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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biomodulation | Experimental | 6-weeks post-operative cryo-, photo- and electro-biomodulation protocol after repair |
|
| Control | No Intervention | standard rehabilitation after repair |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomodulation (non-pharmacological) | Other | cryo-, photo- and electro-biomodulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing of rotator cuff tear | Healing will be evaluated using the Sugaya classification on MRI | 1 year post-operatively |
| 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 |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Générale d'Annecy | Recruiting | Annecy | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37586862 | Derived | Allaart LJH, Lech J, Macken AA, Kling A, Lafosse L, Lafosse T, van den Bekerom MPJ, Buijze GA. Biomodulating healing after arthroscopic rotator cuff repair: the protocol of a randomised proof of concept trial (BIOHACK). BMJ Open. 2023 Aug 16;13(8):e071078. doi: 10.1136/bmjopen-2022-071078. |
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Due to privacy reasons individual patient data will not be available to the public.
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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RCT
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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 |