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

NCT ID: NCT06094361

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2016-04-01

Brief Summary

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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

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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%.

Conditions

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Subacromial Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IONTOPHORESIS

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

Group Type EXPERIMENTAL

Iontophoresis Intervention

Intervention Type PROCEDURE

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.

Conventional Therapy

Intervention Type PROCEDURE

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

PHONOPHORESIS

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

Group Type EXPERIMENTAL

Phonophoresis

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Conventional Therapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emre Şenocak

OTHER

Sponsor Role lead

Responsible Party

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Emre Şenocak

Research Assisstant

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Marmara University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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02.06.2015.284

Identifier Type: -

Identifier Source: org_study_id

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