Laser Needling® and Natural origin, Highly Purifi ed Polynucleotides (PN-HPT™) in Knee Osteoarthrosis: Benefi ts in Physiatry and Sports Medicine

Abstract

Background and Objectives: The purpose of the paper is to illustrate the real life clinical outcomes of a retrospective cohort of knee Osteoarthritis (OA) patients treated with a novel laser disease management program; at the same time, to defi ne the most effective operative procedure. The new laser technique mimics the in-vitro benefi ts of Low-Level Laser Therapies (LLLT). The study compared the 3month effi cacy and 6-month persistence of clinical and functional benefi ts after application of laser energy either externally with a standard High Power Laser Therapy (HPLT) laser device (AG1 device, FP3 version), or intra-articularly with the patented, low-energy AG8 intra articular fi ber device (ultrasound-guided, same wavelengths, no handpiece). This innovative laser device reduces to one hundredth the applied energy density. The pain suppressing effi cacy of the LLLT-like laser FP3 procedure is intended to act synergically with the strong biorestructuring and pain suppressing effi cacy of natural origin polynucleotides (PN-HPT™ or Highly Purifi ed Technology™) injected before the laser session. PN-HPT™ are widely used in knee OA management for their persistent viscosupplementation properties overlapping those of high molecular weight hyaluronic acid. Trial design: retrospective comparison of:  Short term 3 month effi cacy outcomes on pain and disability  6-month persistence of clinical improvements in two cohorts of patients with severe knee osteoarthritis. The active cohort knee OA patients (105 agonistic or recreative practitioners with persistent knee pain and disability resistant to conventional medical or physical therapies) were treated with an innovative intra articular low-energy AG8 physical therapy protocol (ambulatory “AG8 Protocol 3” combined with a preliminary PN-HPT™ knee injection); the control-cohort patients (109 patients with knee disease of similar severity) were treated with a standard, multi frequency HPLT ambulatory treatment protocol (FP3 device). Outcome parameters: Western Ontario and McMaster Universities (WOMAC) assessments at baseline (T0) and after 2 weeks (T2) and 3 months (T3). Secondary parameters: Nociceptive and neuropathic pain; assessment: standard 10 cm Visual Analogue Scale (VAS) immediately before and at the end of each treatment session. Results: Treatment with the AG8 protocol 3 / PN-HPT™ intra articular combination was associated with strongly signifi cant short term (2 weeks) and medium-term (3 months) benefi ts vs. controls treated with a conventional FP3 extra-articular treatment protocol both for the WOMAC Total Score and WOMAC Pain and Function subscores. Benefi ts for the WOMAC Stiffness subscore were borderline non-signifi cant. The subgroup analysis showed that the 2A (Grade-2 KL primary OA) and 2B (Grade-2 KL secondary (post-surgical) OA) mainly contributed to overall benefi ts. Conclusion: The study showed the intra-articular Laser Needling® technique (ultrasound-guided AG8 laser device, Protocol 3 plus infi ltration of a facilitating agent such as intra-articular PN-HPT™ gel) to be more effective on knee OA pain than the traditional extra-articular FP3 laser technique, with special reference to pain associated with primary OA.