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NCT Number: NCT07390396

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

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.

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Key information

Conditions

Rotator Cuff Tendinopathy Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Dysfunction Shoulder Pain Signs and Symptoms Supraspinatus Tendinopathy

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy, Deraya University

Minya, Menia Governorate, Egypt

Location status: Recruiting

Location contact

Aliaa Gamal Hussien

CONTACT

[email protected]

+201003041632

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal Shock Wave Therapy (ESWT) with Exercise

Other

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.

Exercise therapy

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aliaa Hussein

CONTACT

[email protected]

01003041632 ext. +20

Sponsors and collaborators

Lead sponsor

Deraya University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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