Surgical Versus Nonsurgical Treatment for Spinal Stenosis

NCT ID: NCT00022776

Last Updated: 2013-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2007-12-31

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.

Conditions

Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Surgical decompression

Intervention Type: PROCEDURE

Simple decompression not requiring fusion.

2

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.

Group Type: EXPERIMENTAL

Physical therapy

Intervention Type: PROCEDURE

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

Interventions

Surgical decompression

Simple decompression not requiring fusion.

Intervention Type: PROCEDURE

Physical therapy

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

Intervention Type: PROCEDURE

Other Intervention Names

Laminectomy; Foraminotomy; Exercises; Aerobics; Strengthening

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Delitto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25844995 (View on PubMed)

Other Identifiers

R01AR045622

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01 AR45633

Identifier Type: -

Identifier Source: org_study_id