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临床试验/NCT07704411
NCT07704411已完成不适用

The Effect of Osteopathic Visceral Manipulation on Pain, Mobility and Functional Disability in Patients With Right Shoulder Adhesive Capsulitis

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年1月10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
56
试验地点
1
主要终点
Pain (VAS)

研究概览

简要总结

The aim of this study was to evaluate the effects of adding osteopathic visceral manipulation (OVM) to a standard physical therapy program on pain, functional disability, and range of motion (ROM) in patients diagnosed with right shoulder adhesive capsulitis (AC). A total of 49 patients aged between 40 and 65 years who were diagnosed with right shoulder AC were included in the study. Randomized patients received a standard physical therapy program for three weeks, consisting of 15 sessions (5 days per week) in both treatment groups. The standard program included hot pack application to the shoulder region for 20 min, conventional transcutaneous electrical nerve stimulation (TENS) for 20 min, and ultrasound therapy at 1.5 W/cm² for 10 min. In addition to the standard physical therapy program, Group 1 (n=25) received OVM once weekly, while Group 2 (n=24) received sham OVM once weekly. Pain was evaluated using the Visual Analog Scale (VAS), while functional disability was evaluated using the Shoulder Pain and Disability Index (SPDI). The ROM values were also recorded.

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

入选标准

  • Age between 18 and 65 years
  • Presence of pain originating from the right shoulder region persisting for at least 6 weeks
  • Availability of two-view shoulder radiographs obtained prior to the study to exclude causes of shoulder pain other than AC
  • No local corticosteroid injection for shoulder pain within the previous 6 months
  • No physical therapy administered for shoulder pain within the previous 6 months
  • No use of non-steroidal anti-inflammatory drugs (NSAIDs) during the study period
  • Availability of laboratory assessments including:
  • Complete blood count (CBC)
  • Erythrocyte sedimentation rate (ESR)
  • Liver function tests (AST, ALT)
  • C-reactive protein (CRP)
  • Pain intensity score of at least 4 cm on the Visual Analog Scale (VAS, 0-10 cm)

排除标准

  • History of shoulder fracture on the affected side
  • Prior shoulder surgery
  • History of traumatic shoulder instability (subluxation or dislocation)
  • History of shoulder or visceral organ surgery within the past 6 months
  • History of systemic or inflammatory disease or malignancy
  • Presence of metabolic or endocrine bone disease
  • Pregnancy
  • Neurological disorders affecting upper extremity function
  • Psychiatric disorders that could interfere with treatment compliance or symptom evaluation
  • Use of antiplatelet medication
  • Previous osteopathic treatment

结局指标

主要结局

Pain (VAS)

时间窗: From enrollment to the end of treatment at 4 weeks

次要结局

  • Active shoulder ROM for abduction, flexion, internal rotation, and external rotation(From enrollment to the end of treatment at 4 weeks)
  • Shoulder Pain and Disability Index (SPADI)(From enrollment to the end of treatment at 4 weeks)

研究者

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

Bilinç Doğruöz Karatekin

Associate Professor

Istanbul Medeniyet University

研究点 (1)

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