Thread embedding acupuncture for temporomandibular disorder

Thread embedding acupuncture for temporomandibular disorder: A randomized controlled clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0009946

Enrollment

Registered

2024-11-22

Start date

2024-10-25

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : The TEA group will be treated with TEA conducted once a week for six weeks, A total of 16 TEA 29G x 25mm needles with 30mm threads will be inserted into the following eight acupoin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Regional pain in the temporomandibular joint (TMJ) and surrounding areas (temple, inner ear, in front of the ear) persisting for more than three months, related to jaw movement, function, or parafunction, according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). 2) Diagnosis of a pain disorder confirmed through palpation of the masticatory muscles or TMJ by the examiner, according to the DC/TMD criteria. 3) Average pain intensity of =40 mm on a 100 mm Visual Analogue Scale (VAS) over the past week, with the more severe side assessed in cases of bilateral pain. 4) Adults aged 19–70 who have received a full explanation of the study and provided signed informed consent.

Exclusion criteria

Exclusion criteria: 1) History of thread embedding acupuncture (TEA) or injection treatment in the facial region within the past three months. 2) Changes in the use of pain-related medications, including non-steroidal anti-inflammatory drugs (NSAIDs), within the past month. 3) Previous surgery involving the temporomandibular joint (TMJ). 4) Multiple pain disorders (e.g., rheumatoid arthritis) or neurological conditions (e.g., trigeminal neuralgia, herpes zoster) that could influence TMJ pain. 5) Skin conditions or blood coagulation disorders (e.g., inflammation, wounds, anticoagulant use) that contraindicate thread embedding acupuncture. 6) Pregnancy or planned pregnancy 7) Mental disorders or communication difficulties that would prevent adherence to clinical trial protocols.

Design outcomes

Primary

Measure	Time frame
100mm Visual Analogue Scale (VAS) of average pain intensity in the last week	—

Secondary

Measure	Time frame
100mm Visual Analogue Scale (VAS) of maximum pain intensity in the last week;Vertical temporomandibular joint opening;Graded Chronic Pain 2.0;Jaw Functional Limitation Scale 20;Patient Global Impression of Change;Quality of life (EuroQol 5-dimensions 5-level);Treatment expectation;Adverse events;Medical costs for economic evaluation	—

Countries

Korea, Republic of

Contacts

Public ContactBonhyuk Goo

Kyung Hee University Oriental Medicine Hospital at Gangdong

goossi9@hanmail.net+82-2-440-6099

Outcome results