The Effect of Therapeutic Methods for Chronic Knee Osteoarthritis Pain

NCT ID: NCT00924677

Last Updated: 2009-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

lidocaine

Local injection with lidocaine through the RF cannula without activation of RF generator.

Group Type: SHAM_COMPARATOR

radiofrequency neurotomy sham therapy

Intervention Type: PROCEDURE

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

lidocaine, radiofrequency current

After lidocaine injection through the RF cannula, the temperature of the electrode tip was raised to 70℃ for 90 seconds by RF generator.

Group Type: ACTIVE_COMPARATOR

radiofrequency neurotomy for genicular nerve

Intervention Type: 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.

Interventions

radiofrequency neurotomy for genicular nerve

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.

Intervention Type: PROCEDURE

radiofrequency neurotomy sham therapy

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

Intervention Type: PROCEDURE

Other Intervention Names

neuroablation or radiofrequency neurolysis; radiofrequency neurolysis sham therapy

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

anesthesiology and pain medicine

Principal Investigators

Pyong-hwan Park, M.D.

Role: STUDY_CHAIR

Asan Medical Center

Locations

Asan Medical Center, University of Ulsan College of Medicine

Seoul, , South Korea

Countries

South Korea

References

Kennedy JC, Alexander IJ, Hayes KC. Nerve supply of the human knee and its functional importance. Am J Sports Med. 1982 Nov-Dec;10(6):329-35. doi: 10.1177/036354658201000601.

Reference Type: BACKGROUND

PMID: 6897495 (View on PubMed)

van Kleef M, Barendse GA, Kessels A, Voets HM, Weber WE, de Lange S. Randomized trial of radiofrequency lumbar facet denervation for chronic low back pain. Spine (Phila Pa 1976). 1999 Sep 15;24(18):1937-42. doi: 10.1097/00007632-199909150-00013.

Reference Type: RESULT

PMID: 10515020 (View on PubMed)

Other Identifiers

GN0901

Identifier Type: -

Identifier Source: org_study_id