Rotator Cuff Tears
Conditions
Keywords
Photobiomodulation, Low-Level Laser Therapy
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.
Interventions
DEVICEB-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.
DEVICESham
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
Holy Family Hospital, Methuen, MA
Erika Carmel ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Sham control
Intervention model description
Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in level of pain by VAS | 1 month post-surgery | Subject assessment of pain will be evaluated using a Visual Analogue Scale (VAS), were 0 is no pain and 100 is intolerable pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in functionality (CONSTANT score) | 1 month post-surgery | 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. |
Countries
Israel
Outcome results
None listed