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

Study Overview
=================
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: Medical care that involves prescription medications and/or spinal injections (epidurals) Group exercise in supervised classes given in a community center setting 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.

Detailed Description
-----------------
BACKGROUND: Lumbar spinal stenosis (LSS) is a condition that is highly prevalent in the senior citizen population. LSS is the most frequent indication for spinal surgery in patients over the age of 65 years. The fastest growth in lumbar surgery in the U.S. this past decade has occurred in older adults with LSS and the rate of complex fusion procedures has increased 15-fold. These surgical procedures are associated with significant health care costs, risks, complications, and re-hospitalization rates. Yet, evidence is lacking for the effectiveness of the various non-surgical treatments offered to patients with LSS. This knowledge gap has greatly hindered the development of clinical practice guidelines relevant to the non-surgical treatment approaches for LSS. OBJECTIVES: This study will perform a comparison of three common approaches to the non-surgical management and treatment of patients with LSS. The specific research questions associated with this study are: (1) How do group exercise and manual therapy with rehabilitative exercise compare with medical care? (2) How do group exercise and manual therapy with rehabilitative exercise compare with each other? (3) Are there any baseline predictors associated with clinical improvement in any of these non-surgical treatment approaches? The long term objective of this study is to produce research evidence relevant to community stakeholders and to inform better decision making about non-surgical treatment options available to LSS patients. METHODS: This will be a comparative effectiveness study utilizing the research design of a randomized controlled clinical trial (RCT). It will be a 3-group RCT that allows for pragmatic treatment approaches in each of the three study arms. The study sample will consist of 259 older adults (>60 years) who have symptoms consistent with a diagnosis of LSS, which will be confirmed by clinical examination and diagnostic imaging. Eligible subjects will be randomized into one of three pragmatic treatment approaches: 1) medical care; 2) group exercise; or 3) manual therapy with rehabilitative exercise. All subjects will be treated for a 6-week course of care. Primary outcome measures are two validated research measurement tools; the Swiss Spinal Stenosis Questionnaire (self-reported pain/function) and the Self Paced Walking Test (performance-based measure). We will also employ a novel secondary outcome measure; the Sense Wear Armband which provides a real-time measure of physical activity during normal daily living.

Official Title
-----------------
A Comparison of Non-Surgical Treatment Methods for Patients With Lumbar Spinal Stenosis

Conditions
-----------------
Lumbar Spinal Stenosis

Intervention / Treatment
-----------------
* Drug: NSAIDs; adjunctive analgesics; adjunctive anti-depressants
* Procedure: Lumbar epidural injection
* Other: Joint Mobilizations (spine, sacroiliac, hip)
* Other: Individualized exercises: clinical setting
* Other: Group Exercise: community setting


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medical Care<br>Non-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. | Drug: NSAIDs; adjunctive analgesics; adjunctive anti-depressants<br>* Physician will administer these medications based upon the individual needs of each patient.<br>* Other names: mirtazapine;Procedure: Lumbar epidural injection<br>* 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.<br>|
| Active Comparator: Group Exercise<br>Group 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. | Other: Group Exercise: community setting<br>* 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.<br>|
| Active Comparator: Manual therapy and exercise<br>This 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. | Other: Joint Mobilizations (spine, sacroiliac, hip)<br>* These joint mobilizations will be applied manually to the lumbar facet joints, sacroiliac joints, and/or hip joints by licensed physical therapists and chiropractors.<br>Other: Individualized exercises: clinical setting<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Paced Walking Test (SPWT) | Our primary aim also included a performance-based outcome measure, which was the distance walked during the SPWT. The analysis was a comparison of between-group changes in SPWT between baseline and 8 weeks. The Self-Paced Walking Test (SPWT) is a validated objective measure of a patient's walking capacity, which is performed on a level walking surface. The patient is instructed to walk at their own pace and to stop when the symptoms are troublesome enough that s/he needs to sit down to rest. The total time and total distance walked are measured by the research assistant. Our unit of measure was the total distance walked, expressed in meters. | Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Stenosis, Spinal manipulation, Exercise, Epidural injection