Spinal StenosisPhase 3NCT00022776
Surgical Versus Nonsurgical Treatment for Spinal Stenosis
A Phase 3 study testing Surgical decompression and Physical therapy in people with Spinal Stenosis, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Surgical decompression and Physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Imaging evidence of stenosis
- Unable to walk more than 1/4 of a mile
- No prior surgery for stenosis
- Consents to surgery
- Speaks English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Randomized Clinical Trial of Treatment for Spinal Stenosis
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.
Read the 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
- Being tested
- Surgical decompression, Physical therapy
- Keywords
- Human therapy evaluation, Orthopedics, Physical therapy, Nonsurgical treatment, Surgical decompression, Surgery, Lumbar, Spine disorder, Spinal stenosis, Gender difference, Medical rehabilitation
- Medical subject headings
- Spinal Stenosis, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical decompressionProcedure or surgery
Also called Laminectomy, Foraminotomy
Simple decompression not requiring fusion.
Physical therapyProcedure or surgery
Also called Exercises, Aerobics, Strengthening
2 physical therapy sessions per week for 6 weeks Followed by home program.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will undergo surgery for spinal stenosis. Participants in this group will undergo surgical decompression as described by Rothman and Simeone. Receives: 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. Receives: Procedure: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Outcomes Study 36-item Short Form Health Survey
Measured: Measured at Month 24
Secondary outcomes (4)
Beck Depression Inventory
Measured: Measured at Month 24
Oswestry Low Back Pain Disability Scale
Measured: Measured at Month 24
MODEMS questionnaires
Measured: Measured at Month 24
Physical impairments and function, including lower leg strength, reflexes, walking tolerance on a treadmill, and two-stage treadmill test
Measured: Measured at Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2001 (estimated)
- Study startSep 2000
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Anthony Delitto, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022776
- Sponsor's protocol ID
- R01 AR45633
- Other IDs
- R01AR045622
- Status last verified
- Feb 2013
- First submitted
- 13 Aug 2001
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25844995
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Treatment for Spinal Stenosis
- ClinicalTrials.gov ID
- NCT00022776
- Acronym / sponsor ID
- R01 AR45633
- Conditions
- Spinal Stenosis
- Keywords
- Human therapy evaluation, Orthopedics, Physical therapy, Nonsurgical treatment, Surgical decompression, Surgery, Lumbar, Spine disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Sep 2000
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Surgical decompressionParticipants will undergo surgery for spinal stenosis. Participants in this group will undergo surgical decompression as described by Rothman and Simeone. |
| 2 | Experimental | Procedure: Physical therapyParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Imaging evidence of stenosis
- Unable to walk more than 1/4 of a mile
- No prior surgery for stenosis
- Consents to surgery
- Speaks English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical decompressionAlso: Laminectomy, ForaminotomySimple decompression not requiring fusion. | Procedure or surgery | 1 |
| Physical therapyAlso: Exercises, Aerobics, Strengthening2 physical therapy sessions per week for 6 weeks Followed by home program. | Procedure or surgery | 2 |
Primary outcome
Medical Outcomes Study 36-item Short Form Health Survey
Time frame: Measured at Month 24
4 secondary outcomes
Beck Depression Inventory
Time frame: Measured at Month 24
Oswestry Low Back Pain Disability Scale
Time frame: Measured at Month 24
MODEMS questionnaires
Time frame: Measured at Month 24
Physical impairments and function, including lower leg strength, reflexes, walking tolerance on a treadmill, and two-stage treadmill test
Time frame: Measured at Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
- Derived from this study: PubMed 25844995Delitto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Delitto, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgical decompression and Physical therapy in people with Spinal Stenosis, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Outcomes Study 36-item Short Form Health Survey (time frame: Measured at Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00022776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.