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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05478902
Other study ID # 1718862
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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