NCT00022776

Brief Summary

Lumbar spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) is a condition that occurs frequently, particularly in the elderly. This condition can lead to significant pain and limit a person's ability to function. Moreover, doctors disagree about the best way to treat people with lumbar spinal stenosis. In this study we will compare surgical treatment of lumbar spinal stenosis with nonsurgical treatment using physical therapy. The results of this study should help clarify which treatment strategies are the most effective for patients with lumbar spinal stenosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2001

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 27, 2013

Status Verified

February 1, 2013

Enrollment Period

7.3 years

First QC Date

August 13, 2001

Last Update Submit

February 26, 2013

Conditions

Spinal Stenosis

Keywords

Human therapy evaluationOrthopedicsPhysical therapyNonsurgical treatmentSurgical decompressionSurgeryLumbarSpine disorderSpinal stenosisGender differenceMedical rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Medical Outcomes Study 36-item Short Form Health Survey

    Measured at Month 24

Secondary Outcomes (4)

  • Beck Depression Inventory

    Measured at Month 24

  • Oswestry Low Back Pain Disability Scale

    Measured at Month 24

  • MODEMS questionnaires

    Measured at Month 24

  • Physical impairments and function, including lower leg strength, reflexes, walking tolerance on a treadmill, and two-stage treadmill test

    Measured at Month 24

Study Arms (2)

1

EXPERIMENTAL

Participants will undergo surgery for spinal stenosis. Participants in this group will undergo surgical decompression as described by Rothman and Simeone.

Procedure: Surgical decompression

2

EXPERIMENTAL

Participants will undergo physical therapy for spinal stenosis. These participants will undergo a physical therapy program emphasizing lumbar flexion exercises, general conditioning exercises, and patient education for six weeks, with a frequency of 1-2 visits per week. Each patient will receive instruction in a home exercise program.

Procedure: Physical therapy

Interventions

Surgical decompressionPROCEDURE

Simple decompression not requiring fusion.

Also known as: Laminectomy, Foraminotomy
1
Physical therapyPROCEDURE

2 physical therapy sessions per week for 6 weeks Followed by home program.

Also known as: Exercises, Aerobics, Strengthening
2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Imaging evidence of stenosis
  • Unable to walk more than 1/4 of a mile
  • No prior surgery for stenosis
  • Consents to surgery
  • Speaks English

You may not qualify if:

  • Presence of dementia or organic brain syndrome
  • Coronary artery disease, recent myocardial infarction, pulmonary or vascular disease
  • Spondylolisthesis (\> 5 mm slippage)
  • Severe osteoporosis
  • Metastatic cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

  • Delitto A, Piva SR, Moore CG, Fritz JM, Wisniewski SR, Josbeno DA, Fye M, Welch WC. Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial. Ann Intern Med. 2015 Apr 7;162(7):465-73. doi: 10.7326/M14-1420.

    PMID: 25844995DERIVED

MeSH Terms

Conditions

Spinal StenosisSpinal Diseases

Interventions

Decompression, SurgicalLaminectomyForaminotomyPhysical Therapy ModalitiesExerciseResistance Training

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeOrthopedic ProceduresTherapeuticsNeurosurgical ProceduresRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyAftercareContinuity of Patient CarePatient CarePhysical Conditioning, Human

Study Officials

  • Anthony Delitto, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2001

First Posted

August 15, 2001

Study Start

September 1, 2000

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 27, 2013

Record last verified: 2013-02

Locations

US(1)