Osteoarthritis Of KneeNCT06773676
Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis
A study testing B-Cure laser pro in people with Osteoarthritis Of Knee, run by Barzilai Medical Center at 1 site in Israel.
Trial summary
Osteoarthritis is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. Photobiomodulation (PBM), has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing, and particularly to treat knee… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoarthritis Of Knee
- What is being tested?
- B-Cure laser pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Jan 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)
- Kellgren \& Lawrence classification 1-3
- Knee pain on movement 40 to 90 mm Visual Analog Scale
- Knee pain and related functional reduction for at least 1 month
Who cannot join
- Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
- Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations.
- Knee surgery for KOA
- Intra-articular steroid injection and/or oral steroid treatment within the last six months
- Rheumatoid arthritis
- Symptomatic OA in other joints (i.e. hip, hand)
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- Use of narcotics on the day of evaluation
- Active malignancy
- Uncontrolled diabetes mellitus
- Neurological conditions: sciatica, neuropathy, multiple sclerosis
- Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain
- Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain
- Has known dermatological sensitivity to light
- Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Barzilai University Medical Center
Ashkelon, Southern District, 7830604
About this study
Official title: Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Double-Blind, Randomized, Sham-Controlled Clinical Study
Osteoarthritis is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. Photobiomodulation (PBM), has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing, and particularly to treat knee osteoarthritis (KOA). The purpose of the current study is to determine if a near-infrared PBM device (B-Cure Laser), applied at home, by the patient or personal caregiver in a real-life situation, can reduce pain and improve functionality in patients with KOA.
Read the detailed description
This is a prospective double blind randomized sham-controlled clinical trial. Eligible participants with KOA will be randomly allocated to receive active or sham devices for self-treatment at home in addition to standard care. Patients will be invited to the clinic for 3 visits: baseline, 1 month, and 3 months. Evaluations will include physical examination, range of motion, and patient reported outcomes including subjective pain level by visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and quality of life questionnaire (SF-12). Participants will document treatments and analgesic-drug use in a diary.
The study hypothesis is that B-Cure laser treatments, applied at home by the patient, can reduce pain and improve functionality compared to standard care alone.
- Conditions
- Osteoarthritis Of Knee
- Being tested
- B-Cure laser pro, Sham
- Keywords
- Osteoarthritis, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-Cure laser proDevice
The B-Cure laser pro is a portal, non-invasive, photobiomodulation 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 1J/cm2.
ShamDevice
The sham device is externally identical to active, emits the same guiding light and sound but does not emit the therapeutic near infrared invisible 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 laser 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: 1month
Secondary outcomes (1)
Change from baseline in WOMAC score
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a disease-specific self-administered questionnaire used to assess the severity of symptoms and functional limitations in individuals with hip or knee osteoarthritis (OA). It consists of 24 items, each scored on a scale of 0-4. Higher scores indicate worse pain, stiffness, and functional limitations.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start14 Jan 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis Of KneeStudies 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
- Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omri Lubovsky, Barzilai Medical Center
- Investigators
- Omri Lubovsky, MD, Principal investigator, Barzilai University Medical Center Ashkelon Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773676
- Sponsor's protocol ID
- 0019-22-BRZ
- Other IDs
- MOH_2024-12-09_013784
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Double-Blind, Randomized, Sham-Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06773676
- Acronym / sponsor ID
- 0019-22-BRZ
- Conditions
- Osteoarthritis Of Knee
- Keywords
- Osteoarthritis, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- 14 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 14 Jan 2025 (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.
Osteoarthritis is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. Photobiomodulation (PBM), has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing, and particularly to treat knee osteoarthritis (KOA). The purpose of the current study is to determine if a near-infrared PBM device (B-Cure Laser), applied at home, by the patient or personal caregiver in a real-life situation, can reduce pain and improve functionality in patients with KOA.
Detailed description
This is a prospective double blind randomized sham-controlled clinical trial. Eligible participants with KOA will be randomly allocated to receive active or sham devices for self-treatment at home in addition to standard care. Patients will be invited to the clinic for 3 visits: baseline, 1 month, and 3 months. Evaluations will include physical examination, range of motion, and patient reported outcomes including subjective pain level by visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and quality of life questionnaire (SF-12). Participants will document treatments and analgesic-drug use in a diary.
The study hypothesis is that B-Cure laser treatments, applied at home by the patient, can reduce pain and improve functionality compared to standard care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
| Arm | Type | Receives |
|---|---|---|
| Standard + B-Cure Pro | Active comparator | Device: B-Cure laser 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
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)
- Kellgren \& Lawrence classification 1-3
- Knee pain on movement 40 to 90 mm Visual Analog Scale
- Knee pain and related functional reduction for at least 1 month
Key exclusion criteria (14 listed)
- Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
- Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations.
- Knee surgery for KOA
- Intra-articular steroid injection and/or oral steroid treatment within the last six months
- Rheumatoid arthritis
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 laser proThe B-Cure laser pro is a portal, non-invasive, photobiomodulation 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 1J/cm2. | Device | Standard + B-Cure Pro |
| ShamThe sham device is externally identical to active, emits the same guiding light and sound but does not emit the therapeutic near infrared invisible rays | Device | Standard + Sham |
Primary outcome
Change from baseline in level of pain by VAS
Time frame: 1month
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 WOMAC score
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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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.
Omri Lubovsky, MD principal investigator
Barzilai University Medical Center Ashkelon Israel
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 laser pro in people with Osteoarthritis Of Knee, run by Barzilai Medical Center 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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 14 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galia Cohen Peres, BA (+972-54-2211779, cohenperesg@bmc.gov.il), or a site near the patient. 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: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2025.