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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Rotator Cuff Tendinosis, Rotator Cuff Injuries, Shoulder Tendinitis, Calcific Shoulder Tendinitis, Calcification Tendon, Calcific Tendinitis, Shoulder Pain

Intervention / Treatment
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* Procedure: Exercise Therapy
* Procedure: Extracorporeal Shockwave Therapy
* Procedure: Ultrasound-Guided Percutaneous Irrigation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Therapy<br>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<br>* Exercise protocol for rotator cuff related shoulder pain<br>* Other names: Shape Up My Shoulders Protocol;|
| Active Comparator: Extracorporeal Shockwave Therapy<br>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<br>* High Energy Extracorporeal Shockwave Therapy<br>|
| Active Comparator: Ultrasound-Guided Percutaneous Irrigation<br>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<br>* Two sessions of Ultrasound-Guided Percutaneous Irrigation<br>* Other names: Lavage;|
| No Intervention: Wait and Watch group<br>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?
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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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise therapy, lavage, rotator cuff calcific tendinopathy, shoulder calcification, extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation, shoulder pain, shape up my shoulders, sums