Low Back Pain
Conditions
Keywords
Lumbar Facet Joint Nerve Block
Brief summary
1. To demonstrate whether: i. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect. ii. Adjuvant medications (Sarapin and Depo-steroids) provide additional relief of lumbar facet joint pain when used with facet joint nerve blocks. 2. To demonstrate whether or not there are clinically significant improvements in function of patients who receive lumbar facet joint nerve block with or without Sarapin and Depo-steroids (Group II) compared to patients randomized to Group I who receive only local anesthetic blocks. 3. To determine the adverse event profile in both groups.
Detailed description
Primary Outcome Measure(s) To demonstrate a clinically significant difference between the patients treated with adjuvants and those patients randomized to Group I in the pain status, physical, and psychological status and pain at 3, 6, 12, 18and 24 months post treatment.
Interventions
PROCEDURELumbar Facet Joint Nerve Block
Lumbar Facet Joint Nerve Block
Sponsors
Pain Management Center of Paducah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Positive for facet joint pain with comparative local anesthetic blocks Candidates are over 18 years of age Subjects with a history of chronic, function limiting low back pain of at least six months in duration Subjects who are able to give voluntary, written informed consent to participate in this investigation Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the center for all the required post-operative follow-ups The subject has not had recent surgical procedures within the last three months.
Exclusion criteria
* Negative or false-positive response to controlled comparative local anesthetic blocks Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 mg, or dose equivalent Uncontrolled major Depression or uncontrolled psychiatric disorders Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intercranial pressure, pseudotumor cerebri, intercranial tumors, unstable angina, and severe chronic obstructive pulmonary disease. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function Women who are pregnant or lactating Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment Patients with multiple complaints involving concomitant hip osteoarthritis, will not be amenable to study due to the overlap of pain complaints. Inability to achieve appropriate positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Numeric Rating Scale | Baseline, 3, 6, 12, 18, and 24 months post-treatment | Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable. |
| Oswestry Disability Index | Baseline, 3, 6, 12, 18, and 24 months post-treatment. | Oswestry Disability Index 2.0 (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% (may be bed bound or exaggerating their symptoms). |
Countries
United States
Participant flow
Recruitment details
The recruitment period lasted from November 2003 to July 2006.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Without Steroids Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids | 60 |
| Group II With Steroids Lumbar Facet Joint Nerve Blocks Local anesthetic with steroids | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Group II With Steroids | Group 1 Without Steroids | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 9 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 51 Participants | 104 Participants |
| Age Continuous | 46 years STANDARD_DEVIATION 17 | 47 years STANDARD_DEVIATION 15 | 46.7 years STANDARD_DEVIATION 15.3 |
| Region of Enrollment United States | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 33 Participants | 39 Participants | 72 Participants |
| Sex: Female, Male Male | 27 Participants | 21 Participants | 48 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
Average Numeric Rating Scale
Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.
Time frame: Baseline, 3, 6, 12, 18, and 24 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I | Average Numeric Rating Scale | Baseline | 8.2 units on a scale | Standard Error 0.8 |
| Group I | Average Numeric Rating Scale | 3 months | 3.8 units on a scale | Standard Error 1.3 |
| Group I | Average Numeric Rating Scale | 6 months | 3.6 units on a scale | Standard Error 1.5 |
| Group I | Average Numeric Rating Scale | 12 months | 3.7 units on a scale | Standard Error 1.7 |
| Group I | Average Numeric Rating Scale | 18 months | 3.5 units on a scale | Standard Error 1.5 |
| Group I | Average Numeric Rating Scale | 24 months | 3.5 units on a scale | Standard Error 1.5 |
| Group II | Average Numeric Rating Scale | 18 months | 3.3 units on a scale | Standard Error 1 |
| Group II | Average Numeric Rating Scale | Baseline | 7.9 units on a scale | Standard Error 1 |
| Group II | Average Numeric Rating Scale | 12 months | 3.5 units on a scale | Standard Error 1.1 |
| Group II | Average Numeric Rating Scale | 3 months | 3.5 units on a scale | Standard Error 1.1 |
| Group II | Average Numeric Rating Scale | 24 months | 3.2 units on a scale | Standard Error 0.9 |
| Group II | Average Numeric Rating Scale | 6 months | 3.3 units on a scale | Standard Error 0.8 |
Comparison: compared baseline, 3, 6, 12, 18, and 24 months between groupsp-value: >0.05t-test, 2 sided
Primary
Oswestry Disability Index
Oswestry Disability Index 2.0 (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% (may be bed bound or exaggerating their symptoms).
Time frame: Baseline, 3, 6, 12, 18, and 24 months post-treatment.
Population: An intent-to-treat-analysis was performed on all patients utilizing the last follow-up data. Initial data were utilized in the patients who dropped out of the study without further follow-up after the first treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I | Oswestry Disability Index | 3 months | 12.7 units on a scale | Standard Deviation 4.7 |
| Group I | Oswestry Disability Index | 12 months | 12.3 units on a scale | Standard Deviation 4.8 |
| Group I | Oswestry Disability Index | Baseline | 26.6 units on a scale | Standard Deviation 4.6 |
| Group I | Oswestry Disability Index | 18 months | 12.1 units on a scale | Standard Deviation 5 |
| Group I | Oswestry Disability Index | 6 months | 12.7 units on a scale | Standard Deviation 4.7 |
| Group I | Oswestry Disability Index | 24 months | 12.0 units on a scale | Standard Deviation 4.9 |
| Group II | Oswestry Disability Index | 24 months | 11.0 units on a scale | Standard Deviation 4.8 |
| Group II | Oswestry Disability Index | Baseline | 25.9 units on a scale | Standard Deviation 5 |
| Group II | Oswestry Disability Index | 3 months | 13.5 units on a scale | Standard Deviation 5.6 |
| Group II | Oswestry Disability Index | 6 months | 12.2 units on a scale | Standard Deviation 5 |
| Group II | Oswestry Disability Index | 12 months | 12.0 units on a scale | Standard Deviation 5.4 |
| Group II | Oswestry Disability Index | 18 months | 11.2 units on a scale | Standard Deviation 4.9 |
Comparison: baseline, 3, 6, 12, 18, and 24 months between groupsp-value: >0.05t-test, 2 sided