Subacromial Impingement SyndromeNCT06094361
"IONTOPHORESIS vs. PHONOPHORESIS" for Treatment of Subacromial Impingement Syndrome
A study testing Iontophoresis Intervention, Phonophoresis and Conventional Therapy in people with Subacromial Impingement Syndrome, run by Emre Şenocak at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Iontophoresis Intervention, Phonophoresis and Conventional Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2015to 1 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Stage I-II SIS
- The ages between 18 and 65 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
Read the 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%.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Iontophoresis Intervention, Phonophoresis, Conventional Therapy
- Keywords
- Iontophoresis, Phonophoresis, Pain, Disability
- Medical subject headings
- Shoulder Impingement Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iontophoresis InterventionProcedure or surgery
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.
PhonophoresisProcedure or surgery
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 TherapyProcedure or surgery
All groups received a treatment program consisting of hot pack, Transcutaneous Electrical Nerve Stimulation and Shoulder girdle exercises for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| IONTOPHORESIS | Experimental | The group that received 75 mg diclofenac sodium with Chattanooga Physio device. Receives: Procedure: Iontophoresis Intervention; Procedure: Conventional Therapy |
| PHONOPHORESIS | Experimental | It is a treatment performed by applying 75 mg of 1% diclofenac sodium gel to the intervention area with the Chattanooga ultrasound device. Receives: Procedure: Phonophoresis; Procedure: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after 10 physiotherapy sessions on consecutive days
Secondary outcomes (7)
Sociodemographic Data Form
It is a form containing the descriptive characteristics of the patients.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At the baseline
Shoulder Disability Questionnaire
This scale is a sixteen-item scale that assesses disability in individuals with shoulder complaints
Measured: 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.
Measured: 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.
Measured: Immediately after 10 physiotherapy sessions on consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jun 2015
- Primary completion1 Nov 2015
- Study completion1 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emre Şenocak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre Şenocak, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094361
- Sponsor's protocol ID
- 02.06.2015.284
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "IONTOPHORESIS vs. PHONOPHORESIS": WHICH IS A BEST WAY TO TREAT SUBACROMIAL IMPINGEMENT SYNDROME? A RANDOMIZED STUDY
- ClinicalTrials.gov ID
- NCT06094361
- Acronym / sponsor ID
- 02.06.2015.284
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Iontophoresis, Phonophoresis, Pain, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Emre ŞenocakUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Nov 2015 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| IONTOPHORESIS | Experimental | Procedure: Iontophoresis Intervention, Procedure: Conventional TherapyThe group that received 75 mg diclofenac sodium with Chattanooga Physio device. |
| PHONOPHORESIS | Experimental | Procedure: Phonophoresis, Procedure: Conventional TherapyIt is a treatment performed by applying 75 mg of 1% diclofenac sodium gel to the intervention area with the Chattanooga ultrasound device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with Stage I-II SIS
- The ages between 18 and 65 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iontophoresis InterventionIontophoresis 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 or surgery | IONTOPHORESIS |
| PhonophoresisPhonophoresis 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. | Procedure or surgery | PHONOPHORESIS |
| Conventional TherapyAll groups received a treatment program consisting of hot pack, Transcutaneous Electrical Nerve Stimulation and Shoulder girdle exercises for 30 minutes. | Procedure or surgery | IONTOPHORESIS, PHONOPHORESIS |
Primary outcome
Visual Analog Scale
Time frame: At the baseline
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
Time frame: 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.
7 secondary outcomes
Sociodemographic Data Form
Time frame: At the baseline
Range of Motion
Time frame: At the baseline
Range of Motion
Time frame: Immediately after 10 physiotherapy sessions on consecutive days
Shoulder Disability Questionnaire
Time frame: At the baseline
Shoulder Disability Questionnaire
Time frame: Immediately after 10 physiotherapy sessions on consecutive days
Quick-Disabilities of the Arm, Shoulder and Hand Questionnaire
Time frame: At the baseline
Quick-Disabilities of the Arm, Shoulder and Hand Questionnaire
Time frame: Immediately after 10 physiotherapy sessions on consecutive days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iontophoresis Intervention, Phonophoresis and Conventional Therapy in people with Subacromial Impingement Syndrome, run by Emre Şenocak at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: At the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.