跳至主要内容
临床试验/NCT05821985
NCT05821985已完成不适用

Evaluation of the Effect of Dextrose Prolotherapy Versus Dry Needling Therapy for the Treatment of Temporomandibular Joint Anterior Disc Displacement With Reduction (A Randomized Controlled Trial)

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
clicking

研究概览

简要总结

The hypertonic dextrose injection; Prolotherapy is a proliferation injection therapy that aims to trigger a low-grade inflammatory response inside the (TMJ), with the resultant captivation of abundant fibroblasts that regenerate and strengthen the tendinous and ligamentous attachments and stabilize the disc and the fibro-osseous junctions.

On the other hand, dry needling' refers to the insertion of needles without the use of injectate. Dry needling is beneficial for treating a variety of neuromusculoskeletal pain syndromes as it represents a treatment modality for the ligaments and tendons, muscles, subcutaneous fascia, peripheral nerves, and neurovascular bundles. Deep dry needling (DDN) is a technique that utilizes the Intracapsular insertion of dry needles to approach the discal insertion to the lateral pterygoid muscle and the masseteric muscle origin, along the zygomatic bone and arch, aiming to inactivate the muscular trigger points (TPs).

详细描述

The Temporomandibular joint (TMJ) represents the most complex synovial articulation in the human body, with its articular disc enclosed between the articular tubercle's slope and the convexity of the mandibular condyle.

Although the Magnetic resonance interpretation of the normal discal position defines the posterior discal band atop the highest convexity of the mandibular condyle, at a 12 o'clock position, this discal disposal is altered in almost 30% of the population without physical signs. Which rendered the treatment of the discal displacement mainly dependent on alleviating the signs and symptoms rather than restoring the anatomical disc position.

Various non-invasive therapeutic modalities are utilized for relieving the signs and symptoms of anterior discal displacement, including physical therapy, exercises, ischemic compression, heat therapy, acupuncture, dry needling, wet needling injections with different agents, and pharmacological treatments.

Among those, the trigger point injection is an effective modality, with or without the injection of saline or ringer's solutions, hyaluronic acid, corticosteroids, local anesthetics, botulinum toxin, platelet-rich plasma, or hypertonic dextrose The current study aims to design a randomized controlled trial that compares the effect of injecting 12.5 % of dextrose solution intraarticular and into the myofascial trigger points versus the dry needling of the same sites on alleviating the clinical signs and symptoms of (TMJ) disc displacement with reduction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • Patients of both genders with an age group of 18-45 years.
  • Those patients with the radiographic interpretation of temporomandibular joint disc displacement with reduction (MRI) and the clinical signs of pain, limitation of mouth opening, and TMJ clicking.
  • The presence of associated myofascial pain with masseteric trigger points (TPs)

排除标准

  • Any previous temporomandibular joint treatment.
  • Any systemic disease affecting the temporomandibular joint's anatomy, mechanical function, or outcome of the proposed treatment.
  • Those Patients with a history of allergic reactions to any components of the injectable solution

结局指标

主要结局

clicking

时间窗: 8 months

(evident or not)

Interincisal opening

时间窗: 8 months

distance by cm caliber from the between the anterior teeth at the maximal unassisted nonpainful opening of the patient.

Pain threshold

时间窗: 8 months

by using visual analogue scale from 0 to 10 which 10 is the worst pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Nagi Alghandour

Lecturer

Beni-Suef University

研究点 (1)

Loading locations...

相似试验