Pulsed Radiofrequency and Osteoarthritic Chronic Knee Pain
Condition: Pulsed Radiofrequency; Osteoarthritis, Knee; Knee Pain Chronic; Knee Arthritis
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy and safety of pulsed radiofrequency
      of the saphenous nerve in the treatment of pain due to knee osteoarthritis (OA). The
      investigators will conduct real pulsed radiofrequency or sham, over the saphenous nerve
      during 4 separate sessions. The investigators will evaluate pain intensity, quality of life,
      function, and disability via clinical validated scales.

      The research question is whether pulsed radiofrequency can lessen knee pain and improve
      function and quality of life in patients with chronic knee pain due OA.

      It is hypothesized, that less knee pain and improved function, and quality of life after the
      pulsed radiofrequency sessions.
    

Detailed description: 
      Osteoarthritis (OA) affects 10% of the population over 60 years of age each year, with an
      increasing incidence related to population aging. This disease costs 1-2.5% of GDP on average
      in Europe when combining direct and indirect costs: it is therefore the 9th leading cause of
      disability adjusted life years. The knee is the most commonly affected joint, for which there
      is no treatment able to stop joint degeneration as of today: common treatment regimens
      include pharmacological therapy, joint infiltrations, neuromodulation techniques, and total
      knee arthroplasty when indicated. However, each patient responds differently and therefore
      necessitates a tailored approach.

      Pulsed radiofrequency (PRF), a neuromodulating technique that potentiates the descending
      analgesic pathway by avoiding Wallerian degeneration, has as of today been targeted
      intraarticularly or to the genicular nerves, yielding unreliable results in both cases,
      perhaps due to small samples, lack of long term follow ups, and absence of control groups.

      The goal of this study is to explore the efficacy and safety of PRF on the saphenous nerve,
      an exclusively sensory nerve that is responsible for pain perception on the medial surface of
      the lower limb, often associable with OA. In particularly, the investigators will evaluate
      the effect of PRF on pain reduction, function, disability, and quality of life in patients
      with knee OA.

      This study will include 20 participants suffering from knee OA, and the participants will
      enroll if infiltrating their saphenous nerve with 2mL of 2% lidocaine reduces their Numeric
      Pain Rating Scale (NRS) pain perception by at least 60%.

      The participants will be allocated consecutively to randomization as an intervention order
      using the tool from the randomization.com website (Dallal GE, http://www.randomization.com).
      The investigators will use the second generation suggested for crossover studies. The
      participants will be randomized into a PRF sham control group or a real PRF group and the
      investigators will follow up at 2 weeks (T1), 1 month (T2), 3 months (T3), and 6 months (T4)
      by acquiring their NRS, Oxford Knee Score, and SF-36 questionnaire. After 6 months, the
      participants will be crossed-over and the follow-up method will be repeated.
    

Intervention name(s): Pulsed Radiofrequency
Intervention type(s): Device
Intervention description(s): Pulsed radiofrequency is a novel therapeutic modality with many potential applications in pain management.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment