Trial Outcomes & Findings for Effectiveness of Lumbar Facet Joint Nerve Blocks (NCT NCT00355914)

Results Overview

Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

Baseline, 3, 6, 12, 18, and 24 months post-treatment

Results posted on

2013-11-26

Participant Flow

The recruitment period lasted from November 2003 to July 2006.

Participant milestones

Participant milestones
Measure	Group 1 Without Steroids Lumbar Facet Joint block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)	Group II With Steroids Lumbar Facet Joint block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and Steroids (0.15 mg of non-particulate betamethasone)
Overall Study STARTED	60	60
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Lumbar Facet Joint Nerve Blocks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 Without Steroids n=60 Participants Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids	Group II With Steroids n=60 Participants Lumbar Facet Joint Nerve Blocks Local anesthetic with steroids	Total n=120 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
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	53 Participants n=7 Participants	104 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Age Continuous	47 years STANDARD_DEVIATION 15 • n=5 Participants	46 years STANDARD_DEVIATION 17 • n=7 Participants	46.7 years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	33 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	27 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	60 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3, 6, 12, 18, and 24 months post-treatment

Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.

Outcome measures

Outcome measures
Measure	Group I n=60 Participants Local anesthetic without steroids	Group II n=60 Participants Local anesthetic with steroids
Average Numeric Rating Scale Baseline	8.2 units on a scale Standard Error 0.8	7.9 units on a scale Standard Error 1.0
Average Numeric Rating Scale 3 months	3.8 units on a scale Standard Error 1.3	3.5 units on a scale Standard Error 1.1
Average Numeric Rating Scale 6 months	3.6 units on a scale Standard Error 1.5	3.3 units on a scale Standard Error 0.8
Average Numeric Rating Scale 12 months	3.7 units on a scale Standard Error 1.7	3.5 units on a scale Standard Error 1.1
Average Numeric Rating Scale 18 months	3.5 units on a scale Standard Error 1.5	3.3 units on a scale Standard Error 1.0
Average Numeric Rating Scale 24 months	3.5 units on a scale Standard Error 1.5	3.2 units on a scale Standard Error 0.9

PRIMARY outcome

Timeframe: Baseline, 3, 6, 12, 18, and 24 months post-treatment.

Population: An intent-to-treat-analysis was performed on all patients utilizing the last follow-up data. Initial data were utilized in the patients who dropped out of the study without further follow-up after the first treatment.

Oswestry Disability Index 2.0 (ODI): ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100% (may be bed bound or exaggerating their symptoms).

Outcome measures

Outcome measures
Measure	Group I n=60 Participants Local anesthetic without steroids	Group II n=60 Participants Local anesthetic with steroids
Oswestry Disability Index 3 months	12.7 units on a scale Standard Deviation 4.7	13.5 units on a scale Standard Deviation 5.6
Oswestry Disability Index 6 months	12.7 units on a scale Standard Deviation 4.7	12.2 units on a scale Standard Deviation 5.0
Oswestry Disability Index Baseline	26.6 units on a scale Standard Deviation 4.6	25.9 units on a scale Standard Deviation 5.0
Oswestry Disability Index 12 months	12.3 units on a scale Standard Deviation 4.8	12.0 units on a scale Standard Deviation 5.4
Oswestry Disability Index 18 months	12.1 units on a scale Standard Deviation 5.0	11.2 units on a scale Standard Deviation 4.9
Oswestry Disability Index 24 months	12.0 units on a scale Standard Deviation 4.9	11.0 units on a scale Standard Deviation 4.8

Adverse Events

Group 1 Without Steroids

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group II With Steroids

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

Laxmaiah Manchikanti, MD

Pain Management Center of Paducah, Paducah, KY

Phone: 2705548373

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place