NCT00924677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2009

Completed
Last Updated

June 19, 2009

Status Verified

June 1, 2009

Enrollment Period

3 months

First QC Date

June 18, 2009

Last Update Submit

June 18, 2009

Conditions

Osteoarthritis, Knee

Keywords

genicular nerveosteoarthritiskneeneurotomy

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale pain scores

    at 12 weeks after the procedure

Secondary Outcomes (1)

  • Oxford knee score

    at 12 weeks after the procedure

Study Arms (2)

lidocaine

SHAM COMPARATOR

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

Procedure: radiofrequency neurotomy sham therapy

lidocaine, radiofrequency current

ACTIVE COMPARATOR

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

Procedure: radiofrequency neurotomy for genicular nerve

Interventions

radiofrequency neurotomy for genicular nervePROCEDURE

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.

Also known as: neuroablation or radiofrequency neurolysis
lidocaine, radiofrequency current
radiofrequency neurotomy sham therapyPROCEDURE

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

Also known as: radiofrequency neurolysis sham therapy
lidocaine

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

Related 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. doi: 10.1177/036354658201000601.

    PMID: 6897495BACKGROUND

  • 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.

    PMID: 10515020RESULT

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Denervation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Pyong-hwan Park, M.D.

    Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 19, 2009

Study Start

January 1, 2009

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

June 19, 2009

Record last verified: 2009-06

Locations

KR(1)