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Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair

NCT04593342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-04-28

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tears

Interventions

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.

Sponsors & Collaborators

  • Holy Family Hospital, Methuen, MA

    collaborator OTHER

  • Erika Carmel ltd

    lead OTHER

Principal Investigators

  • Marwan Hadad, MD · Department of Orthopedic Surgery, Holy Family Hospital, Nazareth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-26
Primary Completion
2022-03-25
Completion
2022-04-11

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04593342 on ClinicalTrials.gov