Low Back Pain
Conditions
Keywords
post-lumbar surgery syndrome, percutaneous lumbar epidural adhesiolysis, hypertonic saline neurolysis
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
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.
Interventions
PROCEDURECaudal epidural injection
Caudal epidural injection with catheterization
PROCEDUREPercutaneous adhesiolysis
Percutaneous adhesiolysis with hypertonic saline neurolysis
Sponsors
Pain Management Center of Paducah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
An interventional pain management practice, a specialty referral center, a private practice setting in the United States
Participants by arm
| Arm | Count |
|---|---|
| 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 | 60 |
| 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 | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Pecutaneous Adhesiolysis | Caudal Epidural Injection | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 16 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 44 Participants | 92 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 12.5 | 52 years STANDARD_DEVIATION 13.9 | 52 years STANDARD_DEVIATION 13.2 |
| Region of Enrollment United States | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Male | 25 Participants | 25 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Numeric Pain Rating Score
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.
Population: Sample size is calculated based on reduction of NRS. A 25% clinical difference change of 1.15.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Numeric Pain Rating Score | 6 months | 5.8 units on a scale | Standard Deviation 1.5 |
| Control Group | Numeric Pain Rating Score | 18 months | 6.1 units on a scale | Standard Deviation 1.4 |
| Control Group | Numeric Pain Rating Score | 3 months | 4.9 units on a scale | Standard Deviation 1.6 |
| Control Group | Numeric Pain Rating Score | 24 months | 6.2 units on a scale | Standard Deviation 1.4 |
| Control Group | Numeric Pain Rating Score | 12 months | 6.1 units on a scale | Standard Deviation 1.4 |
| Control Group | Numeric Pain Rating Score | Baseline | 7.9 units on a scale | Standard Deviation 0.8 |
| Intervention Group | Numeric Pain Rating Score | 12 months | 4.0 units on a scale | Standard Deviation 1.2 |
| Intervention Group | Numeric Pain Rating Score | 3 months | 3.4 units on a scale | Standard Deviation 0.8 |
| Intervention Group | Numeric Pain Rating Score | 6 months | 3.7 units on a scale | Standard Deviation 1.1 |
| Intervention Group | Numeric Pain Rating Score | Baseline | 8.1 units on a scale | Standard Deviation 0.8 |
| Intervention Group | Numeric Pain Rating Score | 18 months | 3.6 units on a scale | Standard Deviation 1.2 |
| Intervention Group | Numeric Pain Rating Score | 24 months | 3.6 units on a scale | Standard Deviation 1.2 |
p-value: <0.001Repeated measures ANOVA.
Secondary
Functional Status
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Functional Status | Baseline | 28.6 units on a scale | Standard Deviation 4.1 |
| Control Group | Functional Status | 3 months | 20.2 units on a scale | Standard Deviation 6.6 |
| Control Group | Functional Status | 6 months | 22.3 units on a scale | Standard Deviation 6.1 |
| Control Group | Functional Status | 12 months | 23.3 units on a scale | Standard Deviation 5.8 |
| Control Group | Functional Status | 18 months | 23.3 units on a scale | Standard Deviation 5.7 |
| Control Group | Functional Status | 24 months | 23.2 units on a scale | Standard Deviation 6.7 |
| Intervention Group | Functional Status | 18 months | 14.6 units on a scale | Standard Deviation 4.6 |
| Intervention Group | Functional Status | Baseline | 31.2 units on a scale | Standard Deviation 4.1 |
| Intervention Group | Functional Status | 12 months | 15.8 units on a scale | Standard Deviation 5.6 |
| Intervention Group | Functional Status | 3 months | 15.2 units on a scale | Standard Deviation 4.1 |
| Intervention Group | Functional Status | 24 months | 13.9 units on a scale | Standard Deviation 5.1 |
| Intervention Group | Functional Status | 6 months | 15.2 units on a scale | Standard Deviation 5.2 |
p-value: 0.001Repeated measures of ANOVA