PBM&KOA-02Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: An Open Label, Single-Arm Clinical Trial
Standard treatment + Active B-Cure laser
Arthritis+3
+ Joint Diseases
+ Musculoskeletal Diseases
Treatment Study
Summary
Study start date: May 26, 2022
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 50 to 90 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR) 2. Kellgren \& Lawrence classification 2-3 3. Knee pain on movement 40 to 90 mm Visual Analog Scale 4. Knee pain and related functional reduction for the last ≥ 3 months 5. Agrees not to use NSAIDs throughout the experiment 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. Active malignancy 7. Uncontrolled diabetes mellitus 8. Neurological conditions: sciatica, neuropathy, multiple sclerosis 9. Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain 10. Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain 11. Has known dermatological sensitivity to light 12. Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial. \-
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location