Spinal StenosisUppStenNCT03495661
Decompression vs Physical Training for the Treatment of Lumbar Spinal Stenosis
A study testing Decompression in people with Spinal Stenosis and Spinal Stenosis Lumbar, run by Uppsala University at 1 site in Sweden.
Trial summary
Lumbar spinal stenosis (LSS) is characterized by low back and leg pain, walking disturbances and sometimes instability, impaired balance and numbness of the lower limbs. This condition is caused by degenerative changes in the lumbar spine including bulging discs, osteophytes from the arthritic facet joints and… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Spinal Stenosis, Spinal Stenosis Lumbar, Degeneration Lumbar Spine
- What is being tested?
- Decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSweden
- Study dates
- 4 May 2018to 14 Dec 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-85 years.
- Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) that indicate and motivate surgery. NRS in lower limbs ≥3.
- MRI with finding of LSS at 1-3 lumbar levels. Dural sac area ≤ 75 mm² or degree of stenosis C or D according to Schizas classification.
- The surgical treatment to be provided is decompression alone.
- The patient has given oral and written informed consent to the participation in the study.
Who cannot join
- Degenerative deformity with Cobb angle > 20°.
- Spondylolysis.
- Symptomatic osteoarthritis in the lower limbs that affects and limits their function.
- Arterial insufficiency (claudication intermittent) .
- Past lumbar surgery other than disc hernia.
- Conditions that affect the spine such as ankylosing spondylitis, Diffuse Idiopathic Skeletal Hyperostosis (DISH), spondylodiscitis/infections, malignancy, neurological diseases.
Show all 9Show fewer
- Heart and lung diseases that present a significant risk for surgery or make it impossible for the patient to take part in physical training program (ASA>3).
- Polyneuropathies.
- Psychological factors that make the patient incapable of inclusion in the study (eg drug addiction, dementia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uppsala Spinal Stenosis Study
Lumbar spinal stenosis (LSS) is characterized by low back and leg pain, walking disturbances and sometimes instability, impaired balance and numbness of the lower limbs. This condition is caused by degenerative changes in the lumbar spine including bulging discs, osteophytes from the arthritic facet joints and thickened ligamentum flavum which together cause narrowing of the spinal canal and thus affect the lumbar nerve roots. This diagnosis is attracting more and more interest due to the aging population with increasing demands for physical activity. LSS is the most common indication for spinal surgery. The surgical treatment involves relieving the pressure from the nerve structures in the stenotic segments through a posterior approach. In several studies, surgery has been shown to have better results than the conservative treatment. However, methodological difficulties and a large proportion of cross-over in these studies indicate that there is still uncertainty about whether surgery is generally a better option.
It has been speculated whether the compression of the nerve roots causes in some patients permanent nerve damage with muscle denervation, while in other cases a reinnervation and recovery of the function may occur. Results from neurography and EMG studies have been shown these modalities to have a possible predictive value for the natural process of LSS. If a neurophysiological examination could be able to predict which patients are able to benefit from surgery, many patients could avoid surgery and the risks involved in it.
Read more
The aim of this study is primarily to evaluate whether surgery with decompression leads to superior results than the non-surgical treatment with structured physical therapy.
The main secondary aim is to investigate by means of Neurography and EMG, whether the degree of neurological affection caused by nerve compression affects the outcome of surgery for LSS.
Read the detailed description
Background
Lumbar spinal stenosis (LSS) is characterized by low back and leg pain, walking disturbances and sometimes instability, impaired balance and numbness of the lower limbs. This condition is caused by degenerative changes in the lumbar spine including bulging discs, osteophytes from the arthritic facet joints and thickened ligamentum flavum which together cause narrowing of the spinal canal and thus affect the lumbar nerve roots. LSS affects mainly older populations and is unusual under 50 years old. This diagnosis is attracting more and more interest due to the aging population with increasing demands for physical activity. LSS is the most common indication for spinal surgery. The surgical treatment involves relieving the pressure from the nerve structures in the stenotic segments through a posterior approach. The hypertrophic ligaments and parts of the facet joints are removed (i.e., decompression). Adding fusion to the decompression for stabilization of the decompressed segment has not been shown to provide superior results than decompression alone. In several studies, surgery has been shown to have better results than the conservative treatment. However, methodological difficulties and a large proportion of cross-over in these studies indicate that there is still uncertainty about whether surgery is generally a better option.
After decompression, only 60-70% of patients reported to be satisfied with the result and a minor proportion of them experienced even no improvement at all [Strömqvist]. Conservative treatment has shown in some studies to have good results for some patient groups and other studies have shown that the benefit of the surgical treatment decreases over time and that physical exercise may reduce the need for surgery. Moreover, surgery itself has a positive placebo effect that can improve symptoms in some diseases.
It has been speculated whether the compression of the nerve roots causes in some patients permanent nerve damage with muscle denervation, while in other cases a reinnervation and recovery of the function may occur. Results from neurography and EMG studies have been shown these modalities to have a possible predictive value for the natural process of LSS. If a neurophysiological examination could be able to predict which patients are able to benefit from surgery, many patients could avoid surgery and the risks involved in it.
The degeneration of the lumbar spine is progressively impairing the spinal sagittal balance. The need to make extensive correction and fusion in addition to the decompression in order to restore the sagittal balance is debated among spinal surgeons. The experience gained from previous RCTs is that the patients' back pain is reduced by decompression only. Many patients also report that their posture improved after decompression alone.
Previous trials in the connective tissue and blood samples have shown that proinflammatory factors and nociceptors (molecules that induce pain) are upregulated in patients with patellar tendinosis which is an inflammatory condition. Changes in the connective tissue that cause LSS are mainly inflammatory (arthritic facet joints and ligamentum flavum) and a possible theory around LSS pathophysiology may be that the nerves are biologically affected by proinflammatory factors and nociceptors. Identification of some of these factors could lead to better explanation of the pathomechanism behind the nerve compression in LSS and to the development of future pharmacological treatments to be used in conjunction with surgery.
Aims
The aim of this study is primarily to evaluate whether surgery with decompression leads to superior results than the non-surgical treatment with structured physical therapy. For this evaluation, the Oswestry Disability Index (ODI) will be used.
The main secondary aim is to investigate by means of Neurography and EMG, whether the degree of neurological affection caused by nerve compression affects the outcome of surgery for LSS.
Aims The aim of this study is primarily to evaluate whether surgery with decompression leads to superior results than the non-surgical treatment with structured physical therapy. For his evaluation, the Oswestry Disability Index (ODI) will be used.
The main secondary aim is to investigate by means of Neurography and EMG, whether the degree of neurological affection caused by nerve compression affects the outcome of surgery for LSS.
The questions at issue are:
- Does decompression provide a better clinical outcome than the non-surgical treatment?
- Is there any correlation between the clinical grade of symptoms and the degree of neurological affection measured by ENG/EMG?
- Is there any connection between the neurological affection and the proinflammatory markers/nociceptors in the blood as well as in histological findings from ligamentum flavum? Are these correlated with the clinical grade of symptoms?
- Does decompression provide superior neurological recovery, measured by ENG/EMG, in comparison to the non-surgical treatment ?
- Can decompression improve the spinal sagittal balance?
Follow-up 6 months, 1, 2 and 5 years
The results at 2 years will be the most important goal of the study, on which the main clinical results will be built. The neurophysiological results can be analyzed and presented after the 6-month follow up.
Flow-chart
Recruitment The patient is recruited during an outpatient visit to a surgeon. Oral and written information about the study is given.
ICF The patient gives oral and written consent. The consent is documented in the patient journal and the written consent is filed in the study document binder.
Baseline data - PROMs via Swespine Study
- 6MWT
- Scoliosis standing digital X-rays (AP and lateral views)
- ENG/EMG
- Blood samples for analysis of inflammatory markers (OLINK)
Randomizing Simple block randomization to the two treatment arms.
Treatment arms A. Decompression. Central decompression of the stenotic segments with undercutting of the lateral recesses, free mobilization, and routine follow-up postoperatively by physiotherapist.
- Non-surgical treatment. Exercise on exercise bike according to the "Östersund model" [Nord] 30 min, 3 times/week for 4 months.
Follow-up 6 months - PROMs via Swespine Study
- 6MWT
- Scoliosis standing digital X-rays (AP and lateral views)
- ENG/EMG
- Blood samples for analysis of inflammatory markers (OLINK)
Cross-over Feasibility for cross-over from group B till A after 6-month follow-up.
Follow-up 1,2 years - PROMs via Swespine Study
- 6MWT
Follow -up 5 years - PROMs via Swespine Study
In the treatment group A, in conjunction with the surgical procedure, ligamentum flavum will be collected (which is usually removed during the decompression surgery) and will be examined with histological methods regarding proinflammatory markers and nociceptors . An 1x1 cm tissue piece will be dissected and saved. The ligament samples will be examined by immunohistochemistry and with proteomics analysis. Proteomics analysis will be performed in collaboration with Olink Uppsala (www.olink.com) where 92 inflammation-related factors will be investigated. Sample management will be in accordance with the Ethics Examination Act of Human Research (2003: 460) and according to the rules of Uppsala Biobank.
- Conditions
- Spinal Stenosis, Spinal Stenosis Lumbar, Degeneration Lumbar Spine, Degeneration Spine, Neurogenic Claudication Co-Occurrent and Due to Spinal Stenosis of Lumbar Region, Pseudoclaudication Syndrome
- Being tested
- Decompression
- Keywords
- lumbar spine stenosis, decompression, laminectomy, physiotherapy, physical therapy, electroneurography, ENG, electromyography, EMG, Neurogenic Claudication, Pseudoclaudication
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecompressionProcedure or surgery
Also called Laminectomy
Central decompression of the stenotic segment(s) with undercutting of the lateral recesses.
| Study group | Role | What they receive |
|---|---|---|
| Surgical (Decompression) | Active comparator | Central decompression of the stenotic segment(s) with undercutting of the lateral recesses. Receives: Procedure: Decompression |
| Non-surgical | No intervention | Physical therapy according to the "Östersund model": training on stationary bicycle 30 min, 3 times/week under 4 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Through the Swedish National Spine Registry (SweSpine)
Measured: Baseline
Oswestry Disability Index (ODI)
Through the Swedish National Spine Registry (SweSpine)
Measured: 6 months
Oswestry Disability Index (ODI)
Through the Swedish National Spine Registry (SweSpine)
Measured: 1 year
Oswestry Disability Index (ODI)
Through the Swedish National Spine Registry (SweSpine)
Measured: 2 years
Oswestry Disability Index (ODI)
Through the Swedish National Spine Registry (SweSpine)
Measured: 5 years
Secondary outcomes (13)
Motor Amplitude (ENG)
Measured: Baseline and 6 months postoperatively
Denervation Activity (EMG)
Measured: Baseline and 6 months follow-up
Sensory Amplitude (ENG)
Measured: Baseline and 6 months follow-up
Late Responses (F-wave and H.Reflex)
Measured: Baseline and 6 months follow-up
Motor Unit Number Index (MUNIX)
Measured: Baseline and 6 months follow-up
Grade of Reinnervation (EMG)
Measured: Baseline and 6 months follow-up
EQ-5D
Through the Swedish National Spine Registry (SweSpine)
Measured: Baseline and 6 months, 1, 2, 5 years follow-up
NRS for Low Back and Leg Pain
Through the Swedish National Spine Registry (SweSpine)
Measured: Baseline and 6 months, 1, 2, 5 years follow-up
Subjective Walking Ability
Through the Swedish National Spine Registry (SweSpine)
Measured: Baseline and 6 months, 1, 2, 5 years follow-up
Global Assessment (GA)
Through the Swedish National Spine Registry (SweSpine)
Measured: Baseline and 6 months, 1, 2, 5 years follow-up
Patient Satisfaction
Through the Swedish National Spine Registry (SweSpine)
Measured: Baseline and 6 months, 1, 2, 5 years follow-up
Objective Walking Ability
6 Minutes Walk Test (6MWT)
Measured: Baseline and 6 months, 1, 2 years follow-up
Lumbar Lordosis (LL) and Sagittal Vertebral Axis (SVA)
Standing Scoliosis X-rays (AP and Lateral view)
Measured: Baseline and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start4 May 2018
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
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 Uppsala UniversityThe 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
- Model description
- prospective clinical randomised clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konstantinos Pazarlis, MD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495661
- Sponsor's protocol ID
- u1
- Acronym
- UppSten
- Status last verified
- Dec 2021
- First submitted
- 22 Mar 2018
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pazarlis K, Punga A, Schizas N, Sanden B, Michaelsson K, Forsth P. Study protocol for a randomised controlled trial with clinical, neurophysiological, laboratory and radiological outcome for surgical versus non-surgical treatment for lumbar spinal stenosis: the Uppsala Spinal Stenosis Trial (UppSten). BMJ Open. 2019 Aug 20;9(8):e030578. doi: 10.1136/bmjopen-2019-030578.
PubMed 31434781
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uppsala Spinal Stenosis Study
- ClinicalTrials.gov ID
- NCT03495661
- Acronym / sponsor ID
- UppSten / u1
- Conditions
- Spinal Stenosis, Spinal Stenosis Lumbar, Degeneration Lumbar Spine, Degeneration Spine, Neurogenic Claudication Co-Occurrent and Due to Spinal Stenosis of Lumbar Region, Pseudoclaudication Syndrome
- Keywords
- lumbar spine stenosis, decompression, laminectomy, physiotherapy, physical therapy, electroneurography, ENG, electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 12 Apr 2018 (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.
Lumbar spinal stenosis (LSS) is characterized by low back and leg pain, walking disturbances and sometimes instability, impaired balance and numbness of the lower limbs. This condition is caused by degenerative changes in the lumbar spine including bulging discs, osteophytes from the arthritic facet joints and thickened ligamentum flavum which together cause narrowing of the spinal canal and thus affect the lumbar nerve roots. This diagnosis is attracting more and more interest due to the aging population with increasing demands for physical activity. LSS is the most common indication for spinal surgery. The surgical treatment involves relieving the pressure from the nerve structures in the stenotic segments through a posterior approach. In several studies, surgery has been shown to have better results than the conservative treatment. However, methodological difficulties and a large proportion of cross-over in these studies indicate that there is still uncertainty about whether surgery is generally a better option.
It has been speculated whether the compression of the nerve roots causes in some patients permanent nerve damage with muscle denervation, while in other cases a reinnervation and recovery of the function may occur. Results from neurography and EMG studies have been shown these modalities to have a possible predictive value for the natural process of LSS. If a neurophysiological examination could be able to predict which patients are able to benefit from surgery, many patients could avoid surgery and the risks involved in it.
The aim of this study is primarily to evaluate whether surgery with decompression leads to superior results than the non-surgical treatment with structured physical therapy.
The main secondary aim is to investigate by means of Neurography and EMG, whether the degree of neurological affection caused by nerve compression affects the outcome of surgery for LSS.
Detailed description
Background
Lumbar spinal stenosis (LSS) is characterized by low back and leg pain, walking disturbances and sometimes instability, impaired balance and numbness of the lower limbs. This condition is caused by degenerative changes in the lumbar spine including bulging discs, osteophytes from the arthritic facet joints and thickened ligamentum flavum which together cause narrowing of the spinal canal and thus affect the lumbar nerve roots. LSS affects mainly older populations and is unusual under 50 years old. This diagnosis is attracting more and more interest due to the aging population with increasing demands for physical activity. LSS is the most common indication for spinal surgery. The surgical treatment involves relieving the pressure from the nerve structures in the stenotic segments through a posterior approach. The hypertrophic ligaments and parts of the facet joints are removed (i.e., decompression). Adding fusion to the decompression for stabilization of the decompressed segment has not been shown to provide superior results than decompression alone. In several studies, surgery has been shown to have better results than the conservative treatment. However, methodological difficulties and a large proportion of cross-over in these studies indicate that there is still uncertainty about whether surgery is generally a better option.
After decompression, only 60-70% of patients reported to be satisfied with the result and a minor proportion of them experienced even no improvement at all [Strömqvist]. Conservative treatment has shown in some studies to have good results for some patient groups and other studies have shown that the benefit of the surgical treatment decreases over time and that physical exercise may reduce the need for surgery. Moreover, surgery itself has a positive placebo effect that can improve symptoms in some diseases.
It has been speculated whether the compression of the nerve roots causes in some patients permanent nerve damage with muscle denervation, while in other cases a reinnervation and recovery of the function may occur. Results from neurography and EMG studies have been shown these modalities to have a possible predictive value for the natural process of LSS. If a neurophysiological examination could be able to predict which patients are able to benefit from surgery, many patients could avoid surgery and the risks involved in it.
The degeneration of the lumbar spine is progressively impairing the spinal sagittal balance. The need to make extensive correction and fusion in addition to the decompression in order to restore the sagittal balance is debated among spinal surgeons. The experience gained from previous RCTs is that the patients' back pain is reduced by decompression only. Many patients also report that their posture improved after decompression alone.
Previous trials in the connective tissue and blood samples have shown that proinflammatory factors and nociceptors (molecules that induce pain) are upregulated in patients with patellar tendinosis which is an inflammatory condition. Changes in the connective tissue that cause LSS are mainly inflammatory (arthritic facet joints and ligamentum flavum) and a possible theory around LSS pathophysiology may be that the nerves are biologically affected by proinflammatory factors and nociceptors. Identification of some of these factors could lead to better explanation of the pathomechanism behind the nerve compression in LSS and to the development of future pharmacological treatments to be used in conjunction with surgery.
Aims
The aim of this study is primarily to evaluate whether surgery with decompression leads to superior results than the non-surgical treatment with structured physical therapy. For this evaluation, the Oswestry Disability Index (ODI) will be used.
The main secondary aim is to investigate by means of Neurography and EMG, whether the degree of neurological affection caused by nerve compression affects the outcome of surgery for LSS.
Aims The aim of this study is primarily to evaluate whether surgery with decompression leads to superior results than the non-surgical treatment with structured physical therapy. For his evaluation, the Oswestry Disability Index (ODI) will be used.
The main secondary aim is to investigate by means of Neurography and EMG, whether the degree of neurological affection caused by nerve compression affects the outcome of surgery for LSS.
The questions at issue are:
- Does decompression provide a better clinical outcome than the non-surgical treatment?
- Is there any correlation between the clinical grade of symptoms and the degree of neurological affection measured by ENG/EMG?
- Is there any connection between the neurological affection and the proinflammatory markers/nociceptors in the blood as well as in histological findings from ligamentum flavum? Are these correlated with the clinical grade of symptoms?
- Does decompression provide superior neurological recovery, measured by ENG/EMG, in comparison to the non-surgical treatment ?
- Can decompression improve the spinal sagittal balance?
Follow-up 6 months, 1, 2 and 5 years
The results at 2 years will be the most important goal of the study, on which the main clinical results will be built. The neurophysiological results can be analyzed and presented after the 6-month follow up.
Flow-chart
Recruitment The patient is recruited during an outpatient visit to a surgeon. Oral and written information about the study is given.
ICF The patient gives oral and written consent. The consent is documented in the patient journal and the written consent is filed in the study document binder.
Baseline data - PROMs via Swespine Study
- 6MWT
- Scoliosis standing digital X-rays (AP and lateral views)
- ENG/EMG
- Blood samples for analysis of inflammatory markers (OLINK)
Randomizing Simple block randomization to the two treatment arms.
Treatment arms A. Decompression. Central decompression of the stenotic segments with undercutting of the lateral recesses, free mobilization, and routine follow-up postoperatively by physiotherapist.
- Non-surgical treatment. Exercise on exercise bike according to the "Östersund model" [Nord] 30 min, 3 times/week for 4 months.
Follow-up 6 months - PROMs via Swespine Study
- 6MWT
- Scoliosis standing digital X-rays (AP and lateral views)
- ENG/EMG
- Blood samples for analysis of inflammatory markers (OLINK)
Cross-over Feasibility for cross-over from group B till A after 6-month follow-up.
Follow-up 1,2 years - PROMs via Swespine Study
- 6MWT
Follow -up 5 years - PROMs via Swespine Study
In the treatment group A, in conjunction with the surgical procedure, ligamentum flavum will be collected (which is usually removed during the decompression surgery) and will be examined with histological methods regarding proinflammatory markers and nociceptors . An 1x1 cm tissue piece will be dissected and saved. The ligament samples will be examined by immunohistochemistry and with proteomics analysis. Proteomics analysis will be performed in collaboration with Olink Uppsala (www.olink.com) where 92 inflammation-related factors will be investigated. Sample management will be in accordance with the Ethics Examination Act of Human Research (2003: 460) and according to the rules of Uppsala Biobank.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- prospective clinical randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Surgical (Decompression) | Active comparator | Procedure: DecompressionCentral decompression of the stenotic segment(s) with undercutting of the lateral recesses. |
| Non-surgical | No intervention | –Physical therapy according to the "Östersund model": training on stationary bicycle 30 min, 3 times/week under 4 months. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50-85 years.
- Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) that indicate and motivate surgery. NRS in lower limbs ≥3.
- MRI with finding of LSS at 1-3 lumbar levels. Dural sac area ≤ 75 mm² or degree of stenosis C or D according to Schizas classification.
- The surgical treatment to be provided is decompression alone.
- The patient has given oral and written informed consent to the participation in the study.
Key exclusion criteria (9 listed)
- Degenerative deformity with Cobb angle > 20°.
- Spondylolysis.
- Symptomatic osteoarthritis in the lower limbs that affects and limits their function.
- Arterial insufficiency (claudication intermittent) .
- Past lumbar surgery other than disc hernia.
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 |
|---|---|---|
| DecompressionAlso: LaminectomyCentral decompression of the stenotic segment(s) with undercutting of the lateral recesses. | Procedure or surgery | Surgical (Decompression) |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: Baseline
Through the Swedish National Spine Registry (SweSpine)
Oswestry Disability Index (ODI)
Time frame: 6 months
Through the Swedish National Spine Registry (SweSpine)
Oswestry Disability Index (ODI)
Time frame: 1 year
Through the Swedish National Spine Registry (SweSpine)
Oswestry Disability Index (ODI)
Time frame: 2 years
Through the Swedish National Spine Registry (SweSpine)
Oswestry Disability Index (ODI)
Time frame: 5 years
Through the Swedish National Spine Registry (SweSpine)
13 secondary outcomes
Motor Amplitude (ENG)
Time frame: Baseline and 6 months postoperatively
Denervation Activity (EMG)
Time frame: Baseline and 6 months follow-up
Sensory Amplitude (ENG)
Time frame: Baseline and 6 months follow-up
Late Responses (F-wave and H.Reflex)
Time frame: Baseline and 6 months follow-up
Motor Unit Number Index (MUNIX)
Time frame: Baseline and 6 months follow-up
Grade of Reinnervation (EMG)
Time frame: Baseline and 6 months follow-up
EQ-5D
Time frame: Baseline and 6 months, 1, 2, 5 years follow-up
NRS for Low Back and Leg Pain
Time frame: Baseline and 6 months, 1, 2, 5 years follow-up
Subjective Walking Ability
Time frame: Baseline and 6 months, 1, 2, 5 years follow-up
Global Assessment (GA)
Time frame: Baseline and 6 months, 1, 2, 5 years follow-up
Patient Satisfaction
Time frame: Baseline and 6 months, 1, 2, 5 years follow-up
Objective Walking Ability
Time frame: Baseline and 6 months, 1, 2 years follow-up
Lumbar Lordosis (LL) and Sagittal Vertebral Axis (SVA)
Time frame: Baseline and 6 months follow-up
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 16 Dec 2021.
- Derived from this study: PubMed 31434781Pazarlis K, Punga A, Schizas N, Sanden B, Michaelsson K, Forsth P. Study protocol for a randomised controlled trial with clinical, neurophysiological, laboratory and radiological outcome for surgical versus non-surgical treatment for lumbar spinal stenosis: the Uppsala Spinal Stenosis Trial (UppSten). BMJ Open. 2019 Aug 20;9(8):e030578. doi: 10.1136/bmjopen-2019-030578.
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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.
Konstantinos Pazarlis, MD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decompression in people with Spinal Stenosis and Spinal Stenosis Lumbar, run by Uppsala University at 1 site in Sweden.
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 9 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 Dec 2021. 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 Sweden. 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 (ODI) (time frame: Baseline). The study lists 5 primary outcomes in all. 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 NCT03495661, 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 16 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.