Lumbar Spinal StenosisNCT02134821
Influence of Pain Sensitivity on Lumbar Surgery Outcomes
An observational study of Lumbar Spinal Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Surgery for lumbar spinal stenosis
- Type of treatment
- Surgery or procedure
- How many people
- 171 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Apr 2014
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The inclusion criteria were the following: 1) patients aged 40-80 years; 2) an lumbar spinal stenosis diagnosis and scheduled spine surgery at a tertiary-care teaching institution between June 2012 and April 2013
Who may be able to join
- patients aged 40-80 years
- lumbar spinal stenosis diagnosis and scheduled spine surgery at a tertiary-care teaching institution between June 2012 and April 2013
Who cannot join
- a history of major psychiatric disorders (schizophrenia, major depression) or peripheral vascular disease
- any concurrent serious medical condition that would cause disability or decreased general health status such as sepsis or cancer.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Sung-Nam, Gyeonggi-do, 463-707
About this study
Official title: Influence of Pain Sensitivity on Surgical Outcomes After Lumbar Spine Surgery in Patients With Lumbar Spinal Stenosis
Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Surgery for lumbar spinal stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for lumbar spinal stenosisProcedure or surgery
decompression with or without fusion for lumbar spinal stenosis
| Study group | Role | What they receive |
|---|---|---|
| Low pain sensitivity group | total Pain Sensitivity Questionnaire score <6.5 Receives: Procedure: Surgery for lumbar spinal stenosis | |
| High pain sensitivity group | total pain sensitivity questionnaire score ≥ 6.5 Receives: Procedure: Surgery for lumbar spinal stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
Measured: up to 12 months after operation
Secondary outcomes (3)
Visual Analog Pain Scale for back pain
Measured: up to 12 months after operation
Visual Analog Pain Scale for leg pain
Measured: up to 12 months after operation
Short-Form 36
measurement of general health status
Measured: up to 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJun 2012
- Primary completionApr 2014
- Study completionApr 2014
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 Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin S. Yeom, Seoul National University Hospital
- Investigators
- Jin S. Yeom, MD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134821
- Sponsor's protocol ID
- PSQ_001
- Status last verified
- May 2014
- First submitted
- 6 May 2014
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim HJ, Park JW, Kang KT, Chang BS, Lee CK, Kang SS, Yeom JS. Determination of the Optimal Cutoff Values for Pain Sensitivity Questionnaire Scores and the Oswestry Disability Index for Favorable Surgical Outcomes in Subjects With Lumbar Spinal Stenosis. Spine (Phila Pa 1976). 2015 Oct 15;40(20):E1110-6. doi: 10.1097/BRS.0000000000001023.
PubMed 26076437
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pain Sensitivity on Surgical Outcomes After Lumbar Spine Surgery in Patients With Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT02134821
- Acronym / sponsor ID
- PSQ_001
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 May 2014 (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.
Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low pain sensitivity group | – | Procedure: Surgery for lumbar spinal stenosistotal Pain Sensitivity Questionnaire score <6.5 |
| High pain sensitivity group | – | Procedure: Surgery for lumbar spinal stenosistotal pain sensitivity questionnaire score ≥ 6.5 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The inclusion criteria were the following: 1) patients aged 40-80 years; 2) an lumbar spinal stenosis diagnosis and scheduled spine surgery at a tertiary-care teaching institution between June 2012 and April 2013
Key inclusion criteria (2 listed)
- patients aged 40-80 years
- lumbar spinal stenosis diagnosis and scheduled spine surgery at a tertiary-care teaching institution between June 2012 and April 2013
Key exclusion criteria (2 listed)
- a history of major psychiatric disorders (schizophrenia, major depression) or peripheral vascular disease
- any concurrent serious medical condition that would cause disability or decreased general health status such as sepsis or 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 |
|---|---|---|
| Surgery for lumbar spinal stenosisdecompression with or without fusion for lumbar spinal stenosis | Procedure or surgery | High pain sensitivity group, Low pain sensitivity group |
Primary outcome
Oswestry Disability Index
Time frame: up to 12 months after operation
3 secondary outcomes
Visual Analog Pain Scale for back pain
Time frame: up to 12 months after operation
Visual Analog Pain Scale for leg pain
Time frame: up to 12 months after operation
Short-Form 36
Time frame: up to 12 months after operation
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 9 May 2014.
- Derived from this study: PubMed 26076437Kim HJ, Park JW, Kang KT, Chang BS, Lee CK, Kang SS, Yeom JS. Determination of the Optimal Cutoff Values for Pain Sensitivity Questionnaire Scores and the Oswestry Disability Index for Favorable Surgical Outcomes in Subjects With Lumbar Spinal Stenosis. Spine (Phila Pa 1976). 2015 Oct 15;40(20):E1110-6. doi: 10.1097/BRS.0000000000001023.
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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.
Jin S. Yeom, MD study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 2 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 9 May 2014. 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 South Korea. 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?
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?
Oswestry Disability Index (time frame: up to 12 months after operation). 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 NCT02134821, 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 9 May 2014.