跳至主要内容
临床试验/CTRI/2025/12/099699
CTRI/2025/12/099699尚未招募Phase 3 4

Comparative efficacy of Therapeutic Ultrasound versus Phonophoresis with Permeation-Enhanced Diclofenac-Tizanidine Gel in Myofascial Pain Dysfunction Syndrome:A Randomized Controlled Clinical Study

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月15日最近更新:
适应症
相关药物

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Pain Intensity measured using Visual analog scale

研究概览

简要总结

Background: Myofascial Pain Dysfunction Syndrome (MPDS) is a common musculoskeletal condition characterized by muscle pain, trigger points, and functional limitation. Physical therapy modalities such as therapeutic ultrasound and phonophoresis are widely used to relieve pain and inflammation. However, evidence comparing their relative efficacy, especially with permeation-enhanced diclofenac–tizanidine gel, remains limited, warranting comparative clinical evaluation.

Aims: To compare the efficacy of therapeutic ultrasound versus phonophoresis with permeation-enhanced diclofenac–tizanidine gel in reducing pain and improving function in patients with Myofascial Pain Dysfunction Syndrome.

Methodology: A randomized parallel-group active-controlled clinical trial was conducted on patients diagnosed with Myofascial Pain Dysfunction Syndrome. Participants were randomly allocated to receive either therapeutic ultrasound or phonophoresis with permeation-enhanced diclofenac–tizanidine gel. Pain intensity and functional outcomes were assessed pre- and post-intervention using standardized clinical scales.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • •Pain in preauricular region
  • •Pain on palpation of masticatory muscles
  • •Presence of joint sounds clicking
  • •Restricted mouth opening
  • •No clinical, radiographic or biochemical evidence of organic joint disease.

排除标准

  • •1.Pregnant or lactating women 2.Patient with pacemakers 3.Known Allergy to Diclofenac Tizanidine 4.Pain of Odontogenic origin 5.Neuralgia or neuromuscular disorder 6.Currently on anti-inflammatory, muscle relaxants analgesic medication 7.Intra-articular TMJ disorders 8.Jaw tumors 9.History of trauma.

结局指标

主要结局

Pain Intensity measured using Visual analog scale

时间窗: 2 weeks interval

次要结局

  • Maximum mouth opening measured using Jaw Functional Limitation Scale(2 weeks interval)

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Sakshi Ramswarup Somani

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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