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A comparison of non-surgical treatment methods for patients with lumbar spinal stenosis
Investigator (PI): Schneider, Michael J
Performing Organization (PO): (Current): University of Pittsburgh, School of Health and Rehabilitation Sciences, Department of Physical Therapy / (412) 383-6630
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2013
Final Year: 2018
Record Source/Award ID: PCORI/587
Funding: Total Award Amount: $1,826,997
Award Type: Grant
Award Information: PCORI: More information and project results (when completed)
Abstract: 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 older than 65 to have back surgery. These operations are expensive and risky, with a high number of complications that cause many patients to be re-admitted to the hospital. A large number of 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 do not 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. usual medical care that involves prescription drugs and/or injections (epidural) into the spine, 2. group exercise in supervised classes given in a community center setting, and 3. hands-on (manual) therapy and rehabilitative exercises given in a clinic setting by physical therapists and chiropractors. The researchers are interested in answering several questions that are important to patients: How do group exercise and manual therapy with rehabilitative exercise compare with usual medical care? How does community-based group exercise compare with clinic-based manual therapy and rehabilitative exercise? Are group exercise classes an effective and safe alternative for older adults with stenosis? Are there any key findings from what the doctor finds on examination that would be helpful in determining which type of treatment would be best for individual patients? Methods: This research study will involve 150 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 three 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 three 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.
MeSH Terms:
  • Aged
  • Chiropractic
  • Community Health Services /organization & administration
  • Comparative Effectiveness Research
  • Drug Therapy /methods
  • Exercise Therapy /methods
  • Humans
  • Injections, Epidural
  • Lumbar Vertebrae /*pathology
  • Middle Aged
  • Outcome Assessment, Health Care
  • Physical Therapy Modalities
  • Randomized Controlled Trials as Topic
  • Rehabilitation /methods
  • Risk
  • Spinal Stenosis /*therapy
  • Treatment Outcome
Country: United States
State: Pennsylvania
Zip Code: 15260
UI: 20142228
CTgovId: NCT01943435
Project Status: Completed
Record History: ('2018: Project extended to 2018. 2017: Project extended to 2017.',)