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.

Conditions

• Lumbar Spinal Stenosis

Interventions

DRUG

NSAIDs; adjunctive analgesics; adjunctive anti-depressants

Physician will administer these medications based upon the individual needs of each patient.

PROCEDURE

Lumbar epidural injection

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.

OTHER

Joint Mobilizations (spine, sacroiliac, hip)

These joint mobilizations will be applied manually to the lumbar facet joints, sacroiliac joints, and/or hip joints by licensed physical therapists and chiropractors.

OTHER

Individualized exercises: clinical setting

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.

OTHER

Group Exercise: community setting

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.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Michael Schneider, DC, PhD

  lead OTHER

Principal Investigators

• Michael J Schneider, PhD, DC · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-20

Primary Completion

2016-06-07

Completion

2016-06-10

Countries

• United States

Study Locations