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临床试验/NCT06597643
NCT06597643尚未招募不适用

The Effect of Adding Deep Friction Massage to Eccentric Training Exercises in Lateral Epicondylitis

Cairo University0 个研究点目标入组 46 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
46
主要终点
Visual Analogue Scale

研究概览

简要总结

Background: Lateral epicondylitis (LE) often benefits from eccentric training exercises, but combining them with deep friction massage (DFM) might enhance outcomes.

Objective: To evaluate if adding DFM to eccentric training improves pain, function, wrist extensor strength, and hand grip strength more than eccentric training alone.

Design: A triple-blinded, randomized controlled trial involving 46 participants aged 16-30 with unilateral LE. Participants will be randomly assigned to receive either eccentric training plus sham massage (Control Group) or eccentric training plus DFM (Experimental Group) over 4 weeks.

Methods: Outcomes will be measured using the Visual Analogue Scale (VAS) for pain, the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire for function, a hand-held dynamometer for wrist extensor strength, and a grip dynamometer for hand grip strength.

Blinding: The study is triple-blinded-assessors, statisticians, and participants are unaware of group allocations.

Significance: This study aims to determine if DFM enhances the effectiveness of eccentric training in LE rehabilitation, potentially leading to improved treatment protocols.

详细描述

Background: Lateral epicondylitis (LE), also known as tennis elbow, is an overuse injury of the elbow characterized by pain and functional impairment in the lateral aspect of the elbow. Traditional management strategies often include eccentric training exercises aimed at improving muscle strength and reducing pain. However, the addition of deep friction massage (DFM) to such a regimen might offer additional benefits.

Objective: This study aims to evaluate the impact of combining deep friction massage with eccentric training exercises on pain, functional ability, wrist extensor strength, and hand grip strength in patients with unilateral lateral epicondylitis.

Design: A triple-blinded randomized controlled trial (RCT) will be carried out at the outpatient physical therapy clinic of Pharos University in Alexandria, Egypt. The trial is designed to assess whether the integration of DFM with eccentric training offers superior outcomes compared to eccentric training alone.

Participants: The study will involve 46 patients aged 16 to 30 years, diagnosed with unilateral lateral epicondylitis. Participants will be randomly assigned to one of two groups: Group A (Control) and Group B (Experimental). Inclusion criteria include unilateral elbow pain, a BMI between 18.5 and 29.9, and chronic LE not treated with physical therapy in the past six months. Exclusion criteria include significant injuries or diseases affecting the shoulder, elbow, or wrist, recent local steroid injections, cervical radiculopathy, and neurological impairments.

Interventions:

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)

盲法说明

statistician will be blind to the details of allocation and intervention in each group

入排标准

年龄范围
16 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Both gender male and female
  • Age from 16 to 30
  • Unilateral elbow pain
  • Body mass index ranges from 18.5 to 29.9
  • Non athletic patient
  • Chronic LE don't receive PT for 6 months

排除标准

  • Any injury or disease around the shoulder, elbow and wrist on the affected side
  • Any b local intervention such as injection of steroids 6 month prior to the intervention
  • Cervical radiculopathy
  • History of fracture of radius, ulna and humerus with resultant deformity of the affected extremity
  • Neurological impairments

结局指标

主要结局

Visual Analogue Scale

时间窗: 4 weeks

is used to measure the pain which is represented from (0) grade to (10) grade, with zero means no pain and ten means intolerable pain, The subjects were asked to indicate the level of pain by placing a dash at the appropriate level on the 10 cm horizontal line

次要结局

  • -Disability of the Arm, Shoulder and Hand questionnaire Arabic version(4 weeks)
  • Hand-held Dynamometer(4 weeks)
  • -Jamar grip dynamometer(4 weeks)

研究者

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

Mai Mohamed Abdelkader Abdallah

Director

Cairo University

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