Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain

• Sponsor: Pain Management Center of Paducah (Other)
• Overall Status: Completed
• CT.gov ID: NCT00370994
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 87
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

Clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic neurolysis compared to those patients randomized to the control group who did not receive adhesiolysis and hypertonic saline neurolysis. Improvement will be assessed in relation to the clinical outcome measures of pain and function.

Improvements among patients with adhesiolysis and hypertonic saline neurolysis and compare to control group.

Compare adverse event profile in both groups

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Procedure: Caudal epidural injection; Procedure: Percutaneous adhesiolysis	N/A

Detailed Description

Patients with chronic low back pain and lower extremity pain secondary to spinal stenosis or post lumbar laminectomy syndrome, non responsive to conservative therapy with physical therapy or chiropractic and medical therapy and fluoroscopically directed epidural steroid injections.

Single-center, prospective, controlled, double blind, randomized study. If non-responsive or at patient's request, the patient may be unblinded anytime after 3 months, and will be offered adhesiolysis and hypertonic saline neurolysis if the patient was in the control group. All patients will be unblinded at 24 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: A Randomized, Prospective, Double-blind Controlled Evaluation of the Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Procedure: Caudal epidural injection; Caudal epidural injection with catheterization
Active Comparator: Percutaneous 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	Procedure: Percutaneous adhesiolysis; Percutaneous adhesiolysis with hypertonic saline neurolysis

Outcome Measures

Primary Outcome Measures

1. Numeric Pain Rating Score [3, 6, 12, 18 and 24 months post treatment.]

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

Secondary Outcome Measures

1. Functional Status [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Over 18 years of age

• History of chronic, function limiting low back pain of at least 6 months in duration

• Able to give voluntary, written informed consent

• Able to understand investigational procedures and willing to return for follow-ups

• No recent surgical procedures within last 3 months

Exclusion Criteria:

• Large contained or sequestered herniation

• Cauda Equina symptoms and/or compressive radiculopathy

• Narcotic use of no greater than 100mg/day Hydrocodone, 60mg Methadone, or 100mg Morphine

• Uncontrolled major depression or psychiatric disorder

• Uncontrolled or acute medical illness

• Chronic sever conditions that could interfere with outcome assessments

• Women who are pregnant or lactating

• Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ambulatory Surgery Center	Paducah	Kentucky	United States	42003

Sponsors and Collaborators

• Pain Management Center of Paducah

Investigators

• Principal Investigator: Laxmaiah Manchikanti, MD, Ambulatory Surgery Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial.

Publications

None provided.

• Responsible Party: Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah
• ClinicalTrials.gov Identifier: NCT00370994
• Other Study ID Numbers: protocol 11
• First Posted: Sep 1, 2006
• Last Update Posted: Mar 10, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah: post-lumbar surgery syndrome; percutaneous lumbar epidural adhesiolysis; hypertonic saline neurolysis
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

Participant Flow

Recruitment Details	An interventional pain management practice, a specialty referral center, a private practice setting in the United States

Arm/Group Title	Caudal Epidural Injection	Pecutaneous Adhesiolysis
Arm/Group Description	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 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
Period Title: Overall Study
STARTED	60	60
COMPLETED	60	60
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Caudal Epidural Injection	Pecutaneous Adhesiolysis	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	60	60	120
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	44 73.3%	48 80%	92 76.7%
>=65 years	16 26.7%	12 20%	28 23.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52 (13.9)	52 (12.5)	52 (13.2)
Sex: Female, Male (Count of Participants)
Female	35 58.3%	35 58.3%	70 58.3%
Male	25 41.7%	25 41.7%	50 41.7%
Region of Enrollment (participants) [Number]
United States	60 100%	60 100%	120 100%

Outcome Measures

1. Primary Outcome

Title	Numeric Pain Rating Score
Description	Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable
Time Frame	3, 6, 12, 18 and 24 months post treatment.

Outcome Measure Data

Analysis Population Description

Sample size is calculated based on reduction of NRS. A 25% clinical difference change of 1.15.

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.	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
Measure Participants	60	60
Baseline	7.9 (0.8)	8.1 (0.8)
3 months	4.9 (1.6)	3.4 (0.8)
6 months	5.8 (1.5)	3.7 (1.1)
12 months	6.1 (1.4)	4.0 (1.2)
18 months	6.1 (1.4)	3.6 (1.2)
24 months	6.2 (1.4)	3.6 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Intervention Group
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Comparisons were made between groups and within the group between baseline and different time points.
	Method	Repeated measures ANOVA.
	Comments

2. Secondary Outcome

Title	Functional Status
Description	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.
Time Frame	3, 6, 12, 18 and 24 months post treatment.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.	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
Measure Participants	60	60
Baseline	28.6 (4.1)	31.2 (4.1)
3 months	20.2 (6.6)	15.2 (4.1)
6 months	22.3 (6.1)	15.2 (5.2)
12 months	23.3 (5.8)	15.8 (5.6)
18 months	23.3 (5.7)	14.6 (4.6)
24 months	23.2 (6.7)	13.9 (5.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Intervention Group
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	There were significant differences in Oswestry Disability Index between both groups
	Method	Repeated measures of ANOVA
	Comments

Adverse Events

Arm/Group Title	Caudal Epidural Injection		Pecutaneous Adhesiolysis
Arm/Group Description	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 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
All Cause Mortality
	Caudal Epidural Injection		Pecutaneous Adhesiolysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Caudal Epidural Injection		Pecutaneous Adhesiolysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Caudal Epidural Injection		Pecutaneous Adhesiolysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)

Limitations/Caveats

The results of this study are limited by potentially inadequate double blinding, by the lack of a placebo group.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.