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

Lumbar Spinal Stenosis research study

What is the primary objective of this study?

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. Usual 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 180 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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Lumbar Spinal Stenosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:NSAIDs; adjunctive analgesics; adjunctive anti-depressantsPhysician will administer these medications based upon the individual needs of each patient.

Procedure:Lumbar epidural injectionThe 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 settingThe 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 settingThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Usual Medical CareNon-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 ExerciseGroup 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 exerciseThis 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, 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.

Study Status

Completed

Start Date: October 2013

Completed Date: July 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Swiss Spinal Stenosis (SSS) Questionnaire Score (Symptom Severity Subscore)

Secondary Outcome: Self Paced Walking Test (SPWT)

Study sponsors, principal investigator, and references

Principal Investigator: Michael J Schneider, PhD, DC

Lead Sponsor: University of Pittsburgh

Collaborator: Patient-Centered Outcomes Research Institute

More information:https://clinicaltrials.gov/show/NCT01943435

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.

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