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临床试验/NCT06094361
NCT06094361已完成不适用

"IONTOPHORESIS vs. PHONOPHORESIS": WHICH IS A BEST WAY TO TREAT SUBACROMIAL IMPINGEMENT SYNDROME? A RANDOMIZED STUDY

Emre Şenocak2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2015年6月1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
43
试验地点
2
主要终点
Visual Analog Scale

研究概览

简要总结

The aim of this study was to compare the effects of iontophoresis and phonophoresis applications added to conventional treatment on pain, range of motion, disability, and functional status in the shoulder region in patients with subacromial impingement syndrome.

详细描述

Randomization: Forty-seven patients were assessed, and 43 completed the study in this randomized trial. The participants were divided into two groups (Iontophoresis:22 and Phonophoresis:21) using the online randomization software (www.randomizer.org). All patients gave written informed consent after being verbally informed about the study.

Assessment Period: Assessments were conducted twice, at the start and after completion of the 10-session treatment program.

Session Period: All treatment programs were delivered five days per week for two weeks. The total number of sessions was ten.

Analysis: The statistical analysis was performed using version 21 of the Statistical Package for the Social Sciences (SPSS).To verify normal distribution, the Shapiro-Wilk test and histogram curves were utilized. Descriptive statistics for parametric variables included mean, standard deviation, and percentage. Since the data exhibited normal distribution, independent sample T-tests were used for group comparison while paired sample T-tests were used to detect changes within the group. The significance level of p<0.05 was deemed acceptable for all analyses. For variables with nominal assessments, data were analyzed utilizing Yates Continuity Correction and Fisher's exact chi-square test.

The post hoc power of the study was calculated using Gpower 3.1.9.1 software. The resting VAS scores was taken as reference. In this context, Cohen's effect size was calculated as 1.00. When the alpha error was accepted as 5%, and effect size was 1.00, the post hoc power was found to be 94.27%.

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
None

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

  • Patients diagnosed with Stage I-II SIS
  • The ages between 18 and 65 years

排除标准

  • Having underwent shoulder surgery,
  • Participated in a shoulder-related treatment program within the previous six months,
  • Failed to adhere to the treatment program by 70% or more

结局指标

主要结局

Visual Analog Scale

时间窗: Immediately after 10 physiotherapy sessions on consecutive days

This scale assess the pain of the patients. The scale is scored from 0-10, with 0 indicating no pain and 10 indicating intolerable pain.

次要结局

  • Quick-Disabilities of the Arm, Shoulder and Hand Questionnaire(Immediately after 10 physiotherapy sessions on consecutive days)
  • Shoulder Disability Questionnaire(Immediately after 10 physiotherapy sessions on consecutive days)
  • Sociodemographic Data Form(At the baseline)
  • Range of Motion(Immediately after 10 physiotherapy sessions on consecutive days)

研究者

发起方
Emre Şenocak
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emre Şenocak

Research Assisstant

Marmara University

研究点 (2)

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