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NCT04276038
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
NA trial testing B-Cure laser pro in Knee Osteoarthritis in 52 participants. Status unknown.
1 March 2021
Quick facts
| Lead sponsor | Tel-Aviv Sourasky Medical Center |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 1 March 2020 |
| Primary completion | 1 March 2021 |
| Estimated completion | 1 March 2022 |
Drugs / interventions tested
- B-Cure laser pro
Conditions studied
- Knee Osteoarthritis — all drugs for Knee Osteoarthritis →
Sponsor
Tel-Aviv Sourasky Medical Center
Who can join
Adults 50 to 85, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04276038
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Related trials
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Trials testing the same drug.
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Other recruiting trials for Knee Osteoarthritis
Currently open trials in the same condition.
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Other Tel-Aviv Sourasky Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04276038 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tel-Aviv Sourasky Medical Center
- Last refreshed: 21 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04276038.
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