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

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

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.

Study Overview

• Status: Completed
• Conditions: Subacromial Impingement Syndrome
• Intervention / Treatment: Procedure: Iontophoresis Intervention; Procedure: Conventional Therapy; Procedure: Phonophoresis

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34083
    • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IONTOPHORESIS; The group that received 75 mg diclofenac sodium with Chattanooga Physio device.	Procedure: Iontophoresis Intervention; Iontophoresis was applied with a Chattanooga Physio (DJO Global, Herentals, Belgium) brand device. The galvanic current mode was selected for the intervention. Intervention area was cleaned to prevent irritation and active electrode pad (cathode-5 cm2) was immersed in 75 mg diclofenac sodium solution. The current intensity of the application for 10 minutes was 0.1-0.2 mA/cm2.; Procedure: Conventional Therapy; All groups received a treatment program consisting of hot pack, Transcutaneous Electrical Nerve Stimulation and Shoulder girdle exercises for 30 minutes.
Experimental: PHONOPHORESIS; It is a treatment performed by applying 75 mg of 1% diclofenac sodium gel to the intervention area with the Chattanooga ultrasound device.	Procedure: Conventional Therapy; All groups received a treatment program consisting of hot pack, Transcutaneous Electrical Nerve Stimulation and Shoulder girdle exercises for 30 minutes.; Procedure: Phonophoresis; Phonophoresis was performed with a Chattanooga brand ultrasound device (Chattanooga, Intelect Legend Ultrasound, TN, USA). 75 mg gel containing 1% diclofenac sodium was applied to the shoulder area. The ultrasound was conducted continuously for 6 minutes with frequency of 1 MHz and an intensity of 1.5 watts/cm2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	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.	At the baseline
Visual Analog Scale	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.	Immediately after 10 physiotherapy sessions on consecutive days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic Data Form	It is a form containing the descriptive characteristics of the patients.	At the baseline
Range of Motion	The angular values of flexion, extension, abduction, internal and external rotation performed actively by the patients were examined with a universal goniometer.	At the baseline
Range of Motion	The angular values of flexion, extension, abduction, internal and external rotation performed actively by the patients were examined with a universal goniometer.	Immediately after 10 physiotherapy sessions on consecutive days
Shoulder Disability Questionnaire	This scale is a sixteen-item scale that assesses disability in individuals with shoulder complaints	At the baseline
Shoulder Disability Questionnaire	This scale is a sixteen-item scale that assesses disability in individuals with shoulder complaints	Immediately after 10 physiotherapy sessions on consecutive days
Quick-Disabilities of the Arm, Shoulder and Hand Questionnaire	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.	At the baseline
Quick-Disabilities of the Arm, Shoulder and Hand Questionnaire	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.	Immediately after 10 physiotherapy sessions on consecutive days

Collaborators and Investigators

• Sponsor: Emre Şenocak

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Disability; Iontophoresis; Phonophoresis
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: 02.06.2015.284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No