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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
146
cryo-, photo- and electro-biomodulation
Clinique Générale d'Annecy
Annecy, France
RECRUITINGHealing of rotator cuff tear
Healing will be evaluated using the Sugaya classification on MRI
Time frame: 1 year post-operatively
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
Time frame: 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)
Time frame: 6 months and 1 year
Compliance
Self-reported daily compliance to the different components of the biomodulation protocol
Time frame: First 6 weeks after surgery
Postoperative complications
Postoperative complications in the first year after surgery
Time frame: First year after surgery
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