Osteoarthritis Of Knee
Conditions
Keywords
Osteoarthritis, Knee Osteoarthritis
Brief 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 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.
Interventions
DEVICEB-Cure laser pro
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.
DEVICESham
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
Sponsors
Barzilai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Sham control
Intervention model description
Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR) 2. Kellgren & Lawrence classification 1-3 3. Knee pain on movement 40 to 90 mm Visual Analog Scale 4. Knee pain and related functional reduction for at least 1 month
Exclusion criteria
1. Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control 2. Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations. 3. Knee surgery for KOA 4. Intra-articular steroid injection and/or oral steroid treatment within the last six months 5. Rheumatoid arthritis 6. Symptomatic OA in other joints (i.e. hip, hand) 7. Use of narcotics on the day of evaluation 8. Active malignancy 9. Uncontrolled diabetes mellitus 10. Neurological conditions: sciatica, neuropathy, multiple sclerosis 11. Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain 12. Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain 13. Has known dermatological sensitivity to light 14. Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in level of pain by VAS | 1month | Subject assessment of pain will be evaluated using a Visual Analogue Scale (VAS), were 0 is no pain and 100 is intolerable pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in WOMAC score | 1 month | 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. |
Countries
Israel
Contacts
Primary ContactGalia Cohen Peres, BA
Outcome results
None listed