Trial Outcomes & Findings for Effectiveness of Cervical Facet Joint Nerve Blocks (NCT NCT00332722)

NCT ID: NCT00332722

Last Updated: 2013-10-01

Results Overview

Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: over 2 years
• Results posted on: 2013-10-01

Participant Flow

Consecutive new patients presenting to interventional pain management practice with neck pain without suspected disc herniation or radiculitis.

Participant milestones

Measure	Group 1 Without Steroids Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)	Group 2 With Steroids Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 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 Cervical Facet Joint Nerve Blocks

Baseline characteristics by cohort

Measure	Group 1- Without Steroid n=60 Participants Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)	Group 2 - With Steroid n=60 Participants Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)	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	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	46 years STANDARD_DEVIATION 13.2 • n=5 Participants	43 years STANDARD_DEVIATION 14.1 • n=7 Participants	44 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	48 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	12 Participants n=7 Participants	31 Participants n=5 Participants
duration of pain	120 months STANDARD_DEVIATION 122 • n=5 Participants	87 months STANDARD_DEVIATION 104 • n=7 Participants	103 months STANDARD_DEVIATION 174 • n=5 Participants

PRIMARY outcome

Timeframe: over 2 years

Population: A sample size of 60 patients for each group was chosen.

Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable.

Outcome measures

Measure	Group 1 - Without Steroids n=60 Participants Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)	Group 2 - With Steroids n=60 Participants Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
Numeric Rating Scale (NRS) Baseline	8.2 units on a scale Standard Deviation 0.8	8.2 units on a scale Standard Deviation 1.1
Numeric Rating Scale (NRS) 2 years	3.5 units on a scale Standard Deviation 1.1	3.2 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 2 years

Neck Disability Index (range 0-50) is represented as 0-4 no disability, 5-14 mild disability, 15 - 24 moderate disability, 25 - 34 severe disability and >34 (35-50) complete disability.

Outcome measures

Measure	Group 1 - Without Steroids n=60 Participants Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)	Group 2 - With Steroids n=60 Participants Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
Neck Disability Index (NDI) Baseline	25.4 units on a scale Standard Deviation 5.7	25.1 units on a scale Standard Deviation 5.0
Neck Disability Index (NDI) 24 months	11.6 units on a scale Standard Deviation 5.2	11.0 units on a scale Standard Deviation 4.7

Adverse Events

Group 1- Without Steroid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 - With Steroid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1- Without Steroid n=60 participants at risk Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)	Group 2 - With Steroid n=60 participants at risk Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
Infections and infestations Infection	0.00% 0/60 • 24 months Infection, Nerve root or Spinal cord trauma	0.00% 0/60 • 24 months Infection, Nerve root or Spinal cord trauma

Other adverse events

Adverse event data not reported

Additional Information

Dr. Laxmaiah Manchikanti, MD

Pain Management Center of Paducah

Phone: 2705548373

Email: drlm@thepainmd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place