Effect of Adding Extracorporeal Shock Wave Therapy to Exercises in Rotator Cuff Tendinopathy

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: Recruiting
• Conditions: Shoulder Pain; Rotator Cuff Tendinopathy; Supraspinatus Tendinopathy; Shoulder Dysfunction
• Intervention / Treatment: Other: Extracorporeal Shock Wave Therapy (ESWT) with Exercise; Other: Exercise Therapy

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: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aliaa Hussein; Phone Number: +20 01003041632; Email: aliaa.gamal@deraya.edu.eg

Study Locations

• Egypt
  • Menia Governorate
    • Minya, Menia Governorate, Egypt
      • Recruiting
      • faculty of physical therapy, Deraya University
      • Contact: Aliaa Gamal Hussien; Phone Number: +201003041632; Email: aliaa.gamal@deraya.edu.eg

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Supraspinatus Tendon Thickness	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)	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)	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	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

• Sponsor: Deraya University

Publications and helpful links

General Publications

• Michener, L. A., Subasi Yesilyaprak, S. S., Seitz, A. L., Timmons, M. K., & Walsworth, M. K. (2015). Supraspinatus tendon and subacromial space parameters measured on ultrasonographic imaging in subacromial impingement syndrome. Knee Surgery, Sports Traumatology, Arthroscopy, 23(2), 363-369.
• Lyng, K. D., Andersen, J. D., Jensen, S. L., Olesen, J. L., Arendt-Nielsen, L., Madsen, N. K., & Petersen, K. K. (2022, Oct). The influence of exercise on clinical pain and pain mechanisms in patients with subacromial pain syndrome. Eur J Pain, 26(9), 1882-1895. https://doi.org/10.1002/ejp.2010
• Liaghat, B., Skou, S. T., Jørgensen, U., Sondergaard, J., Søgaard, K., & Juul-Kristensen, B. (2020). Heavy shoulder strengthening exercise in people with hypermobility spectrum disorder (HSD) and long-lasting shoulder symptoms: a feasibility study. Pilot Feasibility Stud, 6, 97. https://doi.org/10.1186/s40814-020-00632-y
• Belley, A. F., Gagnon, D. H., Routhier, F., & Roy, J.-S. (2017). Ultrasonographic measures of the acromiohumeral distance and supraspinatus tendon thickness in manual wheelchair users with spinal cord injury. Archives of physical medicine and rehabilitation, 98(3), 517-524.
• Beshay, N., Lam, P. H., & Murrell, G. A. C. (2011). Assessing the Reliability of Shoulder Strength Measurement: Hand-Held versus Fixed Dynamometry. Shoulder & Elbow, 3(4), 244-251. https://doi.org/10.1111/j.1758-5740.2011.00137.x
• Fraenkel, L., Cunningham, M., Peters, E., & Seligman, C. (2012). Measuring pain impact versus pain severity using a numeric rating scale. Journal of General Internal Medicine, 27(5), 555-560. https://doi.org/10.1007/s11606-011-1932-1
• Alsanawi, H. A., Alghadir, A., Anwer, S., Roach, K. E., & Alawaji, A. (2015). Cross-cultural adaptation and psychometric properties of an Arabic version of the Shoulder Pain and Disability Index. International Journal of Rehabilitation Research, 38(3), 270-275. https://doi.org/10.1097/mrr.0000000000000118
• Breckenridge, J. D., & McAuley, J. H. (2011). Shoulder Pain and Disability Index (SPADI). J Physiother, 57(3), 197. https://doi.org/10.1016/s1836-9553(11)70045-5
• Xue, X., Song, Q., Yang, X., Kuati, A., Fu, H., Liu, Y., & Cui, G. (2024, May 4). Effect of extracorporeal shockwave therapy for rotator cuff tendinopathy: a systematic review and meta-analysis. BMC Musculoskelet Disord, 25(1), 357. https://doi.org/10.1186/s12891-024-07445-7
• Wang, X., Jia, S., Cui, J., Xue, X., & Tian, Z. (2024, Sep 18). Effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on rotator cuff calcific tendinitis: study protocol for a randomized controlled trial. Trials, 25(1), 616. https://doi.org/10.1186/s13063-024-08407-z
• Fatima, A., Ahmad, A., Gilani, S. A., Darain, H., Kazmi, S., & Hanif, K. (2022). Effects of High-Energy Extracorporeal Shockwave Therapy on Pain, Functional Disability, Quality of Life, and Ultrasonographic Changes in Patients with Calcified Rotator Cuff Tendinopathy. Biomed Res Int, 2022, 1230857. https://doi.org/10.1155/2022/1230857

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Arthralgia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Shoulder Pain; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy; Exercise Therapy
• Other Study ID 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