Clinical trial NCT04593342: Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: Photobiomodulation
Low-Level Laser Therapy
Lead sponsor: Erika Carmel ltd
Sponsor class: OTHER
Collaborators: name: Holy Family Hospital, Methuen, MA
First posted: 2020-10-20
Enrollment: 53
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in level of pain by VAS
timeFrame: 1 month post-surgery
Secondary outcomes:
measure: Change from baseline in functionality (CONSTANT score)
timeFrame: 1 month post-surgery
Other outcomes:
Locations:
city: Nazareth
country: Israel
facility: Holy Family Hospital
Study officials:
affiliation: Department of Orthopedic Surgery, Holy Family Hospital, Nazareth
name: Marwan Hadad, MD
role: PRINCIPAL_INVESTIGATOR
References: