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临床试验/NCT07123883
NCT07123883已完成不适用

Dry Needle Treatment for Acute Temporomandibular Disorders (TMD): A Clinical Perspective

Atlas University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Jaw pain intensity

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Dry Needling Group (DNG)

Experimental

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

干预措施: Dry Needling (Procedure)

Sham Group (SG)

Sham Comparator

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

干预措施: sham needling (Other)

结局指标

主要结局

Jaw pain intensity

时间窗: 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.

次要结局

  • Surface electromyographic (sEMG)(Baseline and After 10-minute)

研究者

发起方
Atlas University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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