Surgical Versus Nonsurgical Treatment for Spinal Stenosis | NCT00022776

Studies
Surgical Versus Nonsurgical Treatment for Spinal Stenosis

NCT00022776

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Feb 27, 2013Estimated

Enrollment

178Actual

Phase

Phase 3

Conditions

Spinal Stenosis

Interventions

Surgical decompression
Physical therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01AR045622	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2000

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Aug 13, 2001

First Submission Date that Met QC Criteria

Aug 14, 2001

First Posted Date

Aug 15, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2013

Last Update Posted Date

Feb 27, 2013Estimated

Name	Class
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Lumbar spinal stenosis is a frequently encountered condition, particularly in the elderly, which can lead to significant pain and functional limitations. The prevalence of this condition is growing as the population continues to age. Substantial controversy exists regarding the management of lumbar spinal stenosis. Surgery has traditionally been the treatment of choice, although physicians typically recommend a trial of nonsurgical care prior to surgery. The most effective means of nonsurgical treatment has not been identified, although a "standard" regimen has been developed.

There is presently no evidence in the literature regarding the relative effectiveness of surgical versus nonsurgical treatment of lumbar spinal stenosis, or the efficacy of the standard nonsurgical treatment approach. This randomized clinical trial will compare surgical decompression versus nonsurgical treatment (i.e., physical therapy) of lumbar spinal stenosis. The results of this study should help clarify which treatment strategies are the most effective for patients with lumbar spinal stenosis.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

178Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Surgical decompression	Procedure	Simple decompression not requiring fusion.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medical Outcomes Study 36-item Short Form Health Survey		Measured at Month 24

Secondary Outcomes

Measure	Description	Time Frame
Beck Depression Inventory		Measured at Month 24
Oswestry Low Back Pain Disability Scale		Measured at Month 24
MODEMS questionnaires

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anthony Delitto, PhD	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh		Pittsburgh	Pennsylvania	15260	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25844995	Derived	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.

ID	Term
D013130	Spinal Stenosis
D013122	Spinal Diseases

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

ID	Term
D019299	Decompression, Surgical
D007796	Laminectomy
D059526	Foraminotomy
D026741	Physical Therapy Modalities
D015444	Exercise
D055070	Resistance Training

ID	Term
D013514	Surgical Procedures, Operative
D019637	Orthopedic Procedures
D013812	Therapeutics
D019635	Neurosurgical Procedures