Efficacy of Genicular Nerve Alcohol Neurolysis in Knee Osteoarthritis Pain

Knee Pain Chronic Clinical Trial

Official title:

Evaluation of the Efficacy of Genicular Nerve Alcohol Neurolysis in the Management of Knee Osteoarthritis Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06060678
• Other study ID #: Genicular alcohol neurolysis
• Status: Completed
• Start date: May 9, 2023
• Est. completion date: November 5, 2023

Study information

• Verified date: November 2023
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aimed to evaluate the efficacy of genicular nerve alcohol neurolysis in the treatment of pain caused by chronic knee osteoarthritis. The investigators will evaluate the efficacy of genicular nerve alcohol neurolysis using the numeric rating scale (NRS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). NRS and WOMAC scores will be evaluated before, 1, and 3 months after the procedure.

Description:

Alcohol neurolysis of the genicular nerve is a procedure that involves injecting alcohol around the nerve branches that supply sensation to the knee joint. The alcohol destroys the nerve fibers and blocks the transmission of pain signals from the knee to the brain. This technique can be used to treat chronic knee pain caused by osteoarthritis (OA).

Several studies have reported that alcohol neurolysis of the genicular nerve can provide significant pain relief and functional improvement in patients with knee OA or postoperative pain. For example, Dass et al. (1) reported two cases of alcohol neurolysis of the genicular nerve using fluoroscopy and ultrasonography in patients with knee OA or persistent postsurgical pain of the knee. Both patients had more than 50% reduction in their numerical rating scale (NRS) scores and improved range of motion and quality of life at 3 months follow-up.

Ultrasonography-guided genicular nerve alcohol neurolysis is prominent with its easy applicability and low cost. There are no studies in the literature evaluating the efficacy of genicular nerve alcohol neurolysis for chronic knee OA. In this prospective study, the investigators will evaluate the NRS and WOMAC scores of patients who underwent genicular nerve alcohol neurolysis for chronic knee OA before, 1, and 3 months after the procedure. In addition, the incidence of procedure-related adverse events (such as paresthesia) recorded in patient records will be analyzed.

1. Dass RM et al. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain 2019; 32 (3): 223-227. https://www.epain.org/journal/view.html?doi=10.3344/kjp.2019.32.3.223

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 5, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Moderate to severe knee pain due to knee osteoarthritis (0-10 pain of intensity 6 and above on an inter-numeric pain scale)

• Permanent pain for more than 6 months

• Grade 3 or 4 in the radiological Kellgren-Lawrence classification having osteoarthritis

• Pain with conservative methods such as analgesics and physiotherapy treatment failure

Exclusion Criteria:

• History of intra-articular knee intervention in the last 6 months

• Cognitive impairment

• Hepatic or renal insufficiency

• Severe psychiatric illness

• Local or systemic infection

• Coagulopathy

Related Conditions & MeSH terms

• Knee Pain Chronic
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Turkey	Diskapi Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric rating scale (NRS)	Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity.	Change from Baseline NRS at 1 and 3 months
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	The WOMAC Pain score ranges from 0 to 20 with higher scores equating to greater pain with activities of daily living. The generic pain scale ranges from 0 to 10 for the OAI and 0 to 100 for MOST, with higher scores equating to greater pain	Change from Baseline WOMAC at 1 and 3 months