Trial Outcomes & Findings for Efficacy and Cost: Benefit Ratio of 0, 1, and 2 Medial Branch Blocks for Lumbar Facet Joint Radiofrequency Denervation (NCT NCT00484159)

Results Overview

Total cost per effective treatment at 3-months. Successful procedure defined as greater or equal to 50% pain relief and satisfaction lasting at least 3 months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

151 participants

Primary outcome timeframe

3-months

Results posted on

2011-07-26

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	50	50	51
Overall Study COMPLETED	49	49	51
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	1	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double-block Group n=50 Participants Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.	Single-block Group n=50 Participants Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.	Radiofrequency Group n=51 Participants Radiofrequency lumbar facet denervation without a diagnostic facet block.	Total n=151 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	44 Participants n=7 Participants	45 Participants n=5 Participants	133 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	20 Participants n=5 Participants	67 Participants n=4 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	26 Participants n=7 Participants	31 Participants n=5 Participants	84 Participants n=4 Participants

PRIMARY outcome

Timeframe: 3-months

Total cost per effective treatment at 3-months. Successful procedure defined as greater or equal to 50% pain relief and satisfaction lasting at least 3 months.

Outcome measures

Outcome measures
Measure	Double-block Group n=50 Participants Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.	Single-block Group n=50 Participants Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.	Radiofrequency Group n=51 Participants Radiofrequency lumbar facet denervation without a diagnostic facet block.
Cost Per Successful Procedure	15,241 U.S. dollars	17,142 U.S. dollars	6286 U.S. dollars

SECONDARY outcome

Timeframe: 3-months postprocedure

Greater or equal to 50% pain relief plus procedural satisfaction lasting at least 3 months. What is being measured is the number of participants with a positive outcome.

Outcome measures

Outcome measures
Measure	Double-block Group n=50 Participants Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.	Single-block Group n=50 Participants Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.	Radiofrequency Group n=51 Participants Radiofrequency lumbar facet denervation without a diagnostic facet block.
Successful Treatment	9 participants	7 participants	17 participants

Adverse Events

Double-block Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single-block Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Radiofrequency Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven P. Cohen

Johns Hopkins

Phone: 410-955-1822

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place