Lumbar Spinal StenosisNCT03365401
Efficiency of Surgical Treatment for Lumbar Spinal Stenosis
A study testing decompression surgery and nonsurgical treatment in people with Lumbar Spinal Stenosis, run by Peking University People's Hospital.
Trial summary
Decompression surgery has proved to be effective for Lumbar Spinal Stenosis (LSS) with persistent pain. But the efficiency of the surgery for degenerated LSS remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- decompression surgery and nonsurgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to 1 Feb 2020
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical symptoms: back pain radiation to lower limbs or buttocks; fatigue or loss of sensation in the lower limbs aggravated by walking.
- Persistent pain without progressive neurologic dysfunction
- Duration of symptoms and signs for more than 6 months
- Severity of the disease justifying either surgical or nonoperative treatment
Who cannot join
- severe LSS with intractable pain and progressive neurologic dysfunction, suggesting forthcoming surgical treatment
- spinal stenosis not caused by degeneration
- lumbar herniated disc diagnosed during the last 12 months
- neurologic disease causing impaired function of the lower limbs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Surgical Treatment Versus Nonoperative Treatment in Lumbar Spinal Stenosis: a Multicenter Open-label Randomized Controlled Trial
Decompression surgery has proved to be effective for Lumbar Spinal Stenosis (LSS) with persistent pain. But the efficiency of the surgery for degenerated LSS remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to surgical group or a nonoperative group. Because of the procedure , neither patients nor investigators were blinded. The primary outcome is the change of symptom measure by the Oswestry disability index 6, 12, and 24 months after procedure.
Read the detailed description
This study will use a randomised controlled trial to access the efficiency of the surgery for degenerated LSS. Patients aged 50 years or older, had LSS will be invited to take part. Patients will be randomised divided into 2 arms. The participants in the intervention arm will have decompression surgery ; those randomised to the control arm will receive current standard conservative treatment methods.
Patients were clinically assessed at baseline (the day of surgery or treatment), and at 6,12 and 24 months afterwards. The primary outcome will be the pain release , categorised according to Oswestry disability index.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- decompression surgery, nonsurgical treatment
- Keywords
- surgery, decompression
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decompression surgeryProcedure or surgery
undertake decompression surgery
nonsurgical treatmentProcedure or surgery
complete on bed with prevention of complication
| Study group | Role | What they receive |
|---|---|---|
| grade 1 | Experimental | Decompression surgery Receives: Procedure: decompression surgery |
| grade 2 | Active comparator | nonsurgical treatment Receives: Procedure: nonsurgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of symptoms
Oswestry disability index (ODI)
Measured: 6, 12, and 24 months
Secondary outcomes (1)
change of pain relief
World Health Organization pain classification
Measured: 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Feb 2018 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Haiying, Peking University People's Hospital
- Investigators
- haiying liu, Study director, pekingUPH department of spinal surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365401
- Sponsor's protocol ID
- LSS011
- Status last verified
- Dec 2017
- First submitted
- 2 Dec 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment Versus Nonoperative Treatment in Lumbar Spinal Stenosis: a Multicenter Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03365401
- Acronym / sponsor ID
- LSS011
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- surgery, decompression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 7 Dec 2017 (actual)
- 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.
Decompression surgery has proved to be effective for Lumbar Spinal Stenosis (LSS) with persistent pain. But the efficiency of the surgery for degenerated LSS remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to surgical group or a nonoperative group. Because of the procedure , neither patients nor investigators were blinded. The primary outcome is the change of symptom measure by the Oswestry disability index 6, 12, and 24 months after procedure.
Detailed description
This study will use a randomised controlled trial to access the efficiency of the surgery for degenerated LSS. Patients aged 50 years or older, had LSS will be invited to take part. Patients will be randomised divided into 2 arms. The participants in the intervention arm will have decompression surgery ; those randomised to the control arm will receive current standard conservative treatment methods.
Patients were clinically assessed at baseline (the day of surgery or treatment), and at 6,12 and 24 months afterwards. The primary outcome will be the pain release , categorised according to Oswestry disability index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| grade 1 | Experimental | Procedure: decompression surgeryDecompression surgery |
| grade 2 | Active comparator | Procedure: nonsurgical treatmentnonsurgical treatment |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical symptoms: back pain radiation to lower limbs or buttocks; fatigue or loss of sensation in the lower limbs aggravated by walking.
- Persistent pain without progressive neurologic dysfunction
- Duration of symptoms and signs for more than 6 months
- Severity of the disease justifying either surgical or nonoperative treatment
Key exclusion criteria (4 listed)
- severe LSS with intractable pain and progressive neurologic dysfunction, suggesting forthcoming surgical treatment
- spinal stenosis not caused by degeneration
- lumbar herniated disc diagnosed during the last 12 months
- neurologic disease causing impaired function of the lower limbs
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 |
|---|---|---|
| decompression surgeryundertake decompression surgery | Procedure or surgery | grade 1 |
| nonsurgical treatmentcomplete on bed with prevention of complication | Procedure or surgery | grade 2 |
Primary outcome
change of symptoms
Time frame: 6, 12, and 24 months
Oswestry disability index (ODI)
1 secondary outcome
change of pain relief
Time frame: 6, 12, and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Lumbar Spinal Stenosis
Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis
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.
haiying liu study director
pekingUPH department of spinal surgery
Questions about this trial
What is this clinical trial studying?
A study testing decompression surgery and nonsurgical treatment in people with Lumbar Spinal Stenosis, run by Peking University People's Hospital.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chen guo (8618055644700, fantasy_g@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of symptoms (time frame: 6, 12, and 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 7 Dec 2017.