Effect of Adding Extracorporeal Shock Wave Therapy to Exercises in Rotator Cuff Tendinopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-55
SponsorDeraya University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Extracorporeal Shock Wave Therapy (ESWT) with Exercise
Other interventionFocused 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 interventionA 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Extracorporeal Shock Wave Therapy (ESWT) with ExerciseExperimental treatment 1 intervention
Group B: Exercise Therapy OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and at 6 weeks post-intervention2
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.
Time frame
Baseline and at 6 weeks post-intervention3
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.
Time frame
Baseline and at 6 weeks post-intervention4
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.
Time frame
Baseline and at 6 weeks post-interventionSponsors and contacts
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Source ClinicalTrials.gov