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临床试验/NCT06965985
NCT06965985招募中不适用

Comparison of the Effectiveness of Mulligan Mobilization and Myofascial Release Technique in Patients With Lateral Epicondylitis

Konya Beyhekim Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年1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
招募中
发起方
入组人数
114
试验地点
1
主要终点
VAS pain (0-10)

研究概览

简要总结

Lateral epicondylitis (LE), recognized as one of the most prevalent causes of elbow pain, has an estimated incidence ranging from 1% to 3%. It most commonly presents in individuals between the ages of 40 and 50 and tends to affect the dominant limb more frequently. In the adult population, LE is the leading cause of lateral elbow pain.

To date, more than 40 different treatment modalities have been described for the management of LE, primarily aiming to alleviate pain and enhance functional outcomes.

However, a universally accepted standard treatment has yet to be established. The objective of this thesis is to compare the clinical effectiveness of the Mulligan mobilization technique and the myofascial release technique-both commonly utilized in the treatment of LE-through a prospective clinical study.

详细描述

The study is designed as a prospective, case-control, hospital-based investigation. A total of 114 patients between the ages of 18 and 65, presenting to our clinic with elbow pain and diagnosed with lateral epicondylitis (LE) based on physical examination findings-including tenderness upon palpation of the lateral epicondyle, pain during resisted wrist extension, and discomfort during stretching of the wrist extensors-will be included in the study. All participants must have experienced elbow pain for at least three months. The diagnosis of LE will be established according to clinical criteria. Specifically, LE will be diagnosed if pain is elicited upon resisted wrist extension, stretching of the wrist extensor muscles, and palpation over the lateral epicondyle of the humerus.

Participants will be fully informed about the procedure, and written informed consent will be obtained.

The study will be conducted in accordance with the principles outlined in the Declaration of Helsinki.

A comprehensive medical history will be obtained from all participants, along with a detailed physical examination.

Sociodemographic and clinical data-including age, sex, height, weight, education level, employment status, and income level-will be collected through standardized questionnaires.A total of 114 patients diagnosed with lateral epicondylitis (LE) will be randomly assigned into three groups.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged between 18 and 65 years
  • •Diagnosed with unilateral lateral epicondylitis (LE)

排除标准

  • •Younger than 18 or older than 65 years
  • •Communication difficulties
  • •History of injection, surgery, or physical therapy in the elbow region within the past 6 months
  • •Pain originating from the cervical spine (e.g., radiculopathy, spinal stenosis), shoulder problems, or other elbow pathologies unrelated to LE
  • •History of elbow osteoarthritis or previous elbow fracture
  • •History of polyneuropathy
  • •Uncontrolled systemic diseases (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic disorders)
  • •Uncontrolled systemic endocrine disorders (e.g., diabetes mellitus, hyperthyroidism)
  • •History of major psychiatric disorders
  • •History of rheumatic diseases such as fibromyalgia, polymyalgia rheumatica, ankylosing spondylitis, or rheumatoid arthritis
  • •Presence of bleeding disorders or use of anticoagulant medications
  • •Neurological deficits
  • •Posterior interosseous nerve (PIN) syndrome
  • •Current or past use of wrist resting splints or elbow braces

研究组 & 干预措施

Mulligan mobilization techniqu

Experimental

Will receive Mulligan mobilization therapy three times per week for four weeks (a total of 12 sessions), along with a home exercise program

干预措施: Mulligan mobilization therapy (Other)

Myofascial release therapy

Experimental

will receive myofascial release therapy three times per week for four weeks (a total of 12 sessions), in combination with a home exercise program.

干预措施: Myofascial release therapy (Other)

Exercise Therapy

Active Comparator

Will follow only the home exercise program, three times per week for four weeks (12 sessions total).

干预措施: Exercise Therapy (Other)

结局指标

主要结局

VAS pain (0-10)

时间窗: baseline, week 4 and week 8

0 no pain; 10 unbearable/max. pain

grip strength

时间窗: baseline, week 4 and week 8

using a Jamar® dynamometer (in kilograms)

次要结局

  • The Disabilities of the Arm, Shoulder, and Hand (DASH)(baseline, week 4 and week 8)
  • Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)(baseline, week 4 and week 8)
  • The Short Form-36 (SF-36) quality of life index(baseline, week 4 and week 8)
  • Patient satisfaction/benefit scale (The Roles and Maudsley score)(week 4 and week 8)

研究者

发起方
Konya Beyhekim Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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