- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07123883
- Original Trial
Dry Needling for Temporomandibular Disorder (DN-TMD)
Dry Needle Treatment for Acute Temporomandibular Disorders (TMD): A Clinical Perspective
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34403
- Faculty of Dentistry, Atlas University
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Kagithane
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Istanbul, Kagithane, Turkey (Türkiye), 34403
- Istanbul Atlas University, Faculty of Dentistry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Patients aged between 18 and 45 years presenting with complaints of jaw pain to the Department of Dentistry at A University.
- Diagnosed with myofascial pain associated with temporomandibular dysfunction by a dentist, based on the Axis I criteria of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- Jaw pain persisting for at least three months.
- Pain elicited upon palpation of the masseter and/or temporalis muscles.
- Presence of clicking or crepitus in the temporomandibular joint during mandibular movements.
- Self-reported jaw muscle fatigue or stiffness, particularly upon awakening. Exclusion Criteria
- History of any confirmed or suspected inflammatory or neurological condition.
- Presence of any oral or dental infection.
- Any cognitive or communication impairment affecting data collection.
- History of head or facial trauma.
- Allergy to metals.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dry Needling Group (DNG)
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
|
Dry Needling
|
|
Sham Comparator: Sham Group (SG)
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
|
In the SG, a validated sham needling procedure was simulated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jaw pain intensity
Time Frame: Baseline and After 10-minute
|
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.
|
Baseline and After 10-minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surface electromyographic (sEMG)
Time Frame: Baseline and After 10-minute
|
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).
|
Baseline and After 10-minute
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Joint Diseases
- Jaw Diseases
- Mandibular Diseases
- Craniomandibular Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Temporomandibular Joint Disorders
- Spasm
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Dry Needling
Other Study ID Numbers
- Atlas E-22686390-050.99-72665 (Other Grant/Funding Number: Atlas University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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