Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair

NCT04593342 | Completed DMC

• 1 other identifier: HFH-219-2020
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Keywords

Photobiomodulation; Low-Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in functionality (CONSTANT score)

  1 month post-surgery

Study Arms (2)

Standard + B-Cure Pro

ACTIVE COMPARATOR

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

Standard + Sham

SHAM COMPARATOR

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

Interventions

B-Cure Pro DEVICE

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.

Standard + B-Cure Pro

Sham DEVICE

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.

Standard + Sham

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erika Carmel ltd: lead
• Holy Family Hospital, Methuen, MA: collaborator

Study Sites (1)

Holy Family Hospital

Nazareth, Israel

Location

Related Publications (1)

• Abufoul R, Gavish L, Haddad M. Photobiomodulation self-treatment at home after rotator cuff arthroscopic repair accelerates improvement in pain, functionality, and quality of life: A double-blind, sham-controlled, randomized clinical trial. Lasers Surg Med. 2023 Sep;55(7):662-673. doi: 10.1002/lsm.23692. Epub 2023 Jun 8.

  PMID: 37288499 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Marwan Hadad, MD

  Department of Orthopedic Surgery, Holy Family Hospital, Nazareth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sham control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: November 26, 2020
• Primary Completion: March 25, 2022
• Study Completion: April 11, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)