Effect of Extracorporeal Shock Wave Therapy on Exercises in Rotator Cuff Tendinopathy

August 26, 2026 updated by: Deraya University

Effect of Adding Extracorporeal Shock Wave Therapy to Exercises in Rotator Cuff Tendinopathy: A Randomized Controlled Trial

Rotator cuff tendinopathy (RCT) is one of the most common causes of shoulder pain, resulting in functional limitations and reduced quality of life. Exercise therapy is considered a first-line treatment; however, adjunct modalities such as extracorporeal shock wave therapy (ESWT) may enhance recovery. This study aims to evaluate the effect of adding ESWT to a rotator cuff and scapular stabilization exercise program in patients with rotator cuff tendinopathy.

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.

Detailed Description

Rotator cuff tendinopathy involves chronic overload and microtrauma of the rotator cuff tendons, leading to pain, inflammation, and functional impairment. Therapeutic exercises that target the rotator cuff and scapular stabilizers are commonly prescribed to restore muscle control and shoulder kinematics.

Extracorporeal shock wave therapy (ESWT) has demonstrated potential for tendon regeneration, pain reduction, and improved vascularization. This randomized controlled trial investigates whether the combination of ESWT and exercise therapy produces greater improvements than exercise therapy alone in reducing supraspinatus tendon thickness and pain and improving shoulder function.

Fifty participants aged 30-55 years with confirmed RCT will be randomly assigned into two groups:

  • Group A (Experimental): ESWT + rotator cuff and scapular stabilization exercises.
  • Group B (Active Comparator): Rotator cuff and scapular stabilization exercises only.

Both groups will be treated for 6 weeks, with 3 exercise sessions per week; Group A will receive 1 ESWT session weekly in addition to exercises.

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.
50

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Menia Governorate
      • Minya, Menia Governorate, Egypt
        • faculty of physical therapy, Deraya University

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medically stable individuals who consent to participate in the study.
  • Male and female participants aged between 30 and 55 years.
  • Diagnosed with rotator cuff tendinopathy, confirmed clinically and by ultrasound or MRI.
  • Duration of symptoms greater than 3 months.
  • Supraspinatus tendon thickness > 5.85 mm as measured by ultrasound (based on Hunter et al., 2021).
  • Able to follow the treatment plan and attend all therapy sessions.

Exclusion Criteria:

  • Massive rotator cuff tear or complete tendon rupture.
  • Adhesive capsulitis or significant limitation of passive shoulder motion.
  • History of shoulder fracture, dislocation, or surgery in the affected limb.
  • Rheumatoid arthritis, diabetes mellitus, or systemic inflammatory disease.
  • Cervical radiculopathy or neurological involvement affecting the shoulder.
  • Corticosteroid injection in the affected shoulder within the last 6 months.
  • Pregnancy or breastfeeding.
  • BMI > 30 kg/m² (obese individuals excluded).
  • Current malignancy, open wounds, or local infection at the treatment site.
  • Inability to tolerate shock wave therapy or perform exercise sessions.

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: Extracorporeal Shock Wave Therapy (ESWT) with Exercise

Participants in this group will receive extracorporeal shock wave therapy (ESWT) applied to the supraspinatus tendon once weekly for 6 weeks, in addition to a rotator cuff and scapular stabilization exercise program performed three times per week.

ESWT will be applied using a focused probe at 1.5 bar pressure, 1500 shocks per session. Exercises will include strengthening and control exercises for rotator cuff and scapular muscles.
Other: Extracorporeal Shock Wave Therapy (ESWT) with Exercise

Focused extracorporeal shock wave therapy (ESWT) will be applied to the supraspinatus tendon at 1.5 bar, 1500 shocks per session, once weekly for 6 weeks, in combination with a rotator cuff and scapular stabilization exercise program performed three times weekly.

This combination is designed to promote tendon healing, improve strength, and reduce shoulder pain.
Active Comparator: Exercise Therapy Only

Participants in this group will perform the same rotator cuff and scapular stabilization exercise program as the experimental group, without receiving ESWT.

The exercise program focuses on strengthening, stretching, and neuromuscular control of shoulder and scapular stabilizers, performed three times per week for 6 weeks.
Other: Exercise Therapy

A standardized rotator cuff and scapular stabilization exercise program including strengthening, stretching, and control training for the shoulder complex. Exercises are performed three times weekly for 6 weeks under supervision.

This program serves as the active control for comparison with ESWT + Exercise.

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
Change in Supraspinatus Tendon Thickness
Time Frame: Baseline and at 6 weeks post-intervention
Supraspinatus tendon thickness will be measured using diagnostic ultrasonography in the transverse plane. Participants will be positioned in the modified Crass position (palm on iliac crest, elbow directed posteriorly) as described by Ferri et al. (2005). The transducer will be placed on the acromion and moved laterally to visualize the supraspinatus tendon. A decrease in tendon thickness after 6 weeks of treatment indicates structural improvement. Measurements will be taken at baseline and at 6 weeks post-intervention.
Baseline and at 6 weeks post-intervention
Change in Shoulder Pain Intensity (Numeric Pain Rating Scale, NPRS)
Time Frame: Baseline and at 6 weeks post-intervention
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their average shoulder pain over the previous week. A lower score after treatment indicates improvement. Measurements will be taken at baseline and at 6 weeks post-intervention.
Baseline and at 6 weeks post-intervention
Change in Shoulder Disability (Shoulder Pain and Disability Index, SPADI)
Time Frame: Baseline and at 6 weeks post-intervention
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index (SPADI). This self-reported questionnaire includes 13 items scored from 0-10. The total score is expressed as a percentage, with higher scores indicating greater pain and disability. The SPADI will be administered at baseline and at 6 weeks post-intervention.
Baseline and at 6 weeks post-intervention
Change in Isometric Shoulder Muscle Strength
Time Frame: Baseline and at 6 weeks post-intervention
Isometric strength of the shoulder external and internal rotator muscles will be measured using a handheld dynamometer. Participants will perform maximal voluntary contractions in a standardized seated position. Three trials will be performed for each direction of movement, and the mean value will be recorded in Newtons (N). Increased strength after treatment indicates functional improvement.
Baseline and at 6 weeks post-intervention

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.
Deraya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
December 15, 2025

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.
May 15, 2026

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.
May 20, 2026

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).
January 29, 2026

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.
January 29, 2026

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.
February 5, 2026

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.
August 28, 2026

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.
August 26, 2026

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.
August 1, 2026

More Information

Terms related to this study

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.
  • DU-PT-ESWT-RCT-003

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.

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