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Trial record 1 of 1 for:    NCT01943435
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Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)

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ClinicalTrials.gov Identifier: NCT01943435
Recruitment Status : Completed
First Posted : September 17, 2013
Results First Posted : May 17, 2017
Last Update Posted : April 2, 2018
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Michael Schneider, DC, PhD, University of Pittsburgh

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:

  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.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Non-Surgical Treatment Methods for Patients With Lumbar Spinal Stenosis
Actual Study Start Date : November 20, 2013
Actual Primary Completion Date : June 7, 2016
Actual Study Completion Date : June 10, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Active Comparator: Medical Care

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
Physician will administer these medications based upon the individual needs of each patient.
Other Names:
  • ibuprofen
  • celecoxib
  • diclofenac
  • misoprostol
  • acetaminophen
  • tramadol
  • gabapentin
  • nortriptyline
  • duloxetine
  • sertraline
  • trazodone
  • mirtazapine

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.

Active Comparator: Group Exercise
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
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.

Active Comparator: Manual therapy and exercise

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)
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.

Primary Outcome Measures :
  1. Swiss Spinal Stenosis (SSS) Questionnaire Score [ Time Frame: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention). ]
    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.

Secondary Outcome Measures :
  1. Self Paced Walking Test (SPWT) [ Time Frame: Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed). ]
    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.

Other Outcome Measures:
  1. Sense Wear Armband [ Time Frame: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention). ]
    Our secondary aim was to measure the change in physical activity between baseline and 8 weeks using the Sense Wear armband (SWA). The outcome measure was the average number of minutes spent daily performing physical activities >1.5 metabolic equivalents (METs).The SWA is a small device that collects information from multiple sensors: a triaxial accelerometer, heat flux, skin temperature, and galvanic signal. The information is integrated and processed by software using proprietary algorithms utilizing subjects' demographic characteristics (gender, age, height, and weight) to provide minute-by-minute estimates of physical activity. The SWA has shown good reliability and validity. The research participants in our study will wear the SWA for a week before and after they complete the treatment interventions.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943435

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United States, Pennsylvania
UPMC Shadyside Center for Integrative Medicine
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Michael Schneider, DC, PhD
Patient-Centered Outcomes Research Institute
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Principal Investigator: Michael J Schneider, PhD, DC University of Pittsburgh
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Schneider, DC, PhD, Assistant Professor, Department of Physical Therapy, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01943435    
Other Study ID Numbers: PRO12120422
587 ( Other Grant/Funding Number: PCORI )
First Posted: September 17, 2013    Key Record Dates
Results First Posted: May 17, 2017
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data may be shared with other researchers at the discretion and approval of the PI.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Keywords provided by Michael Schneider, DC, PhD, University of Pittsburgh:
Spinal Stenosis
Spinal manipulation
Epidural injection
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Duloxetine Hydrochloride
Antidepressive Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors