An interventional study of Dry Needling and sham needling in TMD/Orofacial Pain and Muscle Spasm, sponsored by Atlas University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Atlas University · Not applicable, Interventional, and Treatment
This randomized controlled trial investigates the clinical effectiveness of dry needling in individuals with myofascial temporomandibular disorder (TMD). The study compares dry needling applied to trigger points in the masseter and temporalis muscles with conventional physical therapy. Primary outcomes include changes in pain intensity, and muscle EMG. Given these considerations, this study aims to investigate the clinical acute effectiveness of dry needling applied to the masseter and temporalis muscles in individuals diagnosed with myofascial TMD.
Temporomandibular disorders (TMDs) are a common group of musculoskeletal conditions affecting the jaw joint and surrounding muscles, often characterized by pain, limited mandibular mobility, and muscle tenderness. Among the various subtypes of TMD, myofascial pain is the most prevalent and typically involves the presence of myofascial trigger points (MTrPs) in the masticatory muscles. Dry needling (DN) is a minimally invasive technique that targets MTrPs using monofilament needles to induce a local twitch response and disrupt dysfunctional motor end plate activity.
This single-blinded, randomized controlled trial aims to evaluate the acute clinical effectiveness of DN compared to conventional physical therapy in individuals with myofascial TMD. In our study, 36 participants were randomly assigned to one of two groups: the dry needling group or the sham group, using a randomization process conducted through random.org. The study aimed to examine the acute effects following a single application. A double-blind design was employed, with separate physiotherapists responsible for administering the intervention and conducting the assessments. The study consisted of three stages: pre-intervention assessment, intervention, and post-intervention assessment.
Jaw pain intensity was evaluated at the end of the range of motion using a 100 mm VAS, a tool recognized for its high reliability in musculoskeletal assessments. All participants were asked to indicate their pain level on the VAS, allowing for a subjective quantification of perceived pain intensity
Surface electromyographic (sEMG) activity of the jaw muscles was recorded bilaterally from the anterior temporalis (TA-R, TA-L) and masseter (MM-R, MM-L) muscles using the BioPAK System (version 7.2; BioResearch Associates Inc., Milwaukee, WI, USA).
123 studies on the registry are indexed under Spasm; 7 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 104 interventional studies indexed under Spasm.
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Inclusion Criteria
In the DNG, under aseptic conditions, the needle was inserted into the predetermined trigger point of the masseter muscle using a guide tube. It was then advanced deeply into the muscle tissue and manipulated using a pistoning technique involving approximately ten in-and-out movements without complete withdrawal. The direction of the needle was systematically varied to stimulate adjacent regions of the muscle, maintaining an average insertion rate of one movement per second. Local twitch responses (LTRs) were elicited and monitored throughout the procedure. Upon completion, the needle was withdrawn, and gentle pressure was applied to the insertion site with a sterile cotton pad to prevent bleeding
Procedure: Dry Needling
In the SG, a validated sham needling procedure was simulated. Participants were positioned identically to the DNG and the same type of needle and guide tube were used. However, the safety lock on the needle was left intact, preventing skin penetration. A cotton pad was applied with light pressure to the skin surface, mimicking the procedure used in the DNG. This approach has been previously validated as a reliable sham control in dry needling research
Other: sham needling
Dry Needling
In the SG, a validated sham needling procedure was simulated.
Jaw pain intensity
Jaw pain intensity was evaluated at the end of the range of motion using a 100 mm VAS, a tool recognized for its high reliability in musculoskeletal assessments. All participants were asked to indicate their pain level on the VAS, allowing for a subjective quantification of perceived pain intensity . Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating worse outcomes.
Time frame: Baseline and After 10-minute
Surface electromyographic (sEMG)
Surface electromyographic (sEMG) activity of the jaw muscles was recorded bilaterally from the anterior temporalis (TA-R, TA-L) and masseter (MM-R, MM-L) muscles using the BioPAK System (version 7.2; BioResearch Associates Inc., Milwaukee, WI, USA).
Time frame: Baseline and After 10-minute
Plan to share: No — The individual participant data will not be shared due to privacy and confidentiality concerns and because data sharing is not required for the objectives of this study.
No publications or documents are linked to this record.
Ran from Jul 2025 to primary completion in Aug 2025, 0 months.
Of 24 interventional studies with no phase under Spasm, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's 0 months is below that.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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