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

Erika Carmel

Status: Completed

Conditions: Rotator Cuff Tears

Treatments: Device: B-Cure Pro; Device: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT04593342

HFH-219-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups

Standard + B-Cure Pro

Active Comparator group

Description:

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

Treatment:

Device: B-Cure Pro

Standard + Sham

Sham Comparator group

Description:

Subjects from the Standard + Sham group will receive standard care and in addition will self-treat at home with the sham B-Cure device

Treatment:

Device: Sham