Back to resultsEvaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Prospective Double Blind, Randomized, Sham-Controlled Clinical Study
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
B-Cure laser pro
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Diagnoses of knee osteoarthritis:( American College of Rheumatology (ACR) criteria (see below) - possibilities:ACR1: Fulfilled at least one of the classification criteria of the American College of Rheumatology ACR2: KOA verified with the American College of Rheumatology criteria using a history and physical examination, i.e. knee pain and at least three of the following: 50-85 years old, ≤ 30 minutes of morning stiffness, crepitus on active range of motion, bony tenderness, bony enlargement, and no palpable warmth of synovia Radiographic evidence of knee osteoarthritis between 2-3 in Kellgren and Lawrence classification
- KOA grade 2-3
- Knee pain on movement 40 to 90 mm Visual Analog Scale
- Knee pain for the last ≥ 3 months
- Functional reduction in the last three months
- Agrees not to use NSAIDs throughout the experiment
- Agrees not to use any other treatment (except rescue drugs) for KOA during participation in this study.
Exclusion Criteria:
- Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, 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)
- Use of analgesics on the day of evaluation
- Use of NSAIDs 2 weeks before the beginning of the treatment
- Active malignancy
- Uncontrolled diabetes mellitus
- Neurological conditions: sciatica, neuropathy, multiple sclerosis
- Other chronic pain conditions: Fibromyalgia, back pain, hip pain
- Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active LLLT
Sham LLLT
Arm Description
Patients will self-treat at home (active or sham), twice a day (excluding Weekends) for 1 month. The duration of each session will be 15-20 minutes and will include treatment over painful point on the knee and over regional lymph nodes (popliteal, inguinal). The treatment dose should be initiated gradually for the first week until reaching the maximum dose of 6-8 minutes per treatment point. This is the recommended dose for near infrared lasers for the indication of knee pain by the World Association for Laser Therapy (WALT). In the first days an increase in pain may be felt before the reduction in pain. If the increase in pain continues for more than a week under graded dosimetry, the treatment must be stopped. Laser therapy will be administered to the patients in addition to standard of care therapy as customary in our institution.
Half of the LLT devices will be not activated at random before the application to the patients. Sham activated devices will give outward signs of normal function but will not generate a signal. The investigators will be unaware of the device's functionality. The patients will not be able to determine whether the device is working or not. At study completion, device serial numbers will be used to determine which patients received a working device.
Outcomes
Primary Outcome Measures
To evaluate the effectiveness of B-cure laser for pain reduction in patients with knee osteoarthritis
Change from baseline in pain score by visual analog scale (VAS), 0-10, 0 - no pain; 10- worst pain
Secondary Outcome Measures
Range of Movement
Change from baseline
Full Information
NCT ID
NCT04276038
First Posted
February 18, 2020
Last Updated
February 20, 2020
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04276038
Brief Title
Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Prospective Double Blind, Randomized, Sham-Controlled Clinical Study
Official Title
Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Prospective Double Blind, Randomized, Sham-Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Osteoarthritis (OA) is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. The treatment of this disease remains limited to symptomatic relief and, ultimately, joint replacement. Despite the progress made in understanding the pathophysiology of OA, effective disease-modifying drugs are still lacking.
Low-level laser therapy (LLLT), also known as Photobiomodulation therapy, is a non-ionizing optical radiation in the visible or near infrared range of the spectrum. LLLI has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing. Specifically, it has been shown to reduce pain in chronic inflammatory related knee pathologies in pre-clinical and clinical studies. However, the recommended treatment protocol requires frequent treatments that translates to frequent visits at the clinic. Such a treatment regimen is difficult for Knee OA (KOA) patients and demanding of the clinical staff. Since the treatment itself can be self-applied easily, a home-use device would enable frequent treatments thereby improving patient adherence to the treatment.
In a pilot study, Kruglova et al [4] reported that 2 weeks of daily treatments with the home use B-Cure laser significantly reduced pain and increased flexibility in 20 elite athletes with 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 osteoarthritis of the knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active LLLT
Arm Type
Active Comparator
Arm Description
Patients will self-treat at home (active or sham), twice a day (excluding Weekends) for 1 month. The duration of each session will be 15-20 minutes and will include treatment over painful point on the knee and over regional lymph nodes (popliteal, inguinal). The treatment dose should be initiated gradually for the first week until reaching the maximum dose of 6-8 minutes per treatment point. This is the recommended dose for near infrared lasers for the indication of knee pain by the World Association for Laser Therapy (WALT). In the first days an increase in pain may be felt before the reduction in pain. If the increase in pain continues for more than a week under graded dosimetry, the treatment must be stopped.
Laser therapy will be administered to the patients in addition to standard of care therapy as customary in our institution.
Arm Title
Sham LLLT
Arm Type
Sham Comparator
Arm Description
Half of the LLT devices will be not activated at random before the application to the patients. Sham activated devices will give outward signs of normal function but will not generate a signal. The investigators will be unaware of the device's functionality. The patients will not be able to determine whether the device is working or not. At study completion, device serial numbers will be used to determine which patients received a working device.
Intervention Type
Device
Intervention Name(s)
B-Cure laser 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 1J/cm2. The device is used at home and is self-applied by the patient. The device is AMAR approved (approval # 14810408) for pain reduction and for ulcer treatment. The device is also approved for marketing in Canada and as a medical device in Europe (CE medical mark).
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of B-cure laser for pain reduction in patients with knee osteoarthritis
Description
Change from baseline in pain score by visual analog scale (VAS), 0-10, 0 - no pain; 10- worst pain
Time Frame
time point - 1 month
Secondary Outcome Measure Information:
Title
Range of Movement
Description
Change from baseline
Time Frame
time point - 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnoses of knee osteoarthritis:( American College of Rheumatology (ACR) criteria (see below) - possibilities:ACR1: Fulfilled at least one of the classification criteria of the American College of Rheumatology ACR2: KOA verified with the American College of Rheumatology criteria using a history and physical examination, i.e. knee pain and at least three of the following: 50-85 years old, ≤ 30 minutes of morning stiffness, crepitus on active range of motion, bony tenderness, bony enlargement, and no palpable warmth of synovia Radiographic evidence of knee osteoarthritis between 2-3 in Kellgren and Lawrence classification
KOA grade 2-3
Knee pain on movement 40 to 90 mm Visual Analog Scale
Knee pain for the last ≥ 3 months
Functional reduction in the last three months
Agrees not to use NSAIDs throughout the experiment
Agrees not to use any other treatment (except rescue drugs) for KOA during participation in this study.
Exclusion Criteria:
Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, 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)
Use of analgesics on the day of evaluation
Use of NSAIDs 2 weeks before the beginning of the treatment
Active malignancy
Uncontrolled diabetes mellitus
Neurological conditions: sciatica, neuropathy, multiple sclerosis
Other chronic pain conditions: Fibromyalgia, back pain, hip pain
Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reut Wengier
Phone
36974720
Ext
972
Email
reutw@tlvmc.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Prospective Double Blind, Randomized, Sham-Controlled Clinical Study
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