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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

NCT06798038 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-01-29

No results posted yet for this study

Summary

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.

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

Interventions

DEVICE

radiofrequency ablation

35 Patients will be undergo for radiofrequency ablation which will be applied to each genicular nerve.

DRUG

phenol neurolysis

35 Patients will be administered with 2.0 ml of 6% phenol solution prepared from crystallized phenol per genicular nerve

DRUG

alcohol neurolysis

35 Patients will be administered with 1.0ml of 70% alcohol per genicular nerve

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-02-28
Completion
2027-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798038 on ClinicalTrials.gov