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

Deraya University

Status: Enrolling

Conditions: Shoulder Pain; Shoulder Dysfunction; Rotator Cuff Tendinopathy; Supraspinatus Tendinopathy

Treatments: Other: Exercise Therapy; Other: Extracorporeal Shock Wave Therapy (ESWT) with Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07390396

DU-PT-ESWT-RCT-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Extracorporeal Shock Wave Therapy (ESWT) with Exercise

Experimental group

Description:

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.

Treatment:

Other: Extracorporeal Shock Wave Therapy (ESWT) with Exercise

Exercise Therapy Only

Active Comparator group

Description:

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.

Treatment:

Other: Exercise Therapy