An interventional study of Lumbar Facet Joint Nerve Block in Low Back Pain, sponsored by Pain Management Center of Paducah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-26.
Sponsored by Pain Management Center of Paducah · Not applicable, Interventional, and Treatment
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.
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.
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Pain Management Center of Paducah is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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
Lumbar Facet Joint Nerve Block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
Procedure: Lumbar Facet Joint Nerve Block
Lumbar Facet Joint Nerve Block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
Procedure: Lumbar Facet Joint Nerve Block
Lumbar Facet Joint Nerve Block
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
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.
The recruitment period lasted from November 2003 to July 2006.
| Milestone | Group 1 Without Steroids | Group II With Steroids |
|---|---|---|
| Started | 60 | 60 |
| Completed | 60 | 60 |
| Not completed | 0 | 0 |
Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.
| units on a scale | Group I | Group II |
|---|---|---|
| Baseline | 8.2 ± 0.8 | 7.9 ± 1.0 |
| 3 months | 3.8 ± 1.3 | 3.5 ± 1.1 |
| 6 months | 3.6 ± 1.5 | 3.3 ± 0.8 |
| 12 months | 3.7 ± 1.7 | 3.5 ± 1.1 |
| 18 months | 3.5 ± 1.5 | 3.3 ± 1.0 |
| 24 months | 3.5 ± 1.5 | 3.2 ± 0.9 |
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).
| units on a scale | Group 1 Without Steroids | Group II With Steroids |
|---|---|---|
| Baseline | 26.6 ± 4.6 | 25.9 ± 5.0 |
| 3 months | 12.7 ± 4.7 | 13.5 ± 5.6 |
| 6 months | 12.7 ± 4.7 | 12.2 ± 5.0 |
| 12 months | 12.3 ± 4.8 | 12.0 ± 5.4 |
| 18 months | 12.1 ± 5.0 | 11.2 ± 4.9 |
| 24 months | 12.0 ± 4.9 | 11.0 ± 4.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 Without Steroids | — | 0/60 (0%) | 0/60 (0%) |
| Group II With Steroids | — | 0/60 (0%) | 0/60 (0%) |
| Age, Categorical(Participants) | Group 1 Without Steroids | Group II With Steroids | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 51 | 53 | 104 |
| >=65 years | 9 | 7 | 16 |
| Age Continuous(years) | Group 1 Without Steroids | Group II With Steroids | Total |
|---|---|---|---|
| Mean | 47 ± 15 | 46 ± 17 | 46.7 ± 15.3 |
| Sex: Female, Male(Participants) | Group 1 Without Steroids | Group II With Steroids | Total |
|---|---|---|---|
| Female | 39 | 33 | 72 |
| Male | 21 | 27 | 48 |
| Region of Enrollment(participants) | Group 1 Without Steroids | Group II With Steroids | Total |
|---|---|---|---|
| United States | 60 | 60 | 120 |
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Pain Management Center of Paducah