Biomodulating Rotator Cuff Healing - A Proof of Concept Trial

Study Overview
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Brief Summary
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Novel concepts in quantum biology of rotator cuff repair and author's novel findings on biomodulation inspired us to design a pragmatic non-pharmacological add-on rehabilitation protocol that may potentially decrease retear rates after arthroscopic repair using a knotted suturebridge technique. In this proof-of-concept trial, 146 patients will be randomized 1:1 to either a 6-weeks post-operative cryo-, photo- and electro-biomodulation protocol or a control group immobilized in a standard abduction sling for 6 weeks. Healing will be evaluated using the Sugaya classification on MRI at 1 year post-operatively.

Official Title
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Can Non-pharmacological BIOmodulation Improve Healing After Arthroscopic Rotator Cuff Repair Using a Knotted Suturebridge Technique?

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Other: Biomodulation (non-pharmacological)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patient is over 18 years old Patient presents with a symptomatic full-thickness tear as diagnosed preoperatively on ultrasound, arthro-CT or MRI. Absence of significant muscle atrophy or fatty infiltration of the affected tendon exceeding stage 2 of the Goutallier classification Exclusion criteria Partial rotator cuff tear or other shoulder injury Planned concomitant procedures other than subacromial decompression, acromioclavicular joint resection or biceps tenodesis/tenotomy Irreparable rotator cuff tear Patients who present with cartilage lesions greater than stage II of the Outerbridge classification (≥15mm diameter) on preoperative x-ray Patient presenting with a known comorbidity that could affect the outcome of surgery (cervical radiculopathy, polyarthritis, neurological disease of the upper limb) Patient not able to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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
Interventional Model Description: RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biomodulation<br>6-weeks post-operative cryo-, photo- and electro-biomodulation protocol after repair | Other: Biomodulation (non-pharmacological)<br>* cryo-, photo- and electro-biomodulation<br>|
| No Intervention: Control<br>standard rehabilitation after repair | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of rotator cuff tear | Healing will be evaluated using the Sugaya classification on MRI | 1 year post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome measures | Pain, reported as average of reported pain during movement, at rest and at night, measured by a numeric rating scale from 0 to 10; and the Auto-Constant score, Subjective Shoulder Value, the American Shoulder and Elbow Surgeon score Surgeon score | 6 months and 1 year | 
| Active range of motion | Degrees of forward flexion, abduction, internal rotation and external rotation (90 degrees elbow flexion, 0 and 90 degrees abduction) | 6 months and 1 year | 
| Compliance | Self-reported daily compliance to the different components of the biomodulation protocol | First 6 weeks after surgery | 
| Postoperative complications | Postoperative complications in the first year after surgery | First year after surgery |