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 | Not Yet Recruiting Phase 1

• 1 other identifier: 36265MD337/12/24
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Assessment of pain intensity using 10-point numerical rating scale (NRS-10)

  immediately after intervention , 1 week,1month,3 months,6months and one year.

Secondary Outcomes (2)

• Assessment of Knee function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  immediately after intervention , 1 week,1month,3 months,6months and one year.

• 2- Assessment of the side effects and complications of these methods as (paresthesia, motor deficits, pain during application and increase in pain)

  immediately after intervention , 1 week,1month,3 months,6months and one year.

Study Arms (3)

Radiofrequency ablation group

EXPERIMENTAL

Device: radiofrequency ablation

Alcohol injection group

EXPERIMENTAL

Drug: alcohol neurolysis

Phenol injection group

EXPERIMENTAL

Drug: phenol neurolysis

Interventions

radiofrequency ablation DEVICE

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

Radiofrequency ablation group

phenol neurolysis DRUG

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

Phenol injection group

alcohol neurolysis DRUG

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

Alcohol injection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Radiofrequency Ablation; Ethanol

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Alcohols; Organic Chemicals

Central Study Contacts

Tanta University

CONTACT

0020403317928; support_net@unv.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gomakarem

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 29, 2025

Record last verified: 2025-01