Trial Outcomes & Findings for Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain (NCT NCT00370994)
NCT ID: NCT00370994
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
120 participants
Primary outcome timeframe
3, 6, 12, 18 and 24 months post treatment.
Results posted on
2020-03-10
Participant Flow
An interventional pain management practice, a specialty referral center, a private practice setting in the United States
Participant milestones
| Measure |
Caudal Epidural Injection
Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution.
|
Pecutaneous Adhesiolysis
Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
|
|---|---|---|
|
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 Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain
Baseline characteristics by cohort
| Measure |
Caudal Epidural Injection
n=60 Participants
Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
|
Pecutaneous Adhesiolysis
n=60 Participants
Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
|
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
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
52 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
52 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 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: 3, 6, 12, 18 and 24 months post treatment.Population: Sample size is calculated based on reduction of NRS. A 25% clinical difference change of 1.15.
Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable
Outcome measures
| Measure |
Control Group
n=60 Participants
caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.
|
Intervention Group
n=60 Participants
adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
|
|---|---|---|
|
Numeric Pain Rating Score
6 months
|
5.8 units on a scale
Standard Deviation 1.5
|
3.7 units on a scale
Standard Deviation 1.1
|
|
Numeric Pain Rating Score
Baseline
|
7.9 units on a scale
Standard Deviation 0.8
|
8.1 units on a scale
Standard Deviation 0.8
|
|
Numeric Pain Rating Score
3 months
|
4.9 units on a scale
Standard Deviation 1.6
|
3.4 units on a scale
Standard Deviation 0.8
|
|
Numeric Pain Rating Score
12 months
|
6.1 units on a scale
Standard Deviation 1.4
|
4.0 units on a scale
Standard Deviation 1.2
|
|
Numeric Pain Rating Score
18 months
|
6.1 units on a scale
Standard Deviation 1.4
|
3.6 units on a scale
Standard Deviation 1.2
|
|
Numeric Pain Rating Score
24 months
|
6.2 units on a scale
Standard Deviation 1.4
|
3.6 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 3, 6, 12, 18 and 24 months post treatment.Oswestry 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 |
Control Group
n=60 Participants
caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.
|
Intervention Group
n=60 Participants
adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
|
|---|---|---|
|
Functional Status
Baseline
|
28.6 units on a scale
Standard Deviation 4.1
|
31.2 units on a scale
Standard Deviation 4.1
|
|
Functional Status
3 months
|
20.2 units on a scale
Standard Deviation 6.6
|
15.2 units on a scale
Standard Deviation 4.1
|
|
Functional Status
6 months
|
22.3 units on a scale
Standard Deviation 6.1
|
15.2 units on a scale
Standard Deviation 5.2
|
|
Functional Status
12 months
|
23.3 units on a scale
Standard Deviation 5.8
|
15.8 units on a scale
Standard Deviation 5.6
|
|
Functional Status
18 months
|
23.3 units on a scale
Standard Deviation 5.7
|
14.6 units on a scale
Standard Deviation 4.6
|
|
Functional Status
24 months
|
23.2 units on a scale
Standard Deviation 6.7
|
13.9 units on a scale
Standard Deviation 5.1
|
Adverse Events
Caudal Epidural Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pecutaneous Adhesiolysis
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
Dr. Laxmaiah Manchikanti
Pain Management Center of Paducah
Phone: 270-554-8373
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place