"IONTOPHORESIS vs. PHONOPHORESIS" for Treatment of Subacromial Impingement Syndrome

Not Applicable

Completed

• Conditions: Subacromial Impingement Syndrome
• Interventions: Procedure: Phonophoresis; Procedure: Iontophoresis Intervention; Procedure: Conventional Therapy

• Registration Number: NCT06094361
• Lead Sponsor: Emre Şenocak

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%.

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2015-11-01
• Study Completion: 2016-04-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PHONOPHORESIS	Phonophoresis	It is a treatment performed by applying 75 mg of 1% diclofenac sodium gel to the intervention area with the Chattanooga ultrasound device.
PHONOPHORESIS	Conventional Therapy	It is a treatment performed by applying 75 mg of 1% diclofenac sodium gel to the intervention area with the Chattanooga ultrasound device.
IONTOPHORESIS	Iontophoresis Intervention	The group that received 75 mg diclofenac sodium with Chattanooga Physio device.
IONTOPHORESIS	Conventional Therapy	The group that received 75 mg diclofenac sodium with Chattanooga Physio device.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	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.

Secondary Outcome Measures

Name	Time	Method
Quick-Disabilities of the Arm, Shoulder and Hand Questionnaire	Immediately after 10 physiotherapy sessions on consecutive days	In the scale, the functional status of individuals with shoulder pathology is questioned during their daily activities, and it is an assessment form filled by the patients themselves.
Shoulder Disability Questionnaire	Immediately after 10 physiotherapy sessions on consecutive days	This scale is a sixteen-item scale that assesses disability in individuals with shoulder complaints
Sociodemographic Data Form	At the baseline	It is a form containing the descriptive characteristics of the patients.
Range of Motion	Immediately after 10 physiotherapy sessions on consecutive days	The angular values of flexion, extension, abduction, internal and external rotation performed actively by the patients were examined with a universal goniometer.

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey