The Effect of Phonophoresis in Subacromial Impingement Syndrome.

July 27, 2021 updated by: Volkan Deniz, PT, Cukurova University

Phonophoresis Therapy in Subacromial Impingement Syndrome: Comparing of Pulsed Mode Ultrasound Phonophoresis and Continuous Mode Ultrasound Phonophoresis.

Subacromial impingement syndrome (SIS) is a dysfunction caused by an impingement of the rotator cuff tendon between the head of the humerus and the acromion as a result of changes in the subacromial space. The patients' symptoms, such as pain, limited joint mobility and reduced strength, may lead to a diagnosis of SIS. The conservative treatment of individuals with SIS is includes analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), steroid injections and physiotherapy. Ultrasound therapy is one of the common physiotherapy applications for SIS, but its effectiveness is controversial. Phonophoresis is a combination of ultrasound therapy and medical therapy. In phonophoresis, a medicine in gel form is used as a transmitter with ultrasound instead of the aquatic conductor gel. It was hypothesized that ultrasound waves favoring the penetration of an anti-inflammatory drug would lead to an improved response to the treatment of SIS. However, the effectiveness of ultrasound modes (pulsed or continuous) can be used in phonophoresis is debatable. The purpose of this study is to determine the effect of ultrasound therapy, pulsed mode ultrasound and continuous mode ultrasound phonophoresis in patients with SIS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06560
        • Volkan Deniz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • to be diagnosed as shoulder impingement syndrome,
  • shoulder pain for at least one month,
  • VAS score over 40mm.

Exclusion Criteria:

  • grade III supraspinatus tendon injury,
  • major shoulder trauma,
  • diabetes mellitus,
  • hipotiroidizm,
  • adhesive capsulitis,
  • cardiac pacemaker
  • physical therapy or local injection to the shoulder at last six month
  • serious cervical pathologies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: pulsed mode phonophoresis group
Phonophoresis therapy with pulsed mode ultrasound.
Device: phonophoresis therapy with pulsed mode ultrasound
phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks
Experimental: continuous mode phonophoresis group
Phonophoresis therapy with continuous mode ultrasound.
Device: phonophoresis therapy with continuous mode ultrasound
phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks
Sham Comparator: sham group
Sham ultrasound
Device: sham ultrasound
sham ultrasound therapy, five days a week for three weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Baseline, Change from baseline pain scores at three weeks, Change from baseline pain scores at three months
The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Baseline, Change from baseline pain scores at three weeks, Change from baseline pain scores at three months
The Shortened version of Disability of the Arm, Shoulder, and Hand
Time Frame: Baseline, Change from baseline shoulder pain and function scores at three weeks, Change from baseline shoulder pain and function at three months
Disability of the Arm, Shoulder, and Hand (DASH) was designed to describe disability experienced by patients with any musculoskeletal condition of the upper extremity and to monitor change in symptoms and upper limb function over time. The DASH questionnaire has been validated in patients with upper extremity musculoskeletal disorders such as rheumatoid arthritis and shoulder impingement syndrome. The Quick-DASH is a shortened version of the DASH
Baseline, Change from baseline shoulder pain and function scores at three weeks, Change from baseline shoulder pain and function at three months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nottingham Health Profile
Time Frame: Baseline, Change from baseline quality of life scores at three weeks, Change from baseline quality of life scores at three months
Nottingham Health Profile (NHP) evaluates emotional, social, and physical health problems perceived by the patient. It consists of six parts: pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), physical mobility (8 items), and energy level (3 items). Higher scores correspond to poorer perceived health status.
Baseline, Change from baseline quality of life scores at three weeks, Change from baseline quality of life scores at three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cukurova University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bayram Kelle, Assoc. Prof., Cukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 72/1185

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings