Knee OsteoarthritisPBM&KOA-02NCT05357703
Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis
A study testing Standard treatment + Active B-Cure laser in people with Knee Osteoarthritis, run by Erika Carmel ltd 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
- Knee Osteoarthritis
- What is being tested?
- Standard treatment + Active B-Cure laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 26 May 2022to 15 Aug 2023
- 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 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 2-3
- Knee pain on movement 40 to 90 mm Visual Analog Scale
- Knee pain and related functional reduction for the last ≥ 3 months
- Agrees not to use NSAIDs throughout the experiment
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
- Active malignancy
Show all 13Show fewer
- 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.
Israel1 site, 1 recruiting
- Recruiting
Holy Family Hospital
Nazareth
Jehad Khazen, MD, 972545600095, khazenjehad@gmail.com
Maroun Yacoub, +9720543349738 ext. +9720543349738, maroun@gd-energies.com
About this study
Official title: Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: An Open Label, Single-Arm Clinical Trial
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 B-Cure laser treatments, 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
Eligible patients with knee osteoarthritis will receive a B-Cure laser device for self-application at home in addition to standard care. Patients will be invited to the clinic for 3 visits: baseline, 1, and 2 months. Evaluations at the visits will include physical examination, knee range of motion, time up\&go test, and patient reported outcomes including subjective pain level by visual analogue scale (VAS), functional and quality of life questionnaires.
The study hypothesis is that B-Cure laser treatments, applied, at home, by the patient, can ameliorate KOA related inflammation thereby reducing pain and improving functionality in these patients.
- Conditions
- Knee Osteoarthritis
- Being tested
- Standard treatment + Active B-Cure laser
- Keywords
- Photobiomodulation, Low-Level Laser Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatment + Active B-Cure laserDevice
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 5J/minute.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment + Active B-Cure laser | Experimental | Subjects from Standard treatment + Active B-Cure laser will receive standard care and in addition will self-treat at home with the B-Cure device. Receives: Device: Standard treatment + Active B-Cure laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of pain
Change from baseline in pain score by VAS
Measured: one month
Secondary outcomes (1)
Change from baseline in WOMAC score [ time point - 1 month]
The WOMAC is a disease-specific tool used for people with hip or knee OA to measure physical function, pain, and stiffness. It widely used in clinical studies as primary or secondary outcome.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start26 May 2022 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erika Carmel ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Holy Family Hospital, Nazareth, Israel
- Responsible party
- Sponsor
- Investigators
- Marwan Hadad, MD, Principal investigator, The Holy Family Hospital, Nazareth, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357703
- Sponsor's protocol ID
- HFH-256-2022
- Acronym
- PBM&KOA-02
- Status last verified
- Apr 2022
- First submitted
- 27 Apr 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. 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: An Open Label, Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT05357703
- Acronym / sponsor ID
- PBM&KOA-02 / HFH-256-2022
- Conditions
- Knee Osteoarthritis
- Keywords
- Photobiomodulation, Low-Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Erika Carmel ltdUniversity, hospital or other
- Collaborators
- Holy Family Hospital, Nazareth, Israel
- Study start
- 26 May 2022 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 3 May 2022 (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 B-Cure laser treatments, 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
Eligible patients with knee osteoarthritis will receive a B-Cure laser device for self-application at home in addition to standard care. Patients will be invited to the clinic for 3 visits: baseline, 1, and 2 months. Evaluations at the visits will include physical examination, knee range of motion, time up\&go test, and patient reported outcomes including subjective pain level by visual analogue scale (VAS), functional and quality of life questionnaires.
The study hypothesis is that B-Cure laser treatments, applied, at home, by the patient, can ameliorate KOA related inflammation thereby reducing pain and improving functionality in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard treatment + Active B-Cure laser | Experimental | Device: Standard treatment + Active B-Cure laserSubjects from Standard treatment + Active B-Cure laser will receive standard care and in addition will self-treat at home with the 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 (5 listed)
- Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)
- Kellgren \& Lawrence classification 2-3
- Knee pain on movement 40 to 90 mm Visual Analog Scale
- Knee pain and related functional reduction for the last ≥ 3 months
- Agrees not to use NSAIDs throughout the experiment
Key exclusion criteria (13 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 |
|---|---|---|
| Standard treatment + Active B-Cure laserThe 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 5J/minute. | Device | Standard treatment + Active B-Cure laser |
Primary outcome
level of pain
Time frame: one month
Change from baseline in pain score by VAS
1 secondary outcome
Change from baseline in WOMAC score [ time point - 1 month]
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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
The Holy Family Hospital, Nazareth, 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 Standard treatment + Active B-Cure laser in people with Knee Osteoarthritis, 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 1 Jun 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jehad Khazen, MD (+972545600095, khazenjehad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of pain (time frame: one month). 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 1 Jun 2022.