Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)
A Comparison of Non-Surgical Treatment Methods for Patients With Lumbar Spinal Stenosis
2 other identifiers
interventional
259
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2013
CompletedFirst Posted
Study publicly available on registry
September 17, 2013
CompletedStudy Start
First participant enrolled
November 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2016
CompletedResults Posted
Study results publicly available
May 17, 2017
CompletedApril 2, 2018
March 1, 2018
2.5 years
September 8, 2013
February 9, 2017
March 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Swiss Spinal Stenosis (SSS) Questionnaire Score
Our primary aim included a primary outcome measure of self-reported pain/function, which was the change in SSS total score between baseline and 8 weeks. The Swiss Spinal Stenosis Questionnaire (SSS) is a validated 12-item condition-specific instrument for patients with lumbar spinal stenosis. It provides a patient self-report measure of pain and physical function. Higher scores represent worse symptoms and less physical function. The 12-item SSS total score range is 12-55. For our analysis, we compared the change in the 12-item Total score from baseline to 8 weeks.
Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).
Secondary Outcomes (1)
Self Paced Walking Test (SPWT)
Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed).
Other Outcomes (1)
Sense Wear Armband
Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).
Study Arms (3)
Medical Care
ACTIVE COMPARATORNon-steroidal anti-inflammatory drugs (NSAIDs); adjunctive analgesics; adjunctive anti-depressants. Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. * NSAIDs: ibuprofen, celecoxib, or diclofenac/misoprostol * Adjunctive analgesics: acetaminophen, tramadol, or gabapentin * Adjunctive antidepressant agents: nortriptyline, duloxetine, sertraline, trazodone, or mirtazapine Lumbar epidural injection: these will be prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications.
Group Exercise
ACTIVE COMPARATORGroup Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.
Manual therapy and exercise
ACTIVE COMPARATORThis group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used in the physical therapy and chiropractic professions. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments will be provided by licensed physical therapists and chiropractors using a combination of Joint Mobilizations (spine, sacroiliac, hip), muscle stretching and strengthening exercises. Individualized exercises: clinical setting. These exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor.
Interventions
Physician will administer these medications based upon the individual needs of each patient.
The attending physician may refer subjects for epidural injections at a pain clinic that is affiliated with the University of Pittsburgh Medical Center. All epidural injections will be provided by licensed physicians who are board certified in physical medicine and rehabilitation or anesthesiology.
These joint mobilizations will be applied manually to the lumbar facet joints, sacroiliac joints, and/or hip joints by licensed physical therapists and chiropractors.
The treating physical therapist or chiropractor will work with each subject to develop a set of individualized exercises in the clinic setting. The goal is to have the subjects continue these exercises at home.
The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers.
Eligibility Criteria
You may qualify if:
- Minimum age of 60 years
- Can read/write English and understand directions
- Diagnosis of lumbar spinal stenosis confirmed by CT or MRI scan
- Has limitation of standing and/or walking tolerance
- Willing to attend treatments 2 times per week for 6 weeks
- Ability to walk at least 50 feet without the need for a cane or walker
You may not qualify if:
- History of metastatic cancer
- Advised by a physician not to exercise
- History of lumbar surgery for spinal stenosis or previous lumbar fusion
- Presence of severe peripheral artery disease in legs
- Severe hypertension: Systolic \> 200 mm/hg or Diastolic \> 110 mm/hg
- Ankle brachial index \< 0.8
- Neurologic or neurodegenerative disease other than stenosis that severly impairs the ability to walk
- Presence of cauda equina symptoms (saddle paresthesia, progressive loss of bladder/bowel function, etc)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UPMC Shadyside Center for Integrative Medicine
Pittsburgh, Pennsylvania, 15232, United States
Related Publications (3)
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.
PMID: 24872875BACKGROUNDRoseen 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.
PMID: 41366694DERIVEDSchneider 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.
PMID: 30646197DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
We realize in retrospect that our original choice of the term "usual medical care" may have been confusing, because there is great variation in the medical management of patients with stenosis. We suggest that "medical care" is a better term.
Results Point of Contact
- Title
- Michael Schneider, PhD, DC - Associate Professor and Principal Investigator
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Schneider, PhD, DC
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor, Department of Physical Therapy
Study Record Dates
First Submitted
September 8, 2013
First Posted
September 17, 2013
Study Start
November 20, 2013
Primary Completion
June 7, 2016
Study Completion
June 10, 2016
Last Updated
April 2, 2018
Results First Posted
May 17, 2017
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
De-identified data may be shared with other researchers at the discretion and approval of the PI.