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临床试验/NCT07180225
NCT07180225
已完成
不适用

Manual Therapy Combined With Breathing Exercises in Management of Rotator Cuff Impingement Syndrome

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年2月10日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Istanbul Medipol University Hospital
入组人数
52
试验地点
1
主要终点
Pain evaluation

概览

简要总结

Rotator cuff impingement syndrome is one of the most common causes of shoulder pain and functional limitation, with manual therapy frequently employed in its management. This study aimed to investigate the additional effects of incorporating breathing exercises into manual therapy on pain and function.

详细描述

Rotator cuff impingement syndrome is one of the most common causes of shoulder pain and functional limitation, with manual therapy frequently employed in its management. This study aimed to investigate the additional effects of incorporating breathing exercises into manual therapy on pain and function. The study was conducted with fifty-two individuals aged 18-65 diagnosed with rotator cuff impingement syndrome. Individuals who met the inclusion criteria were randomly and equally assigned to two groups. Participants in the control group received the cold pack, TENS, and conventional exercise program. Participants in the intervention group received manual therapy combined with respiratory exercises in addition to this therapy program. All participants received therapy three times a week for a total of six weeks. The Visual Analog Scale (VAS) and Shoulder Pain and Disability Index (SPADI), shoulder range of motion (ROM) assessments, and a spirometer were used for evaluation.

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)

盲法说明

PARTICIPANTS ARE MASKED

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

  • being between 18 and 65 years of age;
  • the presence of at least one of the following clinical findings: positive Neer Impingement Test, positive Hawkins-Kennedy Impingement test, or painful arc during active abduction or flexion
  • experiencing pain in at least one of the resisted tests for internal rotation, external rotation, abduction, or flexion
  • being able to participate in the face-to-face treatment program consisting of a total of 18 sessions

排除标准

  • a history of upper extremity fracture; undergoing shoulder surgery on the affected side within the past 12 months
  • significant shoulder weakness or loss of active shoulder function; the presence of systemic musculoskeletal disorders
  • symptom reproduction during active or passive cervical movements; the presence of consciousness disorders, cognitive impairments; and having any diagnosed cardiovascular disease

结局指标

主要结局

Pain evaluation

时间窗: Baseline and 6 weeks

Pain intensity was assesed with visual anaolg scale (VAS) that is a tool commonly used to assess the intensity of musculoskeletal pain. The VAS was used to evaluate the level of shoulder pain experienced by participants at rest, and during activity. Participants were asked to rate their pain intensity on a scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain." The participants' responses were recorded in the case report forms

Disability

时间窗: Baseline and 6 weeks

Shoulder Pain and Disability Index (SPADI) is a self-reported, shoulder specific questionnaire developed to assess pain intensity and disability levels in individuals with musculoskeletal shoulder pain.The disability subscale includes eight items, where patients rate the difficulty, they experienced while performing daily activities in the past week, using a scale from 0 (no difficulty) to 10 (so difficult that assistance is required). The total SPADI score was calculated by converting the total raw score into a percentage. The final score ranges from 0 to 100, with higher scores indicating greater levels of pain and disability

Range of motion evaluation

时间窗: Baseline and 6 weeks

A universal goniometer was used to measure the shoulder joint's ROM in flexion, extension, abduction, internal rotation, and external rotation. Measurements were recorded in degrees. Each movement was performed three times, and the average of these three measurements was used for analysis. After each measurement, the participant returned their arm to the neutral position before the next repetition. The normal ROM values for the shoulder joint are as follows: 0-180° for flexion and abduction, 0-45° for extension and adduction, and 0-90° for internal and external rotation

Pulmonary system evaluation

时间窗: Baseline and 6 weeks

A firstMed SP-10 electronic handheld spirometer was used to evaluate respiratory function. Each participant was instructed to place a disposable mouthpiece between their lips and teeth, ensuring no air escaped. They were then encouraged to perform a rapid and deep inspiration followed immediately by a forceful and complete expiration. Participants were expected to exhale for at least 6 seconds. The test was terminated once adequate expiration was achieved. Among at least three properly performed consecutive trials, the highest value was recorded

次要结局

未报告次要终点

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

merve yilmaz menek

Assoc. Prof

Istanbul Medipol University Hospital

研究点 (1)

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