Spinal StenosisPTvsSDNCT04552145
Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis
A study testing surgery and Physiotherapy in people with Spinal Stenosis, run by Norwegian University of Science and Technology at 3 sites in Norway.
Trial summary
This is a randomized controlled multicenter trail comparing physical therapy to surgical decompression in patients with lumbar spinal stenosis. The 0-hypothesis is that there is no difference in the efficacy of structured physical therapy compared to surgical decompression. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- surgery and Physiotherapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 3 sitesNorway
- Study dates
- 1 Sep 2020to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients describing intermittent neurogenic claudication when walking and symptoms revealed by flexion of the spine.
- MRI shows lumbar spinal stenosis in one or two levels measured.
- The duration of the symptoms is longer than six months
- The patient is a candidate for surgical treatment
- The patient is capable of physical exercise
Who cannot join
- Vascular intermittent claudication
- Lumbar spinal stenosis in more than two levels
- Previous low back surgery
- Symptomatic lumbar disc herniation
- Degenerative scoliosis with Cobbs angle 30 degrees or more
- Degenerative spondylolisthesis grade 2 or more
Show all 13Show fewer
- Spondylolysis with spondylolisthesis
- Recent osteoporotic fractures in the spine (last 6 month)
- Severe symptomatic arthrosis in hip or knee
- Locally advanced or metastatic cancer
- ASA >3
- Polyneuropathy recognized by neurography
- Insufficient Norwegian language skills
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rønnaug Sulheim, pt contact
Norway3 sites, 3 recruiting
- Recruiting
Innlandet Hospital Trust
Lillehammer
Greger Lønne, md phd, gloenne@me.com
- Recruiting
Martina Hansen's Hospital
Oslo
Elisabeth Thornes, md
Nikolaos Ikonomo, md
- Recruiting
St Olavs Hospital
Trondheim
Sasha Gulati, md phd
Hege Andresen
About this study
Official title: Physical Therapy Versus Surgical Decompression for Lumbar Spinal Stenosis: A Multicenter Randomized Controlled Trial
This is a randomized controlled multicenter trail comparing physical therapy to surgical decompression in patients with lumbar spinal stenosis. The 0-hypothesis is that there is no difference in the efficacy of structured physical therapy compared to surgical decompression.
Our aim is to evaluate if physical therapy can serve as a nonsurgical alternative for patients with LSS, where the severity of symptoms indicates the need of surgical decompression.
- Conditions
- Spinal Stenosis
- Being tested
- surgery, Physiotherapy
- Keywords
- Surgery, Physical Therapy Modalities
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
standard decompression surgery
PhysiotherapyBehavioural
3 month physical therapy treatment including home activity based on a well defined program and 4 to 6 visits at physical therapy intervention center.
| Study group | Role | What they receive |
|---|---|---|
| surgery | Active comparator | Decompression surgery Receives: Procedure: surgery |
| physiotherapy | Active comparator | Physical therapy program Receives: Behavioral: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
Oswestry Disability Index 2.0 (ODI) is the most commonly used condition-specific outcome measure for spinal disorders in general. The score ranges from 0 to 100, with a lower score indicating less severe pain and disability. It has been validated into Norwegian and tested for psychometric properties.
Measured: 6 months after index treatment
Secondary outcomes (15)
Patient reported leg pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Measured: Baseline and 6 months
Patient reported leg pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Measured: Baseline and 1 year
Patient reported leg pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Measured: Baseline and 2 years
Patient reported back pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Measured: Baseline and 6 months
Patient reported back pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Measured: Baseline and 1 year
Patient reported back pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Measured: Baseline and 2 years
Walking capacity measured by six-minutes walk-test
Number of patients improving by 50 m or more after six-minutes walk-test
Measured: Baseline and 6 months
Improvement in health-related quality of life
Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index
Measured: Baseline and 1 year, and 2 years after index treatment
Improvement in health-related quality of life
Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index
Measured: Baseline and 2 years
Fraction of patients crossing over from physical therapy to surgical decompression
We will give the possibility to cross over to surgery 6 months, 1 year, and 2 years after index treatment
Measured: 6 months
Fraction of patients crossing over from physical therapy to surgical decompression
We will give the possibility to cross over to surgery 6 months, 1 year, and 2 years after index treatment
Measured: 1 year
Improvement of walking and standing capacity measured with accelerometer
We will use a body-worn tri-axial lightweight accelerometer (AX3 sensor from Axivity, York, UK) attached by a waterproof tape to the midpoint of the patients' anterior right thigh and at the lower back.
Daily physical activity such as walking, running, standing, sitting, lying down and cycling will be monitored. By comparing the continuous activity for one week before treatment, for one week at six-, and 12-month follow-up, we will be able to objectively report about changes in the activity level (25). Since LSS-patients have symptoms while walking and standing, we will report the activity as ratios of walking/standing compare to other activity, as well as summon the three longest walking/standing periods before and after treatment.
Measured: Baseline and 6 months
Improvement of walking and standing capacity measured with accelerometer
We will use a body-worn tri-axial lightweight accelerometer (AX3 sensor from Axivity, York, UK) attached by a waterproof tape to the midpoint of the patients' anterior right thigh and at the lower back.
Daily physical activity such as walking, running, standing, sitting, lying down and cycling will be monitored. By comparing the continuous activity for one week before treatment, for one week at six-, and 12-month follow-up, we will be able to objectively report about changes in the activity level (25). Since LSS-patients have symptoms while walking and standing, we will report the activity as ratios of walking/standing compare to other activity, as well as summon the three longest walking/standing periods before and after treatment.
Measured: Baseline and 1 year
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
The ODI score ranges from 0 to 100, with a lower score indicating less severe pain and disability.
Measured: 1 year after index treatment
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
The ODI score ranges from 0 to 100, with a lower score indicating less severe pain and disability.
Measured: 2 years after index treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Sep 2020
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Randomised controlled multicenter study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Sykehuset Innlandet HF, Vestre Viken Hospital Trust
- Responsible party
- Sponsor
- Investigators
- Greger Lønne, md phd, Principal investigator, Norwegian University of Science and Technology, Fac MH, INBJorunn L Helbostad, phd prof, Study director, Norwegian University of Science and Technology, Fac MH, INB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552145
- Sponsor's protocol ID
- 2019/283
- Acronym
- PTvsSD
- Status last verified
- Jun 2025
- First submitted
- 10 Sep 2020
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy Versus Surgical Decompression for Lumbar Spinal Stenosis: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04552145
- Acronym / sponsor ID
- PTvsSD / 2019/283
- Conditions
- Spinal Stenosis
- Keywords
- Surgery, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Sykehuset Innlandet HF, Vestre Viken Hospital Trust
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 Sep 2020 (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.
This is a randomized controlled multicenter trail comparing physical therapy to surgical decompression in patients with lumbar spinal stenosis. The 0-hypothesis is that there is no difference in the efficacy of structured physical therapy compared to surgical decompression.
Our aim is to evaluate if physical therapy can serve as a nonsurgical alternative for patients with LSS, where the severity of symptoms indicates the need of surgical decompression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled multicenter study
| Arm | Type | Receives |
|---|---|---|
| surgery | Active comparator | Procedure: surgeryDecompression surgery |
| physiotherapy | Active comparator | Behavioral: PhysiotherapyPhysical therapy program |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients describing intermittent neurogenic claudication when walking and symptoms revealed by flexion of the spine.
- MRI shows lumbar spinal stenosis in one or two levels measured.
- The duration of the symptoms is longer than six months
- The patient is a candidate for surgical treatment
- The patient is capable of physical exercise
Key exclusion criteria (13 listed)
- Vascular intermittent claudication
- Lumbar spinal stenosis in more than two levels
- Previous low back surgery
- Symptomatic lumbar disc herniation
- Degenerative scoliosis with Cobbs angle 30 degrees or more
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 |
|---|---|---|
| surgerystandard decompression surgery | Procedure or surgery | surgery |
| Physiotherapy3 month physical therapy treatment including home activity based on a well defined program and 4 to 6 visits at physical therapy intervention center. | Behavioural | physiotherapy |
Primary outcome
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
Time frame: 6 months after index treatment
Oswestry Disability Index 2.0 (ODI) is the most commonly used condition-specific outcome measure for spinal disorders in general. The score ranges from 0 to 100, with a lower score indicating less severe pain and disability. It has been validated into Norwegian and tested for psychometric properties.
15 secondary outcomes
Patient reported leg pain by Numeric Rating Scale (NRS)
Time frame: Baseline and 6 months
Patient reported leg pain by Numeric Rating Scale (NRS)
Time frame: Baseline and 1 year
Patient reported leg pain by Numeric Rating Scale (NRS)
Time frame: Baseline and 2 years
Patient reported back pain by Numeric Rating Scale (NRS)
Time frame: Baseline and 6 months
Patient reported back pain by Numeric Rating Scale (NRS)
Time frame: Baseline and 1 year
Patient reported back pain by Numeric Rating Scale (NRS)
Time frame: Baseline and 2 years
Walking capacity measured by six-minutes walk-test
Time frame: Baseline and 6 months
Improvement in health-related quality of life
Time frame: Baseline and 1 year, and 2 years after index treatment
Improvement in health-related quality of life
Time frame: Baseline and 2 years
Fraction of patients crossing over from physical therapy to surgical decompression
Time frame: 6 months
Fraction of patients crossing over from physical therapy to surgical decompression
Time frame: 1 year
Improvement of walking and standing capacity measured with accelerometer
Time frame: Baseline and 6 months
Improvement of walking and standing capacity measured with accelerometer
Time frame: Baseline and 1 year
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
Time frame: 1 year after index treatment
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
Time frame: 2 years after index treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Rønnaug Sulheim, pt contact
Greger Lønne, md phd principal investigator
Norwegian University of Science and Technology, Fac MH, INB
Jorunn L Helbostad, phd prof study director
Norwegian University of Science and Technology, Fac MH, INB
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery and Physiotherapy in people with Spinal Stenosis, run by Norwegian University of Science and Technology at 3 sites in Norway.
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 13 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greger Lønne, md phd (+4797114107, gloenne@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI) (time frame: 6 months after index treatment). 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 22 Jun 2025.