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

Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy: a Randomised Clinical Trial (THE EFFECT TRIAL)

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Injuries; Shoulder Pain; Rotator Cuff Tendinosis; Calcific Tendinitis; Shoulder Tendinitis; Calcific Shoulder Tendinitis; Calcification Tendon
• Intervention / Treatment: Procedure: Exercise Therapy; Procedure: Extracorporeal Shockwave Therapy; Procedure: Ultrasound-Guided Percutaneous Irrigation

Detailed Description

Rotator cuff calcific tendinopathy (RCCT) is a common musculoskeletal disorder caused by the presence of calcific deposits in the rotator cuff with an important impact in the quality of life of those who are suffering it. Conservative interventions such as extracorporeal shockwave therapy (ESWT) or ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) have been commonly recommended as part of the early management for this clinical condition. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been tested in people with RCCT yet. A randomised, single-blinded four parallel group clinical trial will be conducted. Participants (n=116) will be randomised in four groups: (1) ET; (2) ESWT; (3) US-PICT or (4) control.

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iván Caballero, PT, MSc; Phone Number: 0034649109143; Email: ivancaballerofisioterapia@gmail.com
• Study Contact Backup: Name: Lirios Dueñas, PT, PhD; Phone Number: 0034655525373; Email: liriosclinic@gmail.com

Study Locations

• Spain
  • Valencia, Spain, 46020
    • Recruiting
    • Universitat de València
    • Contact: Lirios Dueñas Moscardó, PhD; Phone Number: 0034655525373; Email: liriosclinic@gmail.com
  • Valencia
    • Xativa, Valencia, Spain, 46800
      • Recruiting
      • Lluis Alcanyis Hospital
      • Contact: Cristina Gallego, MD; Phone Number: +34 691870052; Email: crisgallegoterres@gmail.com
      • Principal Investigator: Cristina Gallego-Terres, MD
      • Principal Investigator: Luis Bresó-Parra, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Exercise Therapy; Exercise protocol for rotator cuff related shoulder pain; Other Names: Shape Up My Shoulders Protocol
Active Comparator: 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.	Procedure: Extracorporeal Shockwave Therapy; High Energy Extracorporeal Shockwave Therapy
Active Comparator: 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.	Procedure: Ultrasound-Guided Percutaneous Irrigation; Two sessions of Ultrasound-Guided Percutaneous Irrigation; Other Names: Lavage
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain). Flexion, abduction, external rotation and hand behind the back	Baseline
Pain Intensity	Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain). Flexion, abduction, external rotation and hand behind the back	2 weeks
Pain Intensity	Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain). Flexion, abduction, external rotation and hand behind the back	4 months
Pain Intensity	Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain). Flexion, abduction, external rotation and hand behind the back	6 months
Pain Intensity	Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain). Flexion, abduction, external rotation and hand behind the back	12 months
Type of calcification	according to the Gartner classification assessed with x-ray by an experienced radiologist	Baseline
Type of calcification	according to the Gartner classification assessed with x-ray by an experienced radiologist	4 months
Type of calcification	according to the Gartner classification assessed with x-ray by an experienced radiologist	12 months
Range of motion	Flexion, abduction and hand behind the back measured with a questionnaire with different stages. Degrees measured in different stages ranged from 0-30º, 30-60º, 60-90º, 90-120º, 120-150º and above 150º for flexion and abduction. For hand behind the back: hand to the hip, to the buttock, low back, mid back or between scapulas.	Baseline
Range of motion	Flexion, abduction and hand behind the back measured with a questionnaire with different stages. Degrees measured in different stages ranged from 0-30º, 30-60º, 60-90º, 90-120º, 120-150º and above 150º for flexion and abduction. For hand behind the back: hand to the hip, to the buttock, low back, mid back or between scapulas.	4 months
Range of motion	Flexion, abduction and hand behind the back measured with a questionnaire with different stages. Degrees measured in different stages ranged from 0-30º, 30-60º, 60-90º, 90-120º, 120-150º and above 150º for flexion and abduction. For hand behind the back: hand to the hip, to the buttock, low back, mid back or between scapulas.	12 months
Size of the calcification	Measured in millimeters. Assessed with X-ray by an experienced radiologist	Baseline
Size of the calcification	Measured in millimeters. Assessed with X-ray by an experienced radiologist	4 months
Size of the calcification	Measured in millimeters. Assessed with X-ray by an experienced radiologist	12 months
Location of the calcification	Which tendon is affected. Assessed with X-ray by an experienced radiologist	Baseline
Location of the calcification	Which tendon is affected. Assessed with X-ray by an experienced radiologist	4 months
Location of the calcification	Which tendon is affected. Assessed with X-ray by an experienced radiologist	12 months
Morphology of the calcification	Isolated- fragmented - multiple. Assessed with X-ray by an experienced radiologist	Baseline
Morphology of the calcification	Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist	4 months
Morphology of the calcification	Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist	12 months
Central Sensitization Inventory (CSI)	Patient-reported instrument to identify when patient's symptoms may be related to central sensitization	Baseline
Pittsburgh Sleep Quality Index (PSQI)	Self-reported questionnaire for measuring the subjective perception of sleep quality	Baseline
Fear Avoidance Beliefs Questionnaire (FABQ)	Patient-reported instrument for measuring fear avoidance and beliefs. The score range is 0 to 96, with a higher value reflecting a higher degree of fear avoidance beliefs.	Baseline
Tampa Scale for Kinesiophobia (TSK)	Self-reported questionnaire for measuring fear of movement or fear of (re)injury	Baseline
painDETECT Scale	Self-administered questionnaire, developed to quickly detect neuropathic pain, asking the patient about the pain experienced at the moment and with- in the last 4 weeks	Baseline
Pain Catastrophizing Scale	Patient-reported outcome to measure catastrophization	Baseline
EuroQoL-5D	Patient-reported outcome to measure quality of life	Baseline
Hospital Anxiety and Depression Scale	Patient-reported outcome to measure psychological factors	Baseline
Patient Satisfaction	Global impression of change	2 weeks
Patient Satisfaction	Global impression of change	4 months
Patient Satisfaction	Global impression of change	6 months
Patient Satisfaction	Global impression of change	12 months
Night Pain	How much has the pain affected the patient at night in the last 4 weeks. From 1 to 5. 5 means worst. 1: No pain. 2: Pain 1 or 2 nights in the last 4 weeks. 3: 1 or 2 nights a week. 4: Pain almost every night. 5: Pain every night.	Baseline
Night Pain	How much has the pain affected the patient at night in the last 4 weeks. From 1 to 5. 5 means worst. 1: No pain. 2: Pain 1 or 2 nights in the last 4 weeks. 3: 1 or 2 nights a week. 4: Pain almost every night. 5: Pain every night.	2 weeks
Night Pain	How much has the pain affected the patient at night in the last 4 weeks. From 1 to 5. 5 means worst. 1: No pain. 2: Pain 1 or 2 nights in the last 4 weeks. 3: 1 or 2 nights a week. 4: Pain almost every night. 5: Pain every night.	4 months
Night Pain	How much has the pain affected the patient at night in the last 4 weeks. From 1 to 5. 5 means worst. 1: No pain. 2: Pain 1 or 2 nights in the last 4 weeks. 3: 1 or 2 nights a week. 4: Pain almost every night. 5: Pain every night.	6 months
Night Pain	How much has the pain affected the patient at night in the last 4 weeks. From 1 to 5. 5 means worst. 1: No pain. 2: Pain 1 or 2 nights in the last 4 weeks. 3: 1 or 2 nights a week. 4: Pain almost every night. 5: Pain every night.	12 months

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Study Director: Enrique Lluch, PT, PhD, University of Valencia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: exercise therapy; lavage; shoulder pain; extracorporeal shockwave therapy; rotator cuff calcific tendinopathy; shoulder calcification; ultrasound-guided percutaneous irrigation; shape up my shoulders; sums
• Additional Relevant MeSH Terms: Metabolic Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arthralgia; Calcium Metabolism Disorders; Rotator Cuff Injuries; Tendinopathy; Shoulder Pain; Calcinosis
• Other Study ID Numbers: 1718862

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No