The Effect of Therapeutic Methods for Chronic Knee Osteoarthritis Pain

Osteoarthritis, Knee Clinical Trial

Official title:

Phase 1 Study of Therapeutic Methods for Chronic Knee Osteoarthritis Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924677
• Other study ID #: GN0901
• Status: Completed
• Phase: N/A
• First received: June 18, 2009
• Last updated: June 18, 2009
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• 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.
• radiofrequency neurotomy sham therapy
The placebo (sham) group received the same procedure without activation of the RF generator.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale pain scores		at 12 weeks after the procedure
Secondary	Oxford knee score		at 12 weeks after the procedure