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Completed

NCT Number: NCT06060678

Efficacy of Genicular Nerve Alcohol Neurolysis in Knee Osteoarthritis Pain

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diskapi Training and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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.

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Numeric rating scale (NRS)

    Time frame: Change from Baseline NRS at 1 and 3 months

    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.

Secondary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Change from Baseline WOMAC at 1 and 3 months

    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

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2023
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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