Trial Outcomes & Findings for Effectiveness of Thoracic Facet Joint Nerve Blocks (NCT NCT00355706)
NCT ID: NCT00355706
Last Updated: 2020-03-10
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
100 participants
Primary outcome timeframe
2 years
Results posted on
2020-03-10
Participant Flow
Participant milestones
| Measure |
Group I - Without Steroids
Group I - Thoracic medial branch blocks with local anesthetics
|
Group II - With Steroids
Group II - Thoracic medial branch blocks with bupivacaine and steroid
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Thoracic Facet Joint Nerve Blocks
Baseline characteristics by cohort
| Measure |
Group I - With Local Anesthetics
n=50 Participants
Group I - Thoracic medial branch blocks with local anesthetics
|
Group II - With Bupivacaine and Steroid
n=50 Participants
Group II - Thoracic medial branch blocks with bupivacaine and steroid
|
Total
n=100 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
|
47 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
43.8 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsNumeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.
Outcome measures
| Measure |
Group I Without Steroids
n=50 Participants
Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine)
|
Group II With Steroid
n=50 Participants
Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Steroids (0.15 mg of non-particulate betamethasone)
|
|---|---|---|
|
Numeric Rating Scale
Baseline
|
7.9 units on a scale
Standard Deviation 0.9
|
7.8 units on a scale
Standard Deviation 1.0
|
|
Numeric Rating Scale
3 months
|
3.1 units on a scale
Standard Deviation 0.9
|
3.1 units on a scale
Standard Deviation 0.7
|
|
Numeric Rating Scale
6 months
|
3.0 units on a scale
Standard Deviation 0.9
|
3.2 units on a scale
Standard Deviation 0.8
|
|
Numeric Rating Scale
12 months
|
3.2 units on a scale
Standard Deviation 0.9
|
3.1 units on a scale
Standard Deviation 1.0
|
|
Numeric Rating Scale
18 months
|
3.0 units on a scale
Standard Deviation 1.0
|
3.1 units on a scale
Standard Deviation 1.0
|
|
Numeric Rating Scale
24 months
|
3.1 units on a scale
Standard Deviation 1.2
|
3.1 units on a scale
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: 24 monthsOswestry Disability Index (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 (these patients are either bed-bound or exaggerating their symptoms).
Outcome measures
| Measure |
Group I Without Steroids
n=50 Participants
Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine)
|
Group II With Steroid
n=50 Participants
Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Steroids (0.15 mg of non-particulate betamethasone)
|
|---|---|---|
|
Oswestry Disability Index
Baseline
|
27.1 units on a scale
Standard Deviation 6.6
|
27.5 units on a scale
Standard Deviation 5.8
|
|
Oswestry Disability Index
3 months
|
13.0 units on a scale
Standard Deviation 4.9
|
11.6 units on a scale
Standard Deviation 3.7
|
|
Oswestry Disability Index
6 months
|
13.0 units on a scale
Standard Deviation 4.2
|
11.9 units on a scale
Standard Deviation 3.8
|
|
Oswestry Disability Index
12 months
|
12.0 units on a scale
Standard Deviation 4.0
|
11.8 units on a scale
Standard Deviation 3.9
|
|
Oswestry Disability Index
18 months
|
12.0 units on a scale
Standard Deviation 4.9
|
11.7 units on a scale
Standard Deviation 3.9
|
|
Oswestry Disability Index
24 months
|
11.7 units on a scale
Standard Deviation 4.9
|
11.0 units on a scale
Standard Deviation 4.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsOpioid intake(morphine equivalence mg)
Outcome measures
| Measure |
Group I Without Steroids
n=50 Participants
Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine)
|
Group II With Steroid
n=50 Participants
Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Steroids (0.15 mg of non-particulate betamethasone)
|
|---|---|---|
|
Opioid Intake
Baseline
|
48.0 mg/day
Standard Deviation 53.75
|
47.9 mg/day
Standard Deviation 48.6
|
|
Opioid Intake
3 months
|
38.0 mg/day
Standard Deviation 44.2
|
40.3 mg/day
Standard Deviation 33.9
|
|
Opioid Intake
6 months
|
38.2 mg/day
Standard Deviation 46.1
|
39.3 mg/day
Standard Deviation 34.8
|
|
Opioid Intake
12 months
|
37.6 mg/day
Standard Deviation 38.4
|
37.8 mg/day
Standard Deviation 33.2
|
|
Opioid Intake
18 months
|
37.6 mg/day
Standard Deviation 46.4
|
38.7 mg/day
Standard Deviation 35.2
|
|
Opioid Intake
24 months
|
37.6 mg/day
Standard Deviation 46.4
|
38.7 mg/day
Standard Deviation 35.2
|
Adverse Events
Group I - With Local Anesthetics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group II - With Bupivacaine and Steroid
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
Phone: 2705548373
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place