Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)
Summary
BACKGROUND: Lumbar spinal stenosis - known by patients as "arthritis of the spine" - is a condition that is very common; found in about 30% of older adults. It is the most common reason for people over the age of 65 to have back surgery. Some patients with stenosis do not need back surgery and can be treated with other methods, such as physical therapy, chiropractic, exercise, and medication. But we just don't have enough good research to tell us which treatment works best for which patient and under which circumstances. This research study hopes to provide more information about the effectiveness of the various non-surgical choices for managing stenosis. OBJECTIVES: This study will directly compare the effectiveness of three common non-surgical treatment approaches for stenosis: 1. Medical care that involves prescription medications and/or spinal injections (epidurals) 2. Group exercise in supervised classes given in a community center setting 3. Hands-on (manual) therapy and rehabilitative exercises given in a clinic setting by physical therapists and chiropractors METHODS: This research study will involve 259 adults who are at least 60 years old and have been diagnosed with lumbar spinal stenosis. The research volunteers will be divided into three groups, each group receiving one of the 3 types of treatments listed above under "Objectives". The determination of which type of treatment each person receives will be determined by chance, using a computerized version of flipping a coin. This is a process known as randomization, which scientists think reduces the bias in research studies. A series of tests and questionnaires will be given to the patients before and after they get treatment and comparisons will be made to see how much improvement they made with each of the types of treatments. Finally, the researchers will compare the differences between the 3 treatment groups to see if certain types of treatment produced better results than others, and if there were any examination findings that could be used to predict which type of patient would do better with which type of treatment.
Timeline
- Start
- 2013-11-20
- Primary completion
- 2016-06-07
- Completion
- 2016-06-10
Publications
- Background Schneider M, Ammendolia C, Murphy D, Glick R, Piva S, Hile E, Tudorascu D, Morton SC. Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized controlled trial. Chiropr Man Therap. 2014 May 10;22:19. doi: 10.1186/2045-709X-22-19. eCollection 2014.
- Roseen EJ, Smith CN, Rahim A, Deal C, Fischer R, Morone NE, Flack A, Penza C, Suri P, Dougherty PE, Weiner DK, Schneider MJ. Which lumbar spinal stenosis patients will improve with nonsurgical treatment? A secondary analysis of a randomized controlled trial. Chiropr Man Therap. 2025 Dec 9;33(1):57. doi: 10.1186/s12998-025-00620-0.
- Schneider MJ, Ammendolia C, Murphy DR, Glick RM, Hile E, Tudorascu DL, Morton SC, Smith C, Patterson CG, Piva SR. Comparative Clinical Effectiveness of Nonsurgical Treatment Methods in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186828. doi: 10.1001/jamanetworkopen.2018.6828.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | — | — |
| Comparator | Celecoxib | Other / unclassified | — | — |
| Comparator | Diclofenac | Other / unclassified | — | — |
| Comparator | Duloxetine | Small molecule | — | — |
| Comparator | Gabapentin | Small molecule | — | — |
| Comparator | Ibuprofen | Small molecule | — | — |
| Comparator | Mirtazapine | Other / unclassified | — | — |
| Comparator | Misoprostol | Other / unclassified | — | — |
| Comparator | Nortriptyline | Small molecule | — | — |
| Comparator | Sertraline | Small molecule | — | — |
| Comparator | Tramadol | Other / unclassified | — | — |
| Comparator | Trazodone | Small molecule | — | — |