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

Primary Purpose

Rotator Cuff Tears

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
B-Cure Pro
Sham
Sponsored by
Erika Carmel ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Photobiomodulation, Low-Level Laser Therapy

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Holy Family Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Standard + B-Cure Pro

Standard + Sham

Arm 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

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

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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.

Full Information

First Posted
October 13, 2020
Last Updated
April 27, 2022
Sponsor
Erika Carmel ltd
Collaborators
Holy Family Hospital, Methuen, MA
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1. Study Identification

Unique Protocol Identification Number
NCT04593342
Brief Title
Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 26, 2020 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erika Carmel ltd
Collaborators
Holy Family Hospital, Methuen, MA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
Photobiomodulation, Low-Level Laser Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
Masking
ParticipantOutcomes Assessor
Masking Description
Sham control
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard + B-Cure Pro
Arm Type
Active Comparator
Arm 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
Arm Title
Standard + Sham
Arm Type
Sham Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
B-Cure Pro
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in level of pain by VAS
Description
Subject assessment of pain will be evaluated using a Visual Analogue Scale (VAS), were 0 is "no pain" and 100 is "intolerable pain".
Time Frame
1 month post-surgery
Secondary Outcome Measure Information:
Title
Change from baseline in functionality (CONSTANT score)
Description
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.
Time Frame
1 month post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwan Hadad, MD
Organizational Affiliation
Department of Orthopedic Surgery, Holy Family Hospital, Nazareth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holy Family Hospital
City
Nazareth
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair

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