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临床试验/NCT05062941
NCT05062941已完成不适用

The Effect of High-intensity Laser Therapy on Pain, Functionality, and Quality of Life in Patients With Chronic Shoulder Pain

Marmara University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Change in range of motion from baseline to week 3

研究概览

简要总结

The aim of this study was to investigate the effects of biostimulating, analgesic and noninvasive high intensity laser therapy on pain, functionality and quality of life in patients with chronic shoulder pain. Participants between the ages of 18-75 and without any cognitive, communication and psychiatric problems were included in the study. Patients were randomized into two groups and both received conventional physiotherapy and rehabilitation program for 3 weeks, 5 sessions a week. The treatment program applied was as followed; the control Group (n = 25): conventional physiotherapy and study Group (n = 25): conventional physiotherapy and High-intensity Laser Therapy (HILT). Upper extremity range of motion was evaluated with 'goniometer', pain threshold with 'algometer, muscle strength with 'myometer'; disability status with 'The Disabilities of the Arm, Shoulder and Hand (DASH)'.

详细描述

The aim of this study was to investigate the effects of biostimulating, analgesic and noninvasive high intensity laser therapy on pain, functionality and quality of life in patients with chronic shoulder pain. Participants between the ages of 18-75 and without any cognitive, communication and psychiatric problems were included in the study. Patients were randomized into two groups and both received conventional physiotherapy and rehabilitation program for 3 weeks, 5 sessions a week. The treatment program applied was as followed; the control Group (n = 25): conventional physiotherapy and study Group (n = 25): conventional physiotherapy and High-intensity Laser Therapy (HILT). Upper extremity range of motion was evaluated with 'goniometer', pain threshold with 'algometer, muscle strength with 'myometer'; disability status with 'The Disabilities of the Arm, Shoulder and Hand (DASH)'.

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

入选标准

  • Volunteered to participate in the study,
  • Aged 18-75 years
  • being diagnosed with chronic shoulder pain

排除标准

  • not having sufficient cooperation to follow exercises,
  • having any communication problems or psychiatric problems,
  • having any cardiac or orthopedic discomfort that may prevent the application of evaluation methods.

结局指标

主要结局

Change in range of motion from baseline to week 3

时间窗: 3 weeks

The range of motion of the joints in the upper extremities will be measured using the universal goniometer before and after the treatment.

Change in pain threshold from baseline to week 3

时间窗: 3 weeks

The pain threshold will be measured with a digital algometer device. Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability.

Change in disability of the upper extremity from baseline to week 3

时间窗: 3 weeks

Disability of the upper extremities will be assessed with 'The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire'. It is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time. The 30-item questionnaire includes 21 physical function items, 6 symptom items, and 3 social/role function items. Each 30 items are marked from 1 (No Difficulty) to 5 (Unable). DASH are added to form the raw, or actual, score. A minimum score is 30; a maximum is 150. The range of the scores, therefore-from 30 to 150-equals 120. The raw score is then transformed to a zero-to-100 scale with zero reflecting no disability (good function) and 100 reflecting maximum disability.

Change in muscle strength from baseline to week 3

时间窗: 3 weeks

The muscle strength of shoulder flexion, abduction, adduction, external and internal rotation movements will be evaluated by using the Baseline Push-Pull (New York) dynamometer. Results will be calculated in kg (1 lb = 0.454 kg). The patient's arm will be stabilized and the patient will be asked to show maximum resistance within 2 sec against the dynamometer placed and then hold it for 5 seconds at this position and power. The measurement will be repeated twice and recorded with the average of these two values.

Change in health status from baseline to week 3

时间窗: 3 weeks

In the evaluation of the health status of the individuals the Short Form-36 (SF-36) questionnaire was used. SF-36 is a questionnaire developed to self-evaluate the quality of life. It consists of 36 items in total and has eight sub-parameters. Subscales are scored between 0 and 100, and higher scores indicate higher quality of life.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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