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H-Wave® Device Stimulation for Chronic Knee Pain Disorders: A Patient-Reported Outcome Measures Observational Study.

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  • 1Future Biologics, Lawrenceville, GA 30043, USA.

Medicina (Kaunas, Lithuania)
|January 28, 2026
PubMed
Summary

H-Wave® device stimulation (HWDS) shows promising results for chronic knee pain (cKP) patients, improving function, pain, and sleep quality. This study suggests HWDS may benefit those with knee injuries or degeneration, with high patient satisfaction.

Keywords:
H-Wave device stimulationH-Wave®PROMschronic painelectrical stimulationkneeknee osteoarthritisosteoarthritispatient-reported outcome measures

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Area of Science:

  • Pain Management
  • Neuromodulation
  • Rehabilitation Medicine

Background:

  • Chronic knee pain (cKP) affects 25% of adults globally, with increasing prevalence.
  • Conventional treatments have limitations; electrical stimulation shows potential for improving quality of life.
  • Existing literature lacks adequate patient-reported outcome measures (PROMs) for electrical stimulation in cKP.

Purpose of the Study:

  • To assess the efficacy of H-Wave® device stimulation (HWDS) in patients with various knee disorders using PROMs.
  • To evaluate HWDS impact on function, pain, sleep, medication needs, work ability, and patient satisfaction.
  • To analyze preliminary PROMs data for HWDS in cKP, building on prior studies for other pain regions.

Main Methods:

  • Retrospective, observational cohort study analyzing prospectively collected H-Wave® PROMs data over 4 years.
  • Screened 34,192 patient surveys for individuals (≥18 years) with knee disorders, chronic pain (90-730 days), and HWDS treatment (22-365 days).
  • PROMs assessed effects on function, pain, sleep, medication, work, and satisfaction; data included demographics, pain chronicity, and device usage.

Main Results:

  • Analysis of 1143 (all knee), 985 (knee injury), and 124 (knee degeneration) cases showed significant improvements in function/ADL (96.51%) and work performance (84.63%).
  • 86.76% reported ≥20% pain relief, with an average reduction of 2.96 points (0-10 NRS).
  • Medication use decreased (69.85%), sleep improved (55.33% in knee injury), and patient satisfaction exceeded 96% across subgroups.

Conclusions:

  • HWDS PROMs data indicate encouraging outcomes for chronic knee pain patients, similar to other body regions.
  • Knee injury and degeneration subgroups experienced comparable benefits from HWDS.
  • Despite limitations, HWDS shows potential benefits for refractory cKP patients, warranting further investigation.