Comparison of the Efficacy of Chemical Genicular Nerve Neurolysis Using Alcohol or Phenol Versus Radiofrequency Ablation Under Ultrasound Guidance for Pain Management in Patients With Knee Osteoarthritis

Tanta University

Status and phase: Not yet enrolling; Phase 1

Conditions: Assessment of Pain Intensity Using 10-point Numerical Rating Scale (NRS-10)(9)Immediately After Intervention , 1 Week,1month,3 Months,6months and One Year; Assessment of Knee Function Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); Knee Osteoarthritis

Treatments: Drug: phenol neurolysis; Drug: alcohol neurolysis; Device: radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06798038

36265MD337/12/24

Details and patient eligibility

About

Chronic knee pain is a common condition that affects many people, particularly those with knee osteoarthritis. It can limit mobility, reduce the quality of life, and increase the risk of falling .

There are various treatment options for chronic knee osteoarthritis pain, including medications, physical therapy and surgery. Topical and oral analgesic medications and physical therapy, are often used in this population but with variable success and often wanting pain relief over time as the condition progresses.

Patients who fail medical treatment often undergo total knee arthroplasty (TKA) However, there are significant comorbidities associated with TKA, and most of patients suffer with chronic knee pain after this surgery Furthermore, a subset of patients are unable to undergo TKA because of medical comorbidities.

One alternative treatment option is genicular nerve ablation, which involves destroying nerves that carry pain signals from the knee joint to the brain. Genicular nerve ablation can be performed using radiofrequency ablation (RFA) or chemical agents such as phenol. Both methods aim to provide long-term pain relief and functional improvement in patients with chronic knee pain(4).

Chemical neurolytics, such as alcohol or phenol, have come to the fore because of their low cost and ease of application compared to radiofrequency ablation.These methods can be easily applied with ultrasound (US) guidance, which allows precise targeting of the relevant nerves. However, there is a lack of literature on appropriate agents and dose selection issues .

Radiofrequency neurolysis (RFN) of the genicular nerves, which provides innervation to the capsule of the knee joint, as well as to the intra-articular and extra-articular ligaments, have been of considerable interest as an effective technique to alleviated knee osteoarthritis pain .However, it requires expensive specialized equipment and trained personnel, which may not be available or affordable in some settings.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The following will be the criteria for inclusion, (105) patients older than 18 years with moderate to severe knee pain due to knee osteoarthritis (pain of intensity six or more on a numeric rating scale [NRS], persistent pain for more than six months, grade III or IV osteoarthritis in the radiological Kellgren-Lawrence (KL) classification (5-11), and failure to manage pain with conservative methods such as analgesics, intra-articular injection, and physical therapy.

Exclusion criteria

• • Patients' refusal to participate in the study.

  • History of intra-articular injection within three months before or after the procedure.
  • Coagulopathy and anticoagulant use.
  • Systemic disease as: renal or hepatic insufficiency.
  • Unable to communicate with the patient.
  • Implantable device.
  • Previous knee surgery.
  • Knee pain due to causes other than knee osteoarthritis (such as meniscopathy, trauma, spine disorder).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Radiofrequency ablation group

Experimental group

Treatment:

Device: radiofrequency ablation

Alcohol injection group

Experimental group

Treatment:

Drug: alcohol neurolysis

Phenol injection group

Experimental group

Treatment:

Drug: phenol neurolysis