Lumbar Spinal StenosisLESSERNCT02260401
Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis
A study testing Individualized report in people with Lumbar Spinal Stenosis, run by University of Washington at 1 site in United States.
Trial summary
Spinal stenosis is one of the most common causes of low back pain among older adults and can result in significant disability. Despite this, it still isn't known which treatments are most effective or what outcomes are most important to these older adults. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Individualized report
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Sep 2015
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients already enrolled in the LESS trial will be eligible for participation in the LESSER trial
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Spinal stenosis is one of the most common causes of low back pain among older adults and can result in significant disability. Despite this, it still isn't known which treatments are most effective or what outcomes are most important to these older adults. Through a Patient Centered Outcomes Research Institute (PCORI) contract, the investigators are building on the existing infrastructure of an AHRQ-funded (ARRA CHOICE award) comparative effectiveness research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS trial) to address several critical research questions. The proposed study will answer the following key questions. Do decision aids tailored to older adults with spinal stenosis change patient decision-making regarding subsequent treatments? Do patients respond differently at subsequent outcome assessments time-points after receiving tailored decision aids that contain their own individual outcome data from prior treatments? The investigators hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.
Read the detailed description
LESS trial participants will be randomized to receive the individualized outcome report before the 18-month interview or after the 24-month follow up. Both groups will be asked to rank outcome domains of most importance to them, to answer questions regarding their beliefs about receiving future treatments for spinal stenosis and to complete the standard self-reported outcomes questionnaire. In addition, we will ask the study participants whether the information presented in the individualized report was helpful in deciding their future epidural injection treatments as well as if the content of the reports was easy to understand. At 24 months, we will repeat the interview and the outcomes assessment. We will again compare the groups in terms of their responses to determine if there are lasting differences in how patients who received the individualized reports make decisions regarding future treatments and respond to the self-reported outcomes questions. In addition, we will compare healthcare utilization between the two groups from 18 months to 24 months to determine if providing the individualized outcomes reports changed treatment utilization (i.e., do people who receive the report undergo fewer subsequent injections or other treatments for pain?). We hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Individualized report
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized reportOther
Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)
| Study group | Role | What they receive |
|---|---|---|
| Individualized report | Experimental | Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months. Receives: Other: Individualized report |
| Individualized Reports after 24 months | No intervention | Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of ESI
We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months
Measured: 24 months
Secondary outcomes (1)
Healthcare Utilization
We will determine if providing individualized reports to the LESS trial participants at 198 months impacts healthcare utilization for spinal stenosis between 18 and 24 months (including doctors visits, physical therapy, surgery, opioid use)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionSep 2015
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.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Janna Friedly, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260401
- Sponsor's protocol ID
- 39023
- Acronym
- LESSER
- Status last verified
- Mar 2017
- First submitted
- 5 Oct 2014
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis
- ClinicalTrials.gov ID
- NCT02260401
- Acronym / sponsor ID
- LESSER / 39023
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spinal stenosis is one of the most common causes of low back pain among older adults and can result in significant disability. Despite this, it still isn't known which treatments are most effective or what outcomes are most important to these older adults. Through a Patient Centered Outcomes Research Institute (PCORI) contract, the investigators are building on the existing infrastructure of an AHRQ-funded (ARRA CHOICE award) comparative effectiveness research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS trial) to address several critical research questions. The proposed study will answer the following key questions. Do decision aids tailored to older adults with spinal stenosis change patient decision-making regarding subsequent treatments? Do patients respond differently at subsequent outcome assessments time-points after receiving tailored decision aids that contain their own individual outcome data from prior treatments? The investigators hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.
Detailed description
LESS trial participants will be randomized to receive the individualized outcome report before the 18-month interview or after the 24-month follow up. Both groups will be asked to rank outcome domains of most importance to them, to answer questions regarding their beliefs about receiving future treatments for spinal stenosis and to complete the standard self-reported outcomes questionnaire. In addition, we will ask the study participants whether the information presented in the individualized report was helpful in deciding their future epidural injection treatments as well as if the content of the reports was easy to understand. At 24 months, we will repeat the interview and the outcomes assessment. We will again compare the groups in terms of their responses to determine if there are lasting differences in how patients who received the individualized reports make decisions regarding future treatments and respond to the self-reported outcomes questions. In addition, we will compare healthcare utilization between the two groups from 18 months to 24 months to determine if providing the individualized outcomes reports changed treatment utilization (i.e., do people who receive the report undergo fewer subsequent injections or other treatments for pain?). We hypothesize that providing these individualized reports will allow patients to make more informed choices regarding subsequent treatments, leading to reduced use of ineffective treatments and improved outcomes overall.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized report | Experimental | Other: Individualized reportEach patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months. |
| Individualized Reports after 24 months | No intervention | –Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients already enrolled in the LESS trial will be eligible for participation in the LESSER trial
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Individualized reportEach patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections) | Other | Individualized report |
Primary outcome
Utilization of ESI
Time frame: 24 months
We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months
1 secondary outcome
Healthcare Utilization
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized report in people with Lumbar Spinal Stenosis, run by University of Washington 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 1 inclusion and 1 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 16 Jun 2017. 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 16 Jun 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?
Utilization of ESI (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2017; AzTrials last refreshed its copy on 7 Nov 2026.