Biomodulating Rotator Cuff Healing - A Proof of Concept Trial

Not Applicable

Recruiting

• Conditions: Rotator Cuff Tears
• Interventions: Other: Biomodulation (non-pharmacological)

• Registration Number: NCT04618484
• Lead Sponsor: Clinique Générale dAnnecy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2020-11-01
• Study First Posted: 2020-11-06
• Study Start: 2021-12-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-29
• Last Update Posted: 2023-07-03
• Primary Completion: 2024-05
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biomodulation	Biomodulation (non-pharmacological)	6-weeks post-operative cryo-, photo- and electro-biomodulation protocol after repair

Primary Outcome Measures

Name	Time	Method
Healing of rotator cuff tear	1 year post-operatively	Healing will be evaluated using the Sugaya classification on MRI

Secondary Outcome Measures

Name	Time	Method
Active range of motion	6 months and 1 year	Degrees of forward flexion, abduction, internal rotation and external rotation (90 degrees elbow flexion, 0 and 90 degrees abduction)
Postoperative complications	First year after surgery	Postoperative complications in the first year after surgery
Patient reported outcome measures	6 months and 1 year	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
Compliance	First 6 weeks after surgery	Self-reported daily compliance to the different components of the biomodulation protocol

Trial Locations

Locations (1)

Clinique Générale d'Annecy; 🇫🇷 Annecy, France