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临床试验/NCT06116981
NCT06116981已完成不适用

Effects of High-induction Magnetic Field Therapy in Patients With Shoulder Pain

KTO Karatay University2 个研究点 分布在 2 个国家目标入组 36 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
Range of Motion

研究概览

简要总结

High Induction Magnetic Field Therapy is a therapeutic method that uses high-intensity fields (up to 2.5 T) that produce high current density in exposed tissue. While there are studies in the literature on devices with 2.5 T, there is no research on the effect of 4 T. Magnetic field application contributes significantly to the healing process. It is an easier, cheaper, and more comfortable application. The magnetic field has been clinically proven to be safe. It is a practical, non-invasive method to induce cell and tissue modifications, correcting selected pathological conditions through magnetic application. The aim of the study is to investigate whether High Induction Magnetic Field therapy applied in addition to conservative treatment in patients with shoulder pain makes a difference compared to conservative treatment alone.

详细描述

It is planned to include people between the ages of 18-65 in the study. Before the evaluation, written consent will be obtained from the participants and information on their age, gender, weight, height, chronic disease and medication use, presence of previous surgical operations, daily activity frequency, alcohol or cigarette use will be obtained.

Individuals who voluntarily agree to participate in the study and have at least one of the following diagnoses: shoulder impingement syndrome, rotator cuff rupture, and subacromial bursitis will be included in the study. Individuals with a neurological, orthopedic or cardiovascular chronic disease that cannot be controlled with medication, those who are pregnant or suspected of being pregnant, those with a pacemaker, those with implanted ear hearing aids and those with metallic implants will be excluded.

Individuals' shoulder pain levels, normal joint range of motion and daily living activities will be evaluated before and after treatment.

It is planned to include two separate groups in the study: a conservative treatment group and a group that will receive high induction magnetic field therapy in addition to conservative treatment. Within the scope of conservative treatment, ice application, transcutaneous electrical stimulation-TENS, interferential current, stretching and strengthening exercises, and normal joint range of motion exercises will be applied. Conservative treatment will be continued five days a week for a total of four weeks. High induction magnetic field therapy (Salus Talent, 4 T) will be applied in 10 sessions, 10 minutes, with one day intervals within a four-week treatment program.

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
None

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

入选标准

  • Voluntarily agreeing to participate in the research.
  • Being between the ages of 18 and 65
  • Having at least one of the following diagnoses: shoulder impingement syndrome, rotator cuff rupture, and subacromial bursitis.
  • Having the cognitive fitness to perform the surveys and tests to be used during the research.

排除标准

  • Having a chronic disease such as neurological, orthopedic or cardiovascular that cannot be controlled with medication.
  • Not volunteering to participate in the research.
  • Pregnant and suspected pregnancy individuals
  • Individuals with pacemakers
  • Individuals with implantable ear hearing aids
  • Individuals with metallic implants

结局指标

主要结局

Range of Motion

时间窗: baseline and after 4 weeks of treatment

Range of Motion of Shoulder Joint: Shoulder joint flexion (0-180 degrees), abduction (0-180 degrees), external rotation (0-90 degrees) and internal rotation (0-90 degrees) range of motion will be measured with a goniometer. Higher values indicate increased mobility.

Disabilities of the Arm, Shoulder and Hand (DASH)

时间窗: baseline and after 4 weeks of treatment

The DASH is a 30-item patient-reported outcome measure utilized to assess symptoms and function of the entire upper extremity. Total scores range from 0 (minimum) to (100) maximum. The first 30 questions of the survey will be applied. As the score increases, the disability level increases.

Constant Murley Score

时间窗: baseline and after 4 weeks of treatment

It is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free joint range of motion, and 25 points for strength parameters. While pain and daily living activities are evaluated by the patient, joint range of motion and strength are evaluated by the clinician. A higher score corresponds to a higher-quality of function.

Visual analogue scale-VAS

时间窗: baseline and after 4 weeks of treatment

A score between 0 and 10 points is given and used to evaluate pain.

次要结局

未报告次要终点

研究者

发起方
KTO Karatay University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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