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

University of Valencia

Status: Enrolling

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

Treatments: Procedure: Extracorporeal Shockwave Therapy; Procedure: Exercise Therapy; Procedure: Ultrasound-Guided Percutaneous Irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT05478902

1718862

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 4 patient groups

Exercise Therapy

Experimental group

Description:

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.

Treatment:

Procedure: Exercise Therapy

Extracorporeal Shockwave Therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Extracorporeal Shockwave Therapy

Ultrasound-Guided Percutaneous Irrigation

Active Comparator group

Description:

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.

Treatment:

Procedure: Ultrasound-Guided Percutaneous Irrigation

Wait and Watch group

No Intervention group

Description:

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.