Abstract | BACKGROUND: STUDY DESIGN: A randomized, equivalence, controlled trial. SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVES: To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain with lumbar central spinal stenosis and compare with fluoroscopically directed caudal epidural injections. METHODS: Patients were randomly assigned to one of 2 groups with 25 patients in each group. Group I patients received caudal epidural injections with catheterization up to S3 with local anesthetic, 0.9% sodium chloride solution, non-particulate betamethasone and served as the control group. Group II patients received percutaneous adhesiolysis with targeted delivery and injection of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate Betamethasone and formed the intervention group. Randomization was performed by computer-generated random allocation sequence by simple randomization. OUTCOMES ASSESSMENT: Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12 months post treatment. Significant pain relief was described as 50% or more, whereas significant improvement in the disability score was defined as a reduction of 40% or more. RESULTS: This evaluation showed significant pain relief (>or= 50%) in 76% of the patients at one year follow-up in the adhesiolysis group compared to 4% of the patients in the control group. LIMITATIONS: The results of this study are limited by the lack of a placebo group, the fact that it is a preliminary report, and there are only 25 patients in each group. CONCLUSIONS:
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Authors | Laxmaiah Manchikanti, Kimberly A Cash, Carla D McManus, Vidyasagar Pampati, Vijay Singh, Ramsin Benyamin |
Journal | Pain physician
(Pain Physician)
2009 Nov-Dec
Vol. 12
Issue 6
Pg. E341-54
ISSN: 2150-1149 [Electronic] United States |
PMID | 19935991
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anesthetics, Local
- Steroids
- Lidocaine
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Topics |
- Aged
- Anesthesia, Epidural
(methods)
- Anesthetics, Local
(administration & dosage)
- Case-Control Studies
- Chi-Square Distribution
- Chronic Disease
- Disability Evaluation
- Double-Blind Method
- Female
- Humans
- Injections, Epidural
(methods)
- Lidocaine
(administration & dosage)
- Low Back Pain
(drug therapy, etiology, surgery)
- Male
- Middle Aged
- Pain Measurement
(methods)
- Spinal Stenosis
(complications)
- Steroids
(administration & dosage)
- Time Factors
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