If the pain is on both sides, the one with the more pain
3) local pain in the jaw, temple, inner ear, or front of the ear caused by jaw movement, function, or parafunction according to the diagnostic criteria for temporomandibular disorders (DC/TMD)
4) myalgia, myofascial pain, or arthralgia identified by palpation assessment of the examiner according to the DC/TMD
5) adults aged 19–70 years who agree to participate in the clinical trial and provide written informed consent.
1) Pain caused or aggravated by traffic accidents or traumatic injuries.
2) History of surgery in the temporomandibular joint.
3) History of multiple pain disorders (e.g., rheumatoid arthritis, etc.) or neurological diseases (e.g., brain tumor, stroke, trigeminal neuralgia, etc.) that may interfere with the treatment effects or interpretation of results.
4) Taking steroids, immunosuppressants, psychiatric drugs, or other medication that may affect results.
5) Change in drug-taking history of analgesics, including non-steroidal anti-inflammatory drugs, within a month.
6) History of thread embedding acupuncture (TEA) on the facial region within a month.
7) History of hypersensitivity on TEA or severe keloid scar.
8) Inability to conduct TEA due to skin diseases (inflammation, scar, seborrheic dermatitis, or psoriasis on the treatment location) or blood coagulation disorders.
9) Pregnant women, women who are planning to get pregnant or in the case of lactation.
10) Participation in another clinical trial within a month before the date of selection, or plan to participate in another clinical trial during the treatment and follow-up period
11) Other conditions judged by the researchers to be ineligible to participate in the clinical trial.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 100mm Visual Analogue Scale (VAS) of average pain intensity on the temporomandibular joint in the last week
- Secondary Outcome Measures
Name Time Method 100mm Visual Analogue Scale (VAS) of maximum pain intensity on the temporomandibular joint in the last week;Vertical TMJ opening;Graded Chronic Pain version 2;Jaw Functional Limitation Scale-20;Patient Global Impression of Change;Korean version of Beck's Depression Index;Quality of life (Short form-12 healthy survey / EuroQol 5-dimensions 5-level);Treatment expectation;Analgesic drug consumption;Adverse events;Medical costs for economic evaluation