Efficacy and Cost: Benefit Ratio of 0, 1, and 2 Medial Branch Blocks for Lumbar Facet Joint Radiofrequency Denervation

This study has been completed.

Study NCT00484159 Information provided by Johns Hopkins University

First Received on June 6, 2007. Last Updated on July 25, 2011 History of Changes

Results First Received: June 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Low Back Pain
Interventions:	Procedure: Radiofrequency denervation of medial branches Drug: 0.5% bupivacaine Drug: 2% lidocaine Procedure: Radiofrequency denervation

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
151 patients with axial low back pain and suspected lumbar facet arthropathy were recruited from pain clinics at Johns Hopkins and Walter Reed between January 2007 and April 2009 for lumbar facet interventions.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects had to be candidate for facet blocks or radiofrequency denervation. They had to have no neurological symptoms, failed conservative treatment and not had spinal fusion.

Reporting Groups

	Description
Double-block Group	Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
Single-block Group	Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
Radiofrequency Group	Radiofrequency lumbar facet denervation without a diagnostic facet block.

Participant Flow: Overall Study

	Double-block Group	Single-block Group	Radiofrequency Group
STARTED	50	50	51
COMPLETED	49	49	51
NOT COMPLETED	1	1	0
Lost to Follow-up	1	1	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Double-block Group	Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
Single-block Group	Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
Radiofrequency Group	Radiofrequency lumbar facet denervation without a diagnostic facet block.

Baseline Measures

	Double-block Group	Single-block Group	Radiofrequency Group	Total
Number of Participants [units: participants]	50	50	51	151
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	44	44	45	133
>=65 years	6	6	6	18
Gender [units: participants]
Female	23	24	20	67
Male	27	26	31	84

Outcome Measures

Show All Outcome Measures

1. Primary:

Cost Per Successful Procedure [ Time Frame: 3-months ]

Show Outcome Measure 1

2. Secondary:

Successful Treatment [ Time Frame: 3-months postprocedure ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study only followed patients for 3 months, so we don't know if proceeding straight to radiofrequency is associated with the same duration of pain relief as when diagnostic facet blocks are performed.

Results Point of Contact:

Name/Title: Steven P. Cohen
Organization: Johns Hopkins
phone: 410-955-1822
e-mail: scohen40@jhmi.edu

No publications provided

Responsible Party:	Office of Research Administration, Amanda Gibson
ClinicalTrials.gov Identifier:	NCT00484159 History of Changes
Other Study ID Numbers:	NA_00007158
Study First Received:	June 6, 2007
Results First Received:	June 22, 2011
Last Updated:	July 25, 2011
Health Authority:	United States: Institutional Review Board