Rotator Cuff TearsLLL&RotC01NCT04593342
Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair
A study testing B-Cure Pro in people with Rotator Cuff Tears, run by Erika Carmel ltd at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- B-Cure Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Nov 2020to 11 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Rotator Cuff Tears
- Being tested
- B-Cure Pro, Sham
- Keywords
- Photobiomodulation, Low-Level Laser Therapy
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-Cure ProDevice
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.
ShamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 1 month post-surgery
Secondary outcomes (1)
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.
Measured: 1 month post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start26 Nov 2020
- Primary completion25 Mar 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erika Carmel ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Holy Family Hospital, Methuen, MA
- Responsible party
- Sponsor
- Investigators
- Marwan Hadad, MD, Principal investigator, Department of Orthopedic Surgery, Holy Family Hospital, Nazareth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593342
- Sponsor's protocol ID
- HFH-219-2020
- Acronym
- LLL&RotC01
- Status last verified
- Apr 2022
- First submitted
- 13 Oct 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37288499
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04593342
- Acronym / sponsor ID
- LLL&RotC01 / HFH-219-2020
- Conditions
- Rotator Cuff Tears
- Keywords
- Photobiomodulation, Low-Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Erika Carmel ltdUniversity, hospital or other
- Collaborators
- Holy Family Hospital, Methuen, MA
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
| Arm | Type | Receives |
|---|---|---|
| Standard + B-Cure Pro | Active comparator | Device: B-Cure ProSubjects from the Standard + B-Cure Pro group will receive standard care and in addition will self-treat at home with the B-Cure device |
| Standard + Sham | Sham comparator | Device: ShamSubjects from the Standard + Sham group will receive standard care and in addition will self-treat at home with the sham B-Cure device |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-Cure ProThe 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. | Device | Standard + B-Cure Pro |
| ShamThe 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. | Device | Standard + Sham |
Primary outcome
Change from baseline in level of pain by VAS
Time frame: 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".
1 secondary outcome
Change from baseline in functionality (CONSTANT score)
Time frame: 1 month post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Derived from this study: PubMed 37288499Abufoul 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwan Hadad, MD principal investigator
Department of Orthopedic Surgery, Holy Family Hospital, Nazareth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-Cure Pro in people with Rotator Cuff Tears, run by Erika Carmel ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in level of pain by VAS (time frame: 1 month post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04593342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.