Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)

• Status: Completed
• Trial end date: 2016-06-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Schneider, DC, PhD; University of Pittsburgh
• Collaborator: Patient-Centered Outcomes Research Institute
• Treatments: Acetaminophen; Analgesics; Antidepressive Agents; Celecoxib; Diclofenac; Duloxetine Hydrochloride; Gabapentin; Ibuprofen; Mirtazapine; Misoprostol; Nortriptyline; Sertraline; Tramadol; Trazodone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)