Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL)

NCT05478902 | Unknown

• 1 other identifier: 1718862
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study will be to compare the effectiveness of an exercise therapy program with extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation and a wait and see approach in people with rotator cuff calcific tendinopathy.

Conditions

Rotator Cuff Tendinosis; Rotator Cuff Injuries; Shoulder Tendinitis; Calcific Shoulder Tendinitis; Calcification Tendon; Calcific Tendinitis; Shoulder Pain

Keywords

exercise therapy; lavage; rotator cuff calcific tendinopathy; shoulder calcification; extracorporeal shockwave therapy; ultrasound-guided percutaneous irrigation; shoulder pain; shape up my shoulders; sums

Outcome Measures

Primary Outcomes (5)

• Shoulder Pain And Disability Index (SPADI)

  Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).

  Baseline

• Shoulder Pain And Disability Index (SPADI)

  Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).

  2 weeks

• Shoulder Pain And Disability Index (SPADI)

  Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).

  4 months

• Shoulder Pain And Disability Index (SPADI)

  Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).

  6 months

• Shoulder Pain And Disability Index (SPADI)

  Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).

  12 months

Secondary Outcomes (37)

• Pain Intensity

  Baseline

• Pain Intensity

  2 weeks

• Pain Intensity

  4 months

• Pain Intensity

  6 months

• Pain Intensity

  12 months

Study Arms (4)

Exercise Therapy

EXPERIMENTAL

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.

Procedure: Exercise Therapy

Extracorporeal Shockwave Therapy

ACTIVE COMPARATOR

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.

Procedure: Extracorporeal Shockwave Therapy

Ultrasound-Guided Percutaneous Irrigation

ACTIVE COMPARATOR

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.

Procedure: Ultrasound-Guided Percutaneous Irrigation

Wait and Watch group

NO INTERVENTION

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.

Interventions

Exercise Therapy PROCEDURE

Exercise protocol for rotator cuff related shoulder pain

Also known as: Shape Up My Shoulders Protocol

Exercise Therapy

Extracorporeal Shockwave Therapy PROCEDURE

High Energy Extracorporeal Shockwave Therapy

Extracorporeal Shockwave Therapy

Ultrasound-Guided Percutaneous Irrigation PROCEDURE

Two sessions of Ultrasound-Guided Percutaneous Irrigation

Also known as: Lavage

Ultrasound-Guided Percutaneous Irrigation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• calcification deposit in the rotator cuff confirmed by diagnostic imaging (ultrasound, MRI or X-ray);
• pain and loss of function in the shoulder;
• not currently receiving physiotherapy or ESWT.

You may not qualify if:

• previous treatments on last year (e.g., injections, ESWT, US-PICT, surgery, etc.);
• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (2)

Lluis Alcanyis Hospital

Xàtiva, Valencia, 46800, Spain

RECRUITING

Universitat de Valencia

Valencia, 46020, Spain

RECRUITING

Related Publications (8)

• 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.

  PMID: 30774461 RESULT

• 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.

  PMID: 32830280 RESULT

• 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.

  PMID: 17188907 RESULT

• 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.

  PMID: 25870115 RESULT

• 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.

  PMID: 10797220 RESULT

• 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.

  PMID: 22745199 RESULT

• 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.

  PMID: 31191964 RESULT

• 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.

  PMID: 38176875 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy; Shoulder Pain

Interventions

Exercise Therapy; Extracorporeal Shockwave Therapy; Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Hydrotherapy; Investigative Techniques

Study Officials

• Enrique Lluch, PT, PhD

  University of Valencia

  STUDY DIRECTOR

Central Study Contacts

Lirios Dueñas, PT, PhD

CONTACT

0034655525373; liriosclinic@gmail.com

Iván Caballero, PT, MSc

CONTACT

0034649109143; ivancaballerofisioterapia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Professor

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 28, 2022
• Study Start: May 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)