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NCT Number: NCT00924677

The Effect of Therapeutic Methods for Chronic Knee Osteoarthritis Pain

Chronic osteoarthritis (OA) pain of the knee is not effectively abrogated by the available non-pharmacologic or pharmacologic treatments. Radiofrequency (RF) neurotomy is a therapeutic alternative for chronic pain. Here, the researchers investigate the efficacy of RF neurotomy applied to articular branches (genicular nerves) in treating knee joint pain.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

About this study

The knee joint is innervated by articular branches of various nerves (femoral, common peroneal, saphenous, tibial and obturator) (Kennedy et al. 1982; Hirasawa et al. 2000). These articular branches around the knee joint are known as genicular nerves. Several genicular nerves can be easily approached percutaneously under fluoroscopic guidance. In our study, genicular nerves were effectively blocked with local anesthetics under fluoroscopic guidance, leading to a significant reduction in knee pain. Rf neurotomy is based on the theory that cutting the nerve supply to a painful structure may alleviate pain and restore function. we evaluate the efficacy of RF neurotomy in reducing pain and improving function in the elderly with chronic knee OA.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients with chronic knee pain (i.e., knee pain of moderate intensity or greater on most or all days for ≥ 3 months)
  • patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, evaluated by a radiologist)

Exclusion criteria

  • acute knee pain
  • prior knee surgery
  • other connective tissue diseases affecting the knee
  • serious neurologic or psychiatric disorders
  • injection with steroids or hyaluronic acids during the previous 3 months
  • sciatic pain
  • anticoagulant medications
  • pacemakers
  • prior electroacupuncture treatments

Treatment and study plan

radiofrequency neurotomy for genicular nerve

Procedure

RF cannula was advanced percutaneously towards areas connecting the shaft to epicondyle of femur or tibia. Lidocaine (1 mL of 2%) was injected before activation of the RF generator (NeuroThermTM, Morgan automation LTD, Liss, UK). RF electrode was inserted through RF cannula. The temperature of the electrode tip was raised to 70℃ for 90 seconds by radiofrequency generator.

Other names: neuroablation or radiofrequency neurolysis

radiofrequency neurotomy sham therapy

Procedure

The placebo (sham) group received the same procedure without activation of the RF generator.

Other names: radiofrequency neurolysis sham therapy

Primary outcomes

  1. Visual analogue scale pain scores

    Time frame: at 12 weeks after the procedure

Secondary outcomes

  1. Oxford knee score

    Time frame: at 12 weeks after the procedure

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Phase 1 Study of Therapeutic Methods for Chronic Knee Osteoarthritis Pain

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 19, 2009
Registry last updated
Jun 19, 2009

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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