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

Shoulder Pain Clinical Trial

— EFFECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478902
• Other study ID #: 1718862
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: December 2023
• Source: University of Valencia
• Contact: Lirios Dueñas, PT, PhD
• Phone: 0034655525373
• Email: liriosclinic[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: May 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calcific Tendinitis
• Calcinosis
• Rotator Cuff Injuries
• Rotator Cuff Tendinosis
• Shoulder Pain
• Shoulder Tendinitis
• Tendinopathy

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Spain	Universitat de Valencia	Valencia
Spain	Lluis Alcanyis Hospital	Xativa	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

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; — View Citation

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 — View Citation

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 E — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Type of calcification	according to the Gartner classification assessed with x-ray by an experienced radiologist	Baseline
Secondary	Type of calcification	according to the Gartner classification assessed with x-ray by an experienced radiologist	4 months
Secondary	Type of calcification	according to the Gartner classification assessed with x-ray by an experienced radiologist	12 months
Secondary	Size of the calcification	Measured in millimeters. Assessed with X-ray by an experienced radiologist	Baseline
Secondary	Size of the calcification	Measured in millimeters. Assessed with X-ray by an experienced radiologist	4 months
Secondary	Size of the calcification	Measured in millimeters. Assessed with X-ray by an experienced radiologist	12 months
Secondary	Location of the calcification	Which tendon is affected. Assessed with X-ray by an experienced radiologist	Baseline
Secondary	Location of the calcification	Which tendon is affected. Assessed with X-ray by an experienced radiologist	4 months
Secondary	Location of the calcification	Which tendon is affected. Assessed with X-ray by an experienced radiologist	12 months
Secondary	Morphology of the calcification	Isolated- fragmented - multiple. Assessed with X-ray by an experienced radiologist	Baseline
Secondary	Morphology of the calcification	Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist	4 months
Secondary	Morphology of the calcification	Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist	12 months
Secondary	Central Sensitization Inventory (CSI)	Patient-reported instrument to identify when patient's symptoms may be related to central sensitization	Baseline
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Self-reported questionnaire for measuring the subjective perception of sleep quality	Baseline
Secondary	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
Secondary	Tampa Scale for Kinesiophobia (TSK)	Self-reported questionnaire for measuring fear of movement or fear of (re)injury	Baseline
Secondary	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
Secondary	Pain Catastrophizing Scale	Patient-reported outcome to measure catastrophization	Baseline
Secondary	EuroQoL-5D	Patient-reported outcome to measure quality of life	Baseline
Secondary	Hospital Anxiety and Depression Scale	Patient-reported outcome to measure psychological factors	Baseline
Secondary	Patient Satisfaction	Global impression of change	2 weeks
Secondary	Patient Satisfaction	Global impression of change	4 months
Secondary	Patient Satisfaction	Global impression of change	6 months
Secondary	Patient Satisfaction	Global impression of change	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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