Recruitment

Recruitment Status
Completed
Estimated Enrollment
180

Inclusion Criterias

Willing to attend treatments 2 times per week for 6 weeks
Has limitation of standing and/or walking tolerance
Diagnosis of lumbar spinal stenosis confirmed by CT or MRI scan
...
Willing to attend treatments 2 times per week for 6 weeks
Has limitation of standing and/or walking tolerance
Diagnosis of lumbar spinal stenosis confirmed by CT or MRI scan
Can read/write English and understand directions
Minimum age of 60 years
Ability to walk at least 50 feet without the need for a cane or walker

Exclusion Criterias

Presence of severe peripheral artery disease in legs
Severe hypertension: Systolic > 200 mm/hg or Diastolic > 110 mm/hg
History of metastatic cancer
...
Presence of severe peripheral artery disease in legs
Severe hypertension: Systolic > 200 mm/hg or Diastolic > 110 mm/hg
History of metastatic cancer
History of lumbar surgery for spinal stenosis or previous lumbar fusion
Presence of cauda equina symptoms (saddle paresthesia, progressive loss of bladder/bowel function, etc)
Advised by a physician not to exercise
Ankle brachial index < 0.8
Neurologic or neurodegenerative disease other than stenosis that severly impairs the ability to walk

Summary

Conditions
Lumbar Spinal Stenosis
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 60 years and 125 years
Gender
Both males and females

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 adul...

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.

Inclusion Criterias

Willing to attend treatments 2 times per week for 6 weeks
Has limitation of standing and/or walking tolerance
Diagnosis of lumbar spinal stenosis confirmed by CT or MRI scan
...
Willing to attend treatments 2 times per week for 6 weeks
Has limitation of standing and/or walking tolerance
Diagnosis of lumbar spinal stenosis confirmed by CT or MRI scan
Can read/write English and understand directions
Minimum age of 60 years
Ability to walk at least 50 feet without the need for a cane or walker

Exclusion Criterias

Presence of severe peripheral artery disease in legs
Severe hypertension: Systolic > 200 mm/hg or Diastolic > 110 mm/hg
History of metastatic cancer
...
Presence of severe peripheral artery disease in legs
Severe hypertension: Systolic > 200 mm/hg or Diastolic > 110 mm/hg
History of metastatic cancer
History of lumbar surgery for spinal stenosis or previous lumbar fusion
Presence of cauda equina symptoms (saddle paresthesia, progressive loss of bladder/bowel function, etc)
Advised by a physician not to exercise
Ankle brachial index < 0.8
Neurologic or neurodegenerative disease other than stenosis that severly impairs the ability to walk

Locations

Pittsburgh, Pennsylvania, 15232
Pittsburgh, Pennsylvania, 15232

Tracking Information

NCT #
NCT01943435
Collaborators
Patient-Centered Outcomes Research Institute
Investigators
  • Principal Investigator: Michael J Schneider, PhD, DC University of Pittsburgh
  • Michael J Schneider, PhD, DC University of Pittsburgh