NCT04593342

Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair

Evaluation of the Efficacy of B-Cure Laser Treatment on Pain and Functionality Following Arthroscopic Rotator Cuff Repair: A Prospective Double Blind, Randomized, Sham-Controlled Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Erika Carmel ltd · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Rehabilitation following rotator cuff surgery is characterized with high levels of pain, limited range of motion, and decreased quality of life. The purpose of this study is to evaluate the B-Cure laser photobiomodulation home-use device in addition to standard care, for the reduction of pain, increase in functionality, and improvement of life quality during rehabilitation following rotator cuff arthroscopic surgery.

Detailed description

Patients planned to undergo rotator cuff arthroscopy will be randomized to receive active or sham devices for self-application at home in addition to standard care. Patients will be invited to up to 5 visits at the clinic: baseline (before surgery), post-operative day 1, and 1, 3, and optionally 6 months after surgery. Evaluations will include physical examination, physical activity tests, range of motion measurements, Constant score, thermal imaging, and patient reported outcomes including subjective pain level by visual analogue scale, functional and quality of life questionnaires. The study hypothesis is that B-Cure laser treatments, applied, at home, by the patient, can reduce pain and accelerate healing over standard care thereby improving the rehabilitation process following rotator cuff arthroscopic surgery.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
DEVICE	B-Cure Pro	The B-Cure laser Pro is a portal, non-invasive, low level laser therapy device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 5J/min.
DEVICE	Sham	The sham device is externally identical to the B-Cure Pro and emit the same guiding light, but does not emit the therapeutic near infrared rays.

Timeline

• Start date: 2020-11-26
• Primary completion: 2022-03-25
• Completion: 2022-04-11
• First posted: 2020-10-20
• Last updated: 2022-04-28

Locations

1 site across 1 country: Israel