Effectiveness of Conservative Management in Rotator Cuff Calcific Tendinopathy (the EFFECT Trial)

Sponsor

University of Valencia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05478902

Collaborator

(none)

116

Enrollment

Location

Arms

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tendinosis Rotator Cuff Injuries Shoulder Tendinitis Calcific Shoulder Tendinitis Calcification Tendon Calcific Tendinitis Shoulder Pain	Procedure: Exercise Therapy Procedure: Extracorporeal Shockwave Therapy Procedure: Ultrasound-Guided Percutaneous Irrigation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Conservative Management in Rotator Cuff Calcific Tendinopathy: a Randomised Clinical Trial (the EFFECT Trial)

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

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 See group The wait and see group will not receive any intervention and will serve as a control group to determine the natural history of the rotator cuff calcific tendinopathy. It is important to note that participants allocated to this group will be offered the opportunity to receive treatment after the 12 months follow up if they still have symptoms. Due to COVID-19 reasons the waiting list for receiving treatment is being delayed so subjects assignation to the wait and see group will not suppose an unnecessary prorogation of the medical care.

Outcome Measures

Primary Outcome Measures

Shoulder Pain And Disability Index (SPADI) [Baseline]
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).
Shoulder Pain And Disability Index (SPADI) [4 months]
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).
Shoulder Pain And Disability Index (SPADI) [12 months]
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).

Secondary Outcome Measures

Pain Pressure Threshold (PPT) [Baseline]
PPTs will be recorded using an electronic algometer at the ipsilateral m. infraspinatus, the contralateral resting m. infraspinatus and the contralateral resting m. tibialis anterior. Higher values represent a better outcome.
Pain Intensity [Baseline]
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
Pain Intensity [4 months]
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
Pain Intensity [12 months]
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
Range of motion [Baseline]
Flexion, abduction and external rotation with inclinometer
Range of motion [4 months]
Flexion, abduction and external rotation with inclinometer
Range of motion [12 months]
Flexion, abduction and external rotation with inclinometer
Maximal Voluntary Contraction [Baseline]
At abduction and external rotation with a hand-held dynamometer
Maximal Voluntary Contraction [4 months]
At abduction and external rotation with a hand-held dynamometer
Maximal Voluntary Contraction [12 months]
At abduction and external rotation with a hand-held dynamometer
Type of calcification [Baseline]
according to the Gartner classification assessed with x-ray by an experienced radiologist
Type of calcification [4 months]
according to the Gartner classification assessed with x-ray by an experienced radiologist
Type of calcification [12 months]
according to the Gartner classification assessed with x-ray by an experienced radiologist

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.