Lumbar Spinal StenosisNCT01943435
Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)
A study testing NSAIDs; adjunctive analgesics; adjunctive anti-depressants, Lumbar epidural injection and Joint Mobilizations (spine, sacroiliac, hip) in people with Lumbar Spinal Stenosis, run by Michael Schneider, DC, PhD at 1 site in United States.
Trial summary
BACKGROUND: Lumbar spinal stenosis - known by patients as "arthritis of the spine" - is a condition that is very common; found in about 30% of older adults. It is the most common reason for people over the age of 65 to have back surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- NSAIDs; adjunctive analgesics; adjunctive anti-depressants, Lumbar epidural injection and Joint Mobilizations (spine, sacroiliac, hip)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2013to 10 Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age of 60 years
- Can read/write English and understand directions
- Diagnosis of lumbar spinal stenosis confirmed by CT or MRI scan
- Has limitation of standing and/or walking tolerance
- Willing to attend treatments 2 times per week for 6 weeks
- Ability to walk at least 50 feet without the need for a cane or walker
Who cannot join
- History of metastatic cancer
- Advised by a physician not to exercise
- History of lumbar surgery for spinal stenosis or previous lumbar fusion
- Presence of severe peripheral artery disease in legs
- Severe hypertension: Systolic > 200 mm/hg or Diastolic > 110 mm/hg
- Ankle brachial index < 0.8
- Neurologic or neurodegenerative disease other than stenosis that severly impairs the ability to walk
- Presence of cauda equina symptoms (saddle paresthesia, progressive loss of bladder/bowel function, etc)
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Shadyside Center for Integrative Medicine
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Comparison of Non-Surgical Treatment Methods for Patients With Lumbar Spinal Stenosis
BACKGROUND: Lumbar spinal stenosis - known by patients as "arthritis of the spine" - is a condition that is very common; found in about 30% of older adults. It is the most common reason for people over the age of 65 to have back surgery. Some patients with stenosis do not need back surgery and can be treated with other methods, such as physical therapy, chiropractic, exercise, and medication. But we just don't have enough good research to tell us which treatment works best for which patient and under which circumstances. This research study hopes to provide more information about the effectiveness of the various non-surgical choices for managing stenosis.
OBJECTIVES: This study will directly compare the effectiveness of three common non-surgical treatment approaches for stenosis:
Read more
- Medical care that involves prescription medications and/or spinal injections (epidurals)
- Group exercise in supervised classes given in a community center setting
- Hands-on (manual) therapy and rehabilitative exercises given in a clinic setting by physical therapists and chiropractors
METHODS: This research study will involve 259 adults who are at least 60 years old and have been diagnosed with lumbar spinal stenosis. The research volunteers will be divided into three groups, each group receiving one of the 3 types of treatments listed above under "Objectives". The determination of which type of treatment each person receives will be determined by chance, using a computerized version of flipping a coin. This is a process known as randomization, which scientists think reduces the bias in research studies. A series of tests and questionnaires will be given to the patients before and after they get treatment and comparisons will be made to see how much improvement they made with each of the types of treatments. Finally, the researchers will compare the differences between the 3 treatment groups to see if certain types of treatment produced better results than others, and if there were any examination findings that could be used to predict which type of patient would do better with which type of treatment.
Read the detailed 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 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.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- NSAIDs; adjunctive analgesics; adjunctive anti-depressants, Lumbar epidural injection, Joint Mobilizations (spine, sacroiliac, hip), Individualized exercises: clinical setting, Group Exercise: community setting
- Keywords
- Spinal Stenosis, Spinal manipulation, Exercise, Epidural injection
- Medical subject headings
- Spinal Stenosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDs; adjunctive analgesics; adjunctive anti-depressantsDrug
Also called ibuprofen, celecoxib, diclofenac, misoprostol
Physician will administer these medications based upon the individual needs of each patient.
Lumbar epidural injectionProcedure or surgery
The attending physician may refer subjects for epidural injections at a pain clinic that is affiliated with the University of Pittsburgh Medical Center. All epidural injections will be provided by licensed physicians who are board certified in physical medicine and rehabilitation or anesthesiology.
Joint Mobilizations (spine, sacroiliac, hip)Other
These joint mobilizations will be applied manually to the lumbar facet joints, sacroiliac joints, and/or hip joints by licensed physical therapists and chiropractors.
Individualized exercises: clinical settingOther
The treating physical therapist or chiropractor will work with each subject to develop a set of individualized exercises in the clinic setting. The goal is to have the subjects continue these exercises at home.
Group Exercise: community settingOther
The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers.
| Study group | Role | What they receive |
|---|---|---|
| Medical Care | Active comparator | Non-steroidal anti-inflammatory drugs (NSAIDs); adjunctive analgesics; adjunctive anti-depressants. Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient.
* NSAIDs: ibuprofen, celecoxib, or diclofenac/misoprostol
* Adjunctive analgesics: acetaminophen, tramadol, or gabapentin
* Adjunctive antidepressant agents: nortriptyline, duloxetine, sertraline, trazodone, or mirtazapine
Lumbar epidural injection: these will be prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Receives: Drug: NSAIDs; adjunctive analgesics; adjunctive anti-depressants; Procedure: Lumbar epidural injection |
| Group Exercise | Active comparator | Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function. Receives: Other: Group Exercise: community setting |
| Manual therapy and exercise | Active comparator | This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used in the physical therapy and chiropractic professions. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments will be provided by licensed physical therapists and chiropractors using a combination of Joint Mobilizations (spine, sacroiliac, hip), muscle stretching and strengthening exercises.
Individualized exercises: clinical setting. These exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor. Receives: Other: Joint Mobilizations (spine, sacroiliac, hip); Other: Individualized exercises: clinical setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swiss Spinal Stenosis (SSS) Questionnaire Score
Our primary aim included a primary outcome measure of self-reported pain/function, which was the change in SSS total score between baseline and 8 weeks. The Swiss Spinal Stenosis Questionnaire (SSS) is a validated 12-item condition-specific instrument for patients with lumbar spinal stenosis. It provides a patient self-report measure of pain and physical function. Higher scores represent worse symptoms and less physical function. The 12-item SSS total score range is 12-55. For our analysis, we compared the change in the 12-item Total score from baseline to 8 weeks.
Measured: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).
Secondary outcomes (1)
Self Paced Walking Test (SPWT)
Our primary aim also included a performance-based outcome measure, which was the distance walked during the SPWT. The analysis was a comparison of between-group changes in SPWT between baseline and 8 weeks. The Self-Paced Walking Test (SPWT) is a validated objective measure of a patient's walking capacity, which is performed on a level walking surface. The patient is instructed to walk at their own pace and to stop when the symptoms are troublesome enough that s/he needs to sit down to rest. The total time and total distance walked are measured by the research assistant. Our unit of measure was the total distance walked, expressed in meters.
Measured: Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study start20 Nov 2013
- Primary completion7 Jun 2016
- Study completion10 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Schneider, DC, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, Michael Schneider, DC, PhD, University of Pittsburgh
- Investigators
- Michael J Schneider, PhD, DC, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943435
- Sponsor's protocol ID
- PRO12120422
- Other IDs
- 587
- Status last verified
- Mar 2018
- First submitted
- 8 Sep 2013
- Last updated
- 2 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data may be shared with other researchers at the discretion and approval of the PI.
Publications
Schneider M, Ammendolia C, Murphy D, Glick R, Piva S, Hile E, Tudorascu D, Morton SC. Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized controlled trial. Chiropr Man Therap. 2014 May 10;22:19. doi: 10.1186/2045-709X-22-19. eCollection 2014.
PubMed 24872875Roseen EJ, Smith CN, Rahim A, Deal C, Fischer R, Morone NE, Flack A, Penza C, Suri P, Dougherty PE, Weiner DK, Schneider MJ. Which lumbar spinal stenosis patients will improve with nonsurgical treatment? A secondary analysis of a randomized controlled trial. Chiropr Man Therap. 2025 Dec 9;33(1):57. doi: 10.1186/s12998-025-00620-0.
PubMed 41366694Schneider MJ, Ammendolia C, Murphy DR, Glick RM, Hile E, Tudorascu DL, Morton SC, Smith C, Patterson CG, Piva SR. Comparative Clinical Effectiveness of Nonsurgical Treatment Methods in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186828. doi: 10.1001/jamanetworkopen.2018.6828.
PubMed 30646197
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Non-Surgical Treatment Methods for Patients With Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT01943435
- Acronym / sponsor ID
- PRO12120422
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Spinal Stenosis, Spinal manipulation, Exercise, Epidural injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Michael Schneider, DC, PhDUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 20 Nov 2013 (actual)
- Primary completion
- 7 Jun 2016 (actual)
- Study completion
- 10 Jun 2016 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND: Lumbar spinal stenosis - known by patients as "arthritis of the spine" - is a condition that is very common; found in about 30% of older adults. It is the most common reason for people over the age of 65 to have back surgery. Some patients with stenosis do not need back surgery and can be treated with other methods, such as physical therapy, chiropractic, exercise, and medication. But we just don't have enough good research to tell us which treatment works best for which patient and under which circumstances. This research study hopes to provide more information about the effectiveness of the various non-surgical choices for managing stenosis.
OBJECTIVES: This study will directly compare the effectiveness of three common non-surgical treatment approaches for stenosis:
- Medical care that involves prescription medications and/or spinal injections (epidurals)
- Group exercise in supervised classes given in a community center setting
- Hands-on (manual) therapy and rehabilitative exercises given in a clinic setting by physical therapists and chiropractors
METHODS: This research study will involve 259 adults who are at least 60 years old and have been diagnosed with lumbar spinal stenosis. The research volunteers will be divided into three groups, each group receiving one of the 3 types of treatments listed above under "Objectives". The determination of which type of treatment each person receives will be determined by chance, using a computerized version of flipping a coin. This is a process known as randomization, which scientists think reduces the bias in research studies. A series of tests and questionnaires will be given to the patients before and after they get treatment and comparisons will be made to see how much improvement they made with each of the types of treatments. Finally, the researchers will compare the differences between the 3 treatment groups to see if certain types of treatment produced better results than others, and if there were any examination findings that could be used to predict which type of patient would do better with which type of treatment.
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medical Care | Active comparator | Drug: NSAIDs; adjunctive analgesics; adjunctive anti-depressants, Procedure: Lumbar epidural injectionNon-steroidal anti-inflammatory drugs (NSAIDs); adjunctive analgesics; adjunctive anti-depressants. Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. * NSAIDs: ibuprofen, celecoxib, or diclofenac/misoprostol * Adjunctive analgesics: acetaminophen, tramadol, or gabapentin * Adjunctive antidepressant agents: nortriptyline, duloxetine, sertraline, trazodone, or mirtazapine Lumbar epidural injection: these will be prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. |
| Group Exercise | Active comparator | Other: Group Exercise: community settingGroup Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function. |
| Manual therapy and exercise | Active comparator | Other: Joint Mobilizations (spine, sacroiliac, hip), Other: Individualized exercises: clinical settingThis group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used in the physical therapy and chiropractic professions. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments will be provided by licensed physical therapists and chiropractors using a combination of Joint Mobilizations (spine, sacroiliac, hip), muscle stretching and strengthening exercises. Individualized exercises: clinical setting. These exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Minimum age of 60 years
- Can read/write English and understand directions
- Diagnosis of lumbar spinal stenosis confirmed by CT or MRI scan
- Has limitation of standing and/or walking tolerance
- Willing to attend treatments 2 times per week for 6 weeks
Key exclusion criteria (8 listed)
- History of metastatic cancer
- Advised by a physician not to exercise
- History of lumbar surgery for spinal stenosis or previous lumbar fusion
- Presence of severe peripheral artery disease in legs
- Severe hypertension: Systolic > 200 mm/hg or Diastolic > 110 mm/hg
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 |
|---|---|---|
| NSAIDs; adjunctive analgesics; adjunctive anti-depressantsAlso: ibuprofen, celecoxib, diclofenac, misoprostolPhysician will administer these medications based upon the individual needs of each patient. | Drug | Medical Care |
| Lumbar epidural injectionThe attending physician may refer subjects for epidural injections at a pain clinic that is affiliated with the University of Pittsburgh Medical Center. All epidural injections will be provided by licensed physicians who are board certified in physical medicine and rehabilitation or anesthesiology. | Procedure or surgery | Medical Care |
| Joint Mobilizations (spine, sacroiliac, hip)These joint mobilizations will be applied manually to the lumbar facet joints, sacroiliac joints, and/or hip joints by licensed physical therapists and chiropractors. | Other | Manual therapy and exercise |
| Individualized exercises: clinical settingThe treating physical therapist or chiropractor will work with each subject to develop a set of individualized exercises in the clinic setting. The goal is to have the subjects continue these exercises at home. | Other | Manual therapy and exercise |
| Group Exercise: community settingThe group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers. | Other | Group Exercise |
Primary outcome
Swiss Spinal Stenosis (SSS) Questionnaire Score
Time frame: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).
Our primary aim included a primary outcome measure of self-reported pain/function, which was the change in SSS total score between baseline and 8 weeks. The Swiss Spinal Stenosis Questionnaire (SSS) is a validated 12-item condition-specific instrument for patients with lumbar spinal stenosis. It provides a patient self-report measure of pain and physical function. Higher scores represent worse symptoms and less physical function. The 12-item SSS total score range is 12-55. For our analysis, we compared the change in the 12-item Total score from baseline to 8 weeks.
1 secondary outcome
Self Paced Walking Test (SPWT)
Time frame: Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24872875Schneider M, Ammendolia C, Murphy D, Glick R, Piva S, Hile E, Tudorascu D, Morton SC. Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized controlled trial. Chiropr Man Therap. 2014 May 10;22:19. doi: 10.1186/2045-709X-22-19. eCollection 2014.
- Derived from this study: PubMed 41366694Roseen EJ, Smith CN, Rahim A, Deal C, Fischer R, Morone NE, Flack A, Penza C, Suri P, Dougherty PE, Weiner DK, Schneider MJ. Which lumbar spinal stenosis patients will improve with nonsurgical treatment? A secondary analysis of a randomized controlled trial. Chiropr Man Therap. 2025 Dec 9;33(1):57. doi: 10.1186/s12998-025-00620-0.
- Derived from this study: PubMed 30646197Schneider MJ, Ammendolia C, Murphy DR, Glick RM, Hile E, Tudorascu DL, Morton SC, Smith C, Patterson CG, Piva SR. Comparative Clinical Effectiveness of Nonsurgical Treatment Methods in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186828. doi: 10.1001/jamanetworkopen.2018.6828.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with other researchers at the discretion and approval of the PI.
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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.
Michael J Schneider, PhD, DC 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 study testing NSAIDs; adjunctive analgesics; adjunctive anti-depressants, Lumbar epidural injection and Joint Mobilizations (spine, sacroiliac, hip) in people with Lumbar Spinal Stenosis, run by Michael Schneider, DC, PhD 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 6 inclusion and 8 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 2 Apr 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Swiss Spinal Stenosis (SSS) Questionnaire Score (time frame: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).). 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 NCT01943435, which also lists 3 linked publications.
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 2 Apr 2018.