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

Subacromial Impingement Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06094361
• Other study ID #: 02.06.2015.284
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: April 1, 2016

Study information

• Verified date: October 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 1, 2016
• Est. primary completion date: November 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome
• Syndrome

Intervention

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.
• 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.
• Conventional Therapy
All groups received a treatment program consisting of hot pack, Transcutaneous Electrical Nerve Stimulation and Shoulder girdle exercises for 30 minutes.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Emre Senocak

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Sociodemographic Data Form	It is a form containing the descriptive characteristics of the patients.	At the baseline
Secondary	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
Secondary	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
Secondary	Shoulder Disability Questionnaire	This scale is a sixteen-item scale that assesses disability in individuals with shoulder complaints	At the baseline
Secondary	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
Secondary	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
Secondary	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