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临床试验/NCT05325255
NCT05325255招募中不适用

Effect of Myofascial Release of Subscapularis Along With Shoulder Mobilization Versus Shoulder Mobilization Alone in Adhesive Capsulitis

Dow University of Health Sciences3 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
3
主要终点
Change from baseline pain intensity on Numeric Pain Rating Scale in scores at 6th session (10 days)

研究概览

简要总结

This randomized control trial aims to compare the effect of myofascial release of subscapularis along with shoulder mobilization VS mobilization alone among patients with adhesive capsulitis. The study will be conducted at physiotherapy outpatient department (OPD) of Sindh Institute of physical medicine and rehabilitation, and Dow University Ojha Campus, Karachi. According to study criteria, 70 patients with sub-acute adhesive capsulitis will be selected through a non-randomized purposive sampling technique by a consultant physician. After taking informed consent, participants will be randomly divided into 2 groups through the sealed envelope method. Both the groups will receive conventional treatment while Group 1 will be given an additional treatment of myofascial release of subscapularis through ischemic compression technique. Total 6 treatment sessions will be provided and assessment will be done at baseline and end of the 6th session.

详细描述

The sample size of 31 per group was determined using planning and specification software (PASS) version 15 software based on two independent sample t-test using 95%confidence interval and 80% power of the test. This sample was raised to 35 per group with 4 patients as drop out per group. Mean and standard deviation will be calculated for the quantitative variables while frequency and percentages will be calculated for qualitative variables. Inter-group comparison at baseline will be calculated using an independent sample t-test. The mean difference between both the techniques in terms of numeric pain rating scale (NPRS), range of motion (ROM), shoulder pain and disability index (SPADI), and pain pressure threshold(PPT) will be determined using Repeated measure 2-way ANOVA.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Patients aged between 40-65 years
  • Diagnosed with sub-acute adhesive capsulitis
  • Pain range of 3 to 8 on NPRS
  • SPADI score of >40
  • Presence of myofascial trigger point in subscapularis muscle

排除标准

  • History of fracture
  • Rheumatoid arthritis
  • Shoulder osteoarthritis
  • Any malignancy
  • Shoulder dislocation
  • Subacute adhesive capsulitis with impingement syndrome

结局指标

主要结局

Change from baseline pain intensity on Numeric Pain Rating Scale in scores at 6th session (10 days)

时间窗: At baseline and after 6 sessions (10 days)

It will be use to assess pain intensity. It will be administered by simply asking the intensity of pain experienced in last 24 hours. The response of 0 represent no pain rather the responses between 1-3, 4-6, and 7-9 represents mild, moderate, and severe pain respectively. While 10 is the worst possible pain ever experienced by the person

Change from baseline joint range of motion on universal goniometer in degrees at 6th session (10 days)

时间窗: At baseline and after 6 sessions (10 days)

It will be assessed by using standard universal goniometer and measured in degrees

change from baseline shoulder disability on Shoulder pain and disability index in percentage at 6th session (10 days)

时间窗: At baseline and after 6 sessions (10 days)

Shoulder pain and disability index is used to assess shoulder disability. It consist of 13 questions i .e. 5 to assess pain and 8 to assess disability. Results will be calculated in percentage and higher results indicate increased disability. lower the percentage better will be the outcome.

Change from baseline pain pressure threshold on algometer in kilogram/centimeter2 at 6th session (10 days)

时间窗: At baseline and after 6 sessions (10 days)

assessed through algometer which provide sustained pressure from 0.05Newton/second to 20 Newton/second. Results will be recorded in kilogram/centimeter2 and higher values indicate decrease sensitivity of myofascial trigger points

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Umama Abbasi

Principle Investigator

Dow University of Health Sciences

研究点 (3)

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