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临床试验/NCT05993000
NCT05993000已完成不适用

Effect Of Mobilization, Exercise And Music On Frozen Shoulder Patients

Ondokuz Mayıs University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年5月29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
40
试验地点
2
主要终点
Disabilities of the Arm, Shoulder, and Hand

研究概览

简要总结

The goal of this clinical trial is to determine the effect of listening to music during the treatment of frozen shoulder on pain, normal range of motion, functional activity status and quality of life.Upon recruitment, the subjects were randomly assigned to one of four treatment groups: Group 1 received Music + Mobilization + Exercise, Group 2 received Music + Exercise, Group 3 received Mobilization + Exercise, and Group 4 received Exercise only.

详细描述

Forty individuals diagnosed with frozen shoulder were randomly allocated into four distinct treatment groups. Each participant received a total of eighteen treatment sessions, administered three days per week. Pain levels, range of motion of the shoulder joint, functional status, general health condition, and quality of life were measured and recorded for each participant both before and after the treatment.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • idiopathic or primary adhesive capsulitis5,20,32,
  • a diagnosis of stage 2-3,
  • unilateral condition,
  • age between 30 to 65 years,
  • normal findings on radiographs within the previous 12 months,
  • no previous shoulder surgeries to the affected shoulder,
  • no previous manipulations under anesthesia of the affected shoulder,
  • passive joint movements limited to 50-75% of the normal range of motion of the joint, - and no hearing loss.

排除标准

  • have shoulder girdle motor control deficits associated with neurological disorders.

结局指标

主要结局

Disabilities of the Arm, Shoulder, and Hand

时间窗: baseline and 6 weeks

I used this scale to evaluate the participants' upper extremity functions.The questionnaire consists of 30 items that cover various activities related to daily living, work, and recreational activities that involve the use of the upper extremities. Participants rate their ability to perform each activity and the severity of their symptoms on a scale from 1 to 5, where 1 represents "no difficulty" or "no symptoms" and 5 represents "unable to do" or "extremely severe symptoms."A high score means that the patient's condition is poor.

Visual Analog Scale

时间窗: baseline and 6 weeks

The Visual Analog Scale is a psychometric response scale used to measure subjective characteristics or attitudes, and it has been utilized to assess the pain levels of participants.10-cm visual analog scale, ranging from 0 ("no pain") to 10 ("the worst imaginable pain").

Modified Constant Score

时间窗: baseline and 6 weeks

The questionnaire used to measure muscle strength was applied because the participants had shoulder joint range of motion less than 90 degrees before treatment.The Modified Constant Score typically evaluates four main components: Pain ( 0 being no pain and 15 being severe pain),Activities of Daily Living (20 points: This section assesses the patient's ability to perform various activities using the affected shoulder, such as combing hair, putting on a coat, and reaching behind the back), Strength ( The examiner rates the strength on a scale from 0 to 25), Range of Motion (40 points). The total Modified Constant Score is the sum of the points obtained in each of these four components, resulting in a maximum score of 100. Higher scores indicate better shoulder function and range of motion.

Goniometer

时间窗: baseline and 6 weeks

A goniometer was used to measure the participants' shoulder range of motion.

36-Item Short Form Health Survey

时间窗: baseline and 6 weeks

Anket used to assess the overall health status of the participants is the "36-Item Short Form Health Survey" or "SF-36.The SF-36 consists of 36 questions that cover eight health domains: Physical Functioning, Role Limitations due to Physical Health Problems,Bodily Pain,General Health,Vitality, Social Functioning,Role Limitations due to Emotional Problems, Mental Health. Each domain is assessed through multiple questions, and the responses are scored and transformed to create summary scores for each domain. These summary scores can range from 0 to 100, with higher scores indicating better health-related quality of life.

次要结局

  • BMI(Basal Mass Index)(baseline and 6 weeks)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SELMA İŞLER

Physiotherapist

Ondokuz Mayıs University

研究点 (2)

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