Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair (LLL&RotC01)

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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Device: Sham; Device: B-Cure Pro

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Nazareth, Israel
    • Holy Family Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 40-65
• Men or women
• Full or partial rotator cuff tear
• Scheduled to undergo RCAS because of failure of conservative therapy (injections, medication, physiotherapy)
• Is willing to perform the full protocol
• Voluntarily sign and date an informed consent form
• Be able to understand and complete the various questionnaires

Exclusion Criteria:

• Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits
• Participation in another clinical study within 30 days before screening
• Scheduled to undergo an elective medical procedure during the study timeframe that will interfere with the study as deemed by the PI
• Pregnant
• Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for shoulder pain
• Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light
• Has osteoarthritis
• Other chronic pain conditions: fibromyalgia, failed back surgery, back pain
• Avascular necrosis
• Rheumatoid arthritis
• Psychiatric disorders including major depression, schizophrenia, bipolar disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard + B-Cure Pro; Subjects from the Standard + B-Cure Pro group will receive standard care and in addition will self-treat at home with the B-Cure device	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.
Sham Comparator: Standard + Sham; Subjects from the Standard + Sham group will receive standard care and in addition will self-treat at home with the sham B-Cure device	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in level of pain by VAS	Subject assessment of pain will be evaluated using a Visual Analogue Scale (VAS), were 0 is "no pain" and 100 is "intolerable pain".	1 month post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in functionality (CONSTANT score)	The CONSTANT score used to assess the functionality of the shoulder by clinicians. The range of the score is 0-100. The higher the score, the higher the quality of the function.	1 month post-surgery

Collaborators and Investigators

• Sponsor: Erika Carmel ltd
• Collaborators: Holy Family Hospital, Methuen, MA
• Investigators: Principal Investigator: Marwan Hadad, MD, Department of Orthopedic Surgery, Holy Family Hospital, Nazareth

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2020
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Photobiomodulation; Low-Level Laser Therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: HFH-219-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No