Clinical trial NCT06094361: "IONTOPHORESIS vs. PHONOPHORESIS" for Treatment of Subacromial Impingement Syndrome
Official title: "IONTOPHORESIS vs. PHONOPHORESIS": WHICH IS A BEST WAY TO TREAT SUBACROMIAL IMPINGEMENT SYNDROME? A RANDOMIZED STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Keywords: Iontophoresis
Phonophoresis
Pain
Disability
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There were two separate groups in the study. The first group received iontophoresis and the other group received phonophoresis. The effects on treatment outcomes were compared.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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%.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: At the baseline
measure: Visual Analog Scale
timeFrame: Immediately after 10 physiotherapy sessions on consecutive days
Secondary outcomes:
measure: Sociodemographic Data Form
timeFrame: At the baseline
measure: Range of Motion
timeFrame: At the baseline
measure: Range of Motion
timeFrame: Immediately after 10 physiotherapy sessions on consecutive days
measure: Shoulder Disability Questionnaire
timeFrame: At the baseline
measure: Shoulder Disability Questionnaire
timeFrame: Immediately after 10 physiotherapy sessions on consecutive days
measure: Quick-Disabilities of the Arm, Shoulder and Hand Questionnaire
timeFrame: At the baseline
measure: Quick-Disabilities of the Arm, Shoulder and Hand Questionnaire
timeFrame: Immediately after 10 physiotherapy sessions on consecutive days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References: