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

Primary Purpose

Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Iontophoresis Intervention
Phonophoresis
Conventional Therapy
Sponsored by
Emre Şenocak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring Iontophoresis, Phonophoresis, Pain, Disability

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marmara University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IONTOPHORESIS

PHONOPHORESIS

Arm Description

The group that received 75 mg diclofenac sodium with Chattanooga Physio device.

It is a treatment performed by applying 75 mg of 1% diclofenac sodium gel to the intervention area with the Chattanooga ultrasound device.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Sociodemographic Data Form
It is a form containing the descriptive characteristics of the patients.
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.
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.
Shoulder Disability Questionnaire
This scale is a sixteen-item scale that assesses disability in individuals with shoulder complaints
Shoulder Disability Questionnaire
This scale is a sixteen-item scale that assesses disability in individuals with shoulder complaints
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.
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.

Full Information

First Posted
October 16, 2023
Last Updated
October 18, 2023
Sponsor
Emre Şenocak
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1. Study Identification

Unique Protocol Identification Number
NCT06094361
Brief Title
"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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
November 1, 2015 (Actual)
Study Completion Date
April 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emre Şenocak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
Iontophoresis, Phonophoresis, Pain, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IONTOPHORESIS
Arm Type
Experimental
Arm Description
The group that received 75 mg diclofenac sodium with Chattanooga Physio device.
Arm Title
PHONOPHORESIS
Arm Type
Experimental
Arm Description
It is a treatment performed by applying 75 mg of 1% diclofenac sodium gel to the intervention area with the Chattanooga ultrasound device.
Intervention Type
Procedure
Intervention Name(s)
Iontophoresis Intervention
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Phonophoresis
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional Therapy
Intervention Description
All groups received a treatment program consisting of hot pack, Transcutaneous Electrical Nerve Stimulation and Shoulder girdle exercises for 30 minutes.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
At the baseline
Title
Visual Analog Scale
Description
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.
Time Frame
Immediately after 10 physiotherapy sessions on consecutive days
Secondary Outcome Measure Information:
Title
Sociodemographic Data Form
Description
It is a form containing the descriptive characteristics of the patients.
Time Frame
At the baseline
Title
Range of Motion
Description
The angular values of flexion, extension, abduction, internal and external rotation performed actively by the patients were examined with a universal goniometer.
Time Frame
At the baseline
Title
Range of Motion
Description
The angular values of flexion, extension, abduction, internal and external rotation performed actively by the patients were examined with a universal goniometer.
Time Frame
Immediately after 10 physiotherapy sessions on consecutive days
Title
Shoulder Disability Questionnaire
Description
This scale is a sixteen-item scale that assesses disability in individuals with shoulder complaints
Time Frame
At the baseline
Title
Shoulder Disability Questionnaire
Description
This scale is a sixteen-item scale that assesses disability in individuals with shoulder complaints
Time Frame
Immediately after 10 physiotherapy sessions on consecutive days
Title
Quick-Disabilities of the Arm, Shoulder and Hand Questionnaire
Description
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.
Time Frame
At the baseline
Title
Quick-Disabilities of the Arm, Shoulder and Hand Questionnaire
Description
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.
Time Frame
Immediately after 10 physiotherapy sessions on consecutive days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34083
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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