Abstract | BACKGROUND: STUDY DESIGN: A randomized, double-blind, active controlled trial. SETTING: Private interventional pain management practice and specialty referral center in the United States. OBJECTIVE: To assess the effectiveness of lumbar interlaminar epidural injections with or without steroids in providing effective and long-lasting pain relief with improvement in functional status for the management of chronic low back and lower extremity pain related to lumbar central spinal stenosis. METHODS: OUTCOMES ASSESSMENT: Outcomes were assessed utilizing the numeric pain rating scale (NRS) and Oswestry Disability Index (ODI) at 3, 6, 12, 18, and 24 months post treatment. The primary outcome measure was significant improvement, defined as 50% improvement in pain and disability scores. RESULTS: Significant relief and functional status improvement was seen in 72% and 73% of patients in Groups I and II at the end of 2 years considering all participants; however, this was 84% and 85% in the successful group. Overall significant improvement was achieved for 65.7 ± 37.3 weeks in Group 1 and 68.9 ± 37.7 weeks in Group II at the end of 2 years when all participants were considered; whereas, this was 77 ± 27.8 weeks and 77.9 ± 30.2 weeks when they were separated into successful categories. The average number of procedures per patient was 5 to 6 in both groups. LIMITATIONS: Limitations of this trial include lack of placebo control group and treatment of patients with multiple procedures over a period of 2 years. CONCLUSION: CLINICAL TRIAL: NCT00681447.
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Authors | Laxmaiah Manchikanti, Kimberly A Cash, Carla D McManus, Kim S Damron, Vidyasagar Pampati, Frank J E Falco |
Journal | Pain physician
(Pain Physician)
2015 Jan-Feb
Vol. 18
Issue 1
Pg. 79-92
ISSN: 2150-1149 [Electronic] United States |
PMID | 25675062
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anesthetics, Local
- Glucocorticoids
- Betamethasone
- Lidocaine
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Topics |
- Adult
- Aged
- Anesthetics, Local
(therapeutic use)
- Betamethasone
(administration & dosage, therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Follow-Up Studies
- Glucocorticoids
(administration & dosage, therapeutic use)
- Humans
- Injections, Epidural
(methods)
- Leg
- Lidocaine
(therapeutic use)
- Low Back Pain
(drug therapy, etiology)
- Lumbar Vertebrae
- Male
- Middle Aged
- Pain
(drug therapy, etiology)
- Pain Management
- Spinal Stenosis
(complications, drug therapy)
- Treatment Outcome
- United States
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