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This study aims to determine analgesic and anti-inflammatory effects of dual-wavelength PBM in people with symptomatic knee OA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active PBM | Active Comparator | Participants will receive active photobiomodulation (PBM) delivered to peri-articular knee sites, lumbar segments L2-L5, genicular/saphenous nerve fields, and lymphatic drainage zones using the THOR® LX2.3 device and study-specified treatment parameters. Treatment will be administered in six sessions over 2-3 weeks at a frequency of 2-3 sessions per week. |
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| Sham PBM | Sham Comparator | Participants will receive sham photobiomodulation (PBM) delivered using a visually identical THOR® LX2.3 device that does not emit therapeutic light. Sham treatment will be administered to the same anatomical sites and according to the same treatment schedule as the active PBM group, consisting of six sessions over 2-3 weeks at a frequency of 2-3 sessions per week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation therapy (PBM) device | Device | FDA-cleared near-infrared PBM device delivering therapeutic light to the affected knee. Administered once per session, approximately 10 minutes after topical application, in six sessions over 2-3 weeks (2-3 times per week). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Pain Intensity (Numeric Rating Scale) | Knee pain will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Assessments will be conducted at baseline (V0) and at the final follow-up visit, one week after the last treatment session. | Baseline (Visit 0) to Final Follow-up (Visit 7; approximately 3-4 weeks after baseline) |
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Inclusion Criteria:
Exclusion Criteria:
Systemic and Rheumatic Disease
Musculoskeletal History
Medication Use
Cardiovascular Safety
Neurological and Psychiatric Conditions
Dermatologic Conditions
Other Metabolic Conditions
Other Pain Conditions
General Health and Cognition
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Selenia Rubio, MD. MBA, | Contact | 352-273-5590 | srubio7@ufl.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
This is a small, internally funded pilot study intended to assess feasibility and preliminary outcomes. IPD sharing is not planned at this stage.
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
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| Sham PBM device | Device | Identical in appearance to the active PBM device but emits no therapeutic light. Administered once per session, approximately 10 minutes after topical application, in six sessions over 2-3 weeks. |
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