Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL)
NCT ID: NCT05478902
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
116 participants
INTERVENTIONAL
2023-05-01
2025-05-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exercise Therapy
This group will receive the Shape Up My Shoulders (SUMS) protocol and it will be led by a physiotherapist trained in therapeutic exercise. It will last 12 weeks and it will be divided in 3 stages.
Stage I- Early-stage rehabilitation exercises (i.e., breathing and relaxation exercises, ball rolling exercises, hand gripping exercises, mental imagery and contralateral side exercises) and Shoulder Symptom Modification Procedure (SSMP). This stage typically lasts 1 to 2 weeks.
Stage II - Isometric, eccentric and heavy slow resistance exercises. The final part of Stage II is a progression from eccentric only to eccentric and concentric contractions.
Stage III - Functional program. This stage starts in week 5 or 6 and progressed to week 12. Involves pushing, pulling, throwing, lifting, carrying, and precision (sensory-motor control) exercises.
Exercise Therapy
Exercise protocol for rotator cuff related shoulder pain
Extracorporeal Shockwave Therapy
This group will receive high energy Extracorporeal Shockwave Therapy (ESWT) applied by an experienced physiotherapist. ESWT will be applied on the most tender point of the shoulder, located by palpation. The dose will be 1500 impulses per session without anaesthesia and an intensity between 0.15 and 0.30 mJ/mm2 depending on patient tolerance. A total of 4 treatment sessions (1 session per week) with 1 week of rest between sessions will be implemented. Patient's position during the treatment will be seated in supine position with shoulder hyperextension and internal rotation with the hand placed below the contralateral glute with the palm touching the table.
Extracorporeal Shockwave Therapy
High Energy Extracorporeal Shockwave Therapy
Ultrasound-Guided Percutaneous Irrigation
This intervention will be performed by an experienced interventionist radiologist in two sessions. The shoulder position will be with hyperextension and internal rotation with the hand behind the back. One 20 mL syringe with saline solution, one with an anaesthetic with 20 mg/mL of mepivacaine 2% and another syringe with a corticoid injection with 40 mg/mL of triamcinolone acetonide will be prepared before the intervention. Firstly, the anaesthetic will be injected directed to the calcification. Then, the procedure will consist of injecting saline solution and aspiring the calcific deposits until it is neither possible to aspire more inside the syringe nor to detect any calcifications with ultrasound imaging. After that, a corticoid will be injected to the bursa to prevent the appearance of subacromial bursitis. Finally, an anaesthetic will be injected during the extraction of the needle.
Ultrasound-Guided Percutaneous Irrigation
Two sessions of Ultrasound-Guided Percutaneous Irrigation
Wait and Watch group
The wait and see group will not receive any intervention and will serve as a control group to determine the natural history of RCCT. If one treatment proves to be more effective then participants in the other groups will be offered that treatment after 12 months, or before, if the investigation finishes early due to an obvious group difference and a need to break randomisation codes.
No interventions assigned to this group
Interventions
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Exercise Therapy
Exercise protocol for rotator cuff related shoulder pain
Extracorporeal Shockwave Therapy
High Energy Extracorporeal Shockwave Therapy
Ultrasound-Guided Percutaneous Irrigation
Two sessions of Ultrasound-Guided Percutaneous Irrigation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* pain and loss of function in the shoulder;
* not currently receiving physiotherapy or ESWT.
Exclusion Criteria
* other shoulder disorders or trauma (e.g., fractures, dislocations, rotator cuff tears, frozen shoulder or shoulder instability);
* known allergy to any of the pharmacological products used in the study;
* taking oral anticoagulants
* taking oral steroid within the six months prior to participation in the study;
* cancer, systemic disease, pregnancy or infection;
* neck pain.
18 Years
75 Years
ALL
No
Sponsors
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University of Valencia
OTHER
Responsible Party
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Lirios Dueñas
PhD Professor
Principal Investigators
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Enrique Lluch, PT, PhD
Role: STUDY_DIRECTOR
University of Valencia
Locations
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Lluis Alcanyis Hospital
Xàtiva, Valencia, Spain
Universitat de Valencia
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Cristina Gallego, MD
Role: primary
Lirios Dueñas Moscardó, PhD
Role: primary
References
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Sansone V, Maiorano E, Galluzzo A, Pascale V. Calcific tendinopathy of the shoulder: clinical perspectives into the mechanisms, pathogenesis, and treatment. Orthop Res Rev. 2018 Oct 3;10:63-72. doi: 10.2147/ORR.S138225. eCollection 2018.
Simpson M, Pizzari T, Cook T, Wildman S, Lewis J. Effectiveness of non-surgical interventions for rotator cuff calcific tendinopathy: A systematic review. J Rehabil Med. 2020 Oct 31;52(10):jrm00119. doi: 10.2340/16501977-2725.
Harvie P, Pollard TC, Carr AJ. Calcific tendinitis: natural history and association with endocrine disorders. J Shoulder Elbow Surg. 2007 Mar-Apr;16(2):169-73. doi: 10.1016/j.jse.2006.06.007. Epub 2006 Dec 22.
Louwerens JK, Sierevelt IN, van Hove RP, van den Bekerom MP, van Noort A. Prevalence of calcific deposits within the rotator cuff tendons in adults with and without subacromial pain syndrome: clinical and radiologic analysis of 1219 patients. J Shoulder Elbow Surg. 2015 Oct;24(10):1588-93. doi: 10.1016/j.jse.2015.02.024. Epub 2015 Apr 11.
Uhthoff HK, Loehr JW. Calcific Tendinopathy of the Rotator Cuff: Pathogenesis, Diagnosis, and Management. J Am Acad Orthop Surg. 1997 Jul;5(4):183-191. doi: 10.5435/00124635-199707000-00001.
Ioppolo F, Tattoli M, Di Sante L, Attanasi C, Venditto T, Servidio M, Cacchio A, Santilli V. Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: a randomized clinical trial comparing two different energy levels. Phys Ther. 2012 Nov;92(11):1376-85. doi: 10.2522/ptj.20110252. Epub 2012 Jun 28.
Lafrance S, Doiron-Cadrin P, Saulnier M, Lamontagne M, Bureau NJ, Dyer JO, Roy JS, Desmeules F. Is ultrasound-guided lavage an effective intervention for rotator cuff calcific tendinopathy? A systematic review with a meta-analysis of randomised controlled trials. BMJ Open Sport Exerc Med. 2019 Mar 9;5(1):e000506. doi: 10.1136/bmjsem-2018-000506. eCollection 2019.
Caballero I, Duenas L, Balasch-Bernat M, Fernandez-Matias R, Breso-Parra L, Gallego-Terres C, Aroca Navarro JE, Navarro-Bosch M, Lewis J, Lluch Girbes E. Effectiveness of non-surgical management in rotator cuff calcific tendinopathy (the effect trial): protocol for a randomised clinical trial. BMJ Open. 2024 Jan 4;14(1):e074949. doi: 10.1136/bmjopen-2023-074949.
Other Identifiers
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1718862
Identifier Type: -
Identifier Source: org_study_id