Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair

Rotator Cuff Tears Clinical Trial

— LLL&RotC01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593342
• Other study ID #: HFH-219-2020
• Status: Completed
• Phase: N/A
• Start date: November 26, 2020
• Est. completion date: April 11, 2022

Study information

• Verified date: April 2022
• Source: Erika Carmel ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 11, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

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
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.

Locations

Country	Name	City	State
Israel	Holy Family Hospital	Nazareth

Sponsors (2)

Lead Sponsor	Collaborator
Erika Carmel ltd	Holy Family Hospital, Methuen, MA

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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