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临床试验/NCT06583915
NCT06583915尚未招募不适用

Comparative Study of Dry Needling Vs Transcutaneous Electrical Nerve Stimulation in Management of Patient with Myofascial Pain Dysfunction Syndrome Using Electromyography and Visual Analogue Scale: a Randomized Clinical Trial

Cairo University0 个研究点目标入组 26 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
26
主要终点
Pain

研究概览

简要总结

Myofascial pain dysfunction syndrome (MPDS) is the most common form of temporomandibular disorders. Because of the multifactorial nature of the problem, its management is still not definite. This randomized clinical trial aimed to assess the efficacy of transcutaneous electrical nerve stimulation over dry needling for management of such condition.

详细描述

Myofascial pain syndrome (MPS) is a prevalent affliction among individuals experiencing musculoskeletal pain issues. This condition is characterized by pain originating from the muscle and surrounding fascia. Patients typically exhibit localized pain in a confined region or referred pain with diverse patterns.

Additionally, physical examinations may reveal trigger points on the affected muscles. MPS can be categorized into acute and chronic forms. Acute MPS often resolves spontaneously or with uncomplicated treatments. However, chronic MPS typically has a poorer prognosis, and symptoms may persist for six months or more.

Dry needling involves the insertion of a solid filiform needle into a trigger point without the administration of any substance. Various theories have been put forth to explain the mechanisms by which dry needling alleviates pain . These include the "gate control" theory, modulation of endogenous opioids such as B-endorphin, encephalins, and dynorphins, disruption of central sensitization through activation of Aβ fibers resulting in inhibition of synaptic transmission between Aβ and C fibers and cells of the spinal cord dorsal horn due to their slower impulse conduction, and even placebo effects have been suggested . When a needle is inserted into a trigger point, it may elicit a local twitch response. This reflexive contraction of the trigger point can also facilitate physiological changes, including the reduction of spontaneous electrical activity and the concentration of inflammatory and nociceptive chemicals, ultimately resulting in the relaxation of the trigger point.

Transcutaneous electrical nerve stimulation (TENS) is considered to be a highly secure and cost-effective modality for managing both chronic and acute pain. As per the gate control theory, TENS employs low voltage electrical pulses that are applied to the central nervous system. The modulation of pain perception induced by TENS is attributed to the recruitment of Aβ afferent fibers in the posterior horn of the spinal cord, which prevents the activation of pain conducted in thin fiber. Electrical stimulation effectively inhibits the transmission of painful impulses through the spinal cord and stimulates the release of endogenous opioids by the brain. Its safe, noninvasive, inexpensive and effective method of providing analgesia with reduced potential adverse effects compared to other treatment modalities.

In this research, we aim to evaluate TENS is a suitable treatment for MPDS patients, which would eliminate the need for another treatment modality. The expected benefit in this study is to find the best treatment for MPDS reducing pain, muscle stiffness and limited mouth opening.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients complaining of pain in muscles of mastication lasting for three months or more.
  • •Presence of trigger points in the temporalis, masseter or lateral pterygoid muscle identified by clinical examination and palpation.
  • •Average pain severity of at least 4 on a 10-point scale
  • •Pain in pre-auricular area, or in the ear during rest or function

排除标准

  • •No previous tempro-mandibular joint (TMJ) surgical intervention
  • •Patients with neurological disorders, coagulopathy, vascular disease autoimmune disease (systemic lupus, rheumatoid arthritis), fibromyalgia
  • •Current opioid use
  • •Intake of analgesics, muscle relaxant, anti-inflammatory medications such as NSAID's and benzodiazepines,
  • •Patients with severe trauma or infections in TMJ
  • •Tempro-mandibular dysfunction (TMD) with joint origin (any type of internal derangement)

研究组 & 干预措施

Transcutaneous electrical nerve stimulation

Experimental

Low voltage electrical pulses that are applied to the central nervous system

干预措施: TENS (Procedure)

Dry Needling

Active Comparator

insertion of a solid filiform needle into a trigger point without the administration of any substance

干预措施: Dry Needle (Procedure)

结局指标

主要结局

Pain

时间窗: From enrollment to the end of treatment at 6 months

Using visual analogue scale (VAS) from (1-10) where 1 is the least pain and 10 is the maximum pain

次要结局

  • Muscle stiffness(From enrollment to the end of treatment at 6 months)
  • Limitation in mouth openinig(From enrollment to the end of treatment at 6 months)
  • Sleeping disorder(From enrollment to the end of treatment at 6 months)
  • Anxiety(From enrollment to the end of treatment at 6 months)
  • Patient satisfaction(From enrollment to the end of treatment at 6 months)

研究者

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

Amina amr sayed mohamed salama

Master Degree Student, Department of oral and maxillofacial surgery

Cairo University

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