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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporeal Shock Wave Therapy (ESWT) with Exercise | Experimental | 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. |
|
| Exercise Therapy Only | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aliaa Hussein | Contact | 01003041632 | +20 | aliaa.gamal@deraya.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of physical therapy, Deraya University | Recruiting | Minya | Menia Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23736252 | Background | Michener LA, Subasi Yesilyaprak SS, Seitz AL, Timmons MK, Walsworth MK. Supraspinatus tendon and subacromial space parameters measured on ultrasonographic imaging in subacromial impingement syndrome. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):363-9. doi: 10.1007/s00167-013-2542-8. Epub 2013 Jun 5. | |
| 35852027 | Background |
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Participants will be randomly assigned into two parallel groups. Group A (Experimental) will receive extracorporeal shock wave therapy (ESWT) in addition to a rotator cuff and scapular stabilization exercise program.
Group B (Active Comparator) will perform the same exercise program without ESWT.
Both groups will be treated for 6 weeks, with three exercise sessions per week.
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The study will use a double-blind design. Participants and the outcome assessor will be blinded to the group allocation. The physiotherapist administering ESWT and exercises will not participate in outcome measurements to minimize bias.
|
| 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. |
|
| Baseline and at 6 weeks post-intervention |
| Lyng KD, Andersen JD, Jensen SL, Olesen JL, Arendt-Nielsen L, Madsen NK, Petersen KK. The influence of exercise on clinical pain and pain mechanisms in patients with subacromial pain syndrome. Eur J Pain. 2022 Oct;26(9):1882-1895. doi: 10.1002/ejp.2010. Epub 2022 Jul 27. |
| 32670599 | Background | Liaghat B, Skou ST, Jorgensen U, Sondergaard J, Sogaard K, Juul-Kristensen B. Heavy shoulder strengthening exercise in people with hypermobility spectrum disorder (HSD) and long-lasting shoulder symptoms: a feasibility study. Pilot Feasibility Stud. 2020 Jul 10;6:97. doi: 10.1186/s40814-020-00632-y. eCollection 2020. |
| 27431359 | Background | Fournier Belley A, Gagnon DH, Routhier F, Roy JS. Ultrasonographic Measures of the Acromiohumeral Distance and Supraspinatus Tendon Thickness in Manual Wheelchair Users With Spinal Cord Injury. Arch Phys Med Rehabil. 2017 Mar;98(3):517-524. doi: 10.1016/j.apmr.2016.06.018. Epub 2016 Jul 16. |
| Background | 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 |
| 22081365 | Background | Fraenkel L, Falzer P, Fried T, Kohler M, Peters E, Kerns R, Leventhal H. Measuring pain impact versus pain severity using a numeric rating scale. J Gen Intern Med. 2012 May;27(5):555-60. doi: 10.1007/s11606-011-1926-z. Epub 2011 Nov 12. |
| 25954858 | Background | Alsanawi HA, Alghadir A, Anwer S, Roach KE, Alawaji A. Cross-cultural adaptation and psychometric properties of an Arabic version of the Shoulder Pain and Disability Index. Int J Rehabil Res. 2015 Sep;38(3):270-5. doi: 10.1097/MRR.0000000000000118. |
| 21843839 | Background | Breckenridge JD, McAuley JH. Shoulder Pain and Disability Index (SPADI). J Physiother. 2011;57(3):197. doi: 10.1016/S1836-9553(11)70045-5. |
| 38704572 | Background | Xue X, Song Q, Yang X, Kuati A, Fu H, Liu Y, Cui G. Effect of extracorporeal shockwave therapy for rotator cuff tendinopathy: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2024 May 4;25(1):357. doi: 10.1186/s12891-024-07445-7. |
| 39294797 | Background | Wang X, Jia S, Cui J, Xue X, Tian Z. 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. 2024 Sep 18;25(1):616. doi: 10.1186/s13063-024-08407-z. |
| 35281612 | Background | Fatima A, Ahmad A, Gilani SA, Darain H, Kazmi S, Hanif K. 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 Mar 4;2022:1230857. doi: 10.1155/2022/1230857. eCollection 2022. |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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