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NCT Number: NCT04552145

Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis

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.

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Key information

Conditions

Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Innlandet Hospital Trust, Lillehammer, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Surgery

Procedure

standard decompression surgery

Physiotherapy

Behavioral

3 month physical therapy treatment including home activity based on a well defined program and 4 to 6 visits at physical therapy intervention center.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient reported leg pain by Numeric Rating Scale (NRS)

    Time frame: Baseline and 6 months

    NRS, scores 0-10, where a higher score indicates more pain

  2. Patient reported leg pain by Numeric Rating Scale (NRS)

    Time frame: Baseline and 1 year

    NRS, scores 0-10, where a higher score indicates more pain

  3. Patient reported leg pain by Numeric Rating Scale (NRS)

    Time frame: Baseline and 2 years

    NRS, scores 0-10, where a higher score indicates more pain

  4. Patient reported back pain by Numeric Rating Scale (NRS)

    Time frame: Baseline and 6 months

    NRS, scores 0-10, where a higher score indicates more pain

  5. Patient reported back pain by Numeric Rating Scale (NRS)

    Time frame: Baseline and 1 year

    NRS, scores 0-10, where a higher score indicates more pain

  6. Patient reported back pain by Numeric Rating Scale (NRS)

    Time frame: Baseline and 2 years

    NRS, scores 0-10, where a higher score indicates more pain

  7. Walking capacity measured by six-minutes walk-test

    Time frame: Baseline and 6 months

    Number of patients improving by 50 m or more after six-minutes walk-test

  8. Improvement in health-related quality of life

    Time frame: Baseline and 1 year, and 2 years after index treatment

    Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index

  9. Improvement in health-related quality of life

    Time frame: Baseline and 2 years

    Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index

  10. Fraction of patients crossing over from physical therapy to surgical decompression

    Time frame: 6 months

    We will give the possibility to cross over to surgery 6 months, 1 year, and 2 years after index treatment

  11. Fraction of patients crossing over from physical therapy to surgical decompression

    Time frame: 1 year

    We will give the possibility to cross over to surgery 6 months, 1 year, and 2 years after index treatment

  12. Improvement of walking and standing capacity measured with accelerometer

    Time frame: Baseline and 6 months

    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.

  13. Improvement of walking and standing capacity measured with accelerometer

    Time frame: Baseline and 1 year

    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.

  14. 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 ODI score ranges from 0 to 100, with a lower score indicating less severe pain and disability.

  15. 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

    The ODI score ranges from 0 to 100, with a lower score indicating less severe pain and disability.

Study contacts

Contact information is provided by the study sponsor or research team.

Greger Lønne, md phd

CONTACT

[email protected]

+4797114107

Rønnaug Sulheim, pt

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital
  • Sykehuset Innlandet HF
  • Vestre Viken Hospital Trust

Registry information

Official study title

Physical Therapy Versus Surgical Decompression for Lumbar Spinal Stenosis: A Multicenter Randomized Controlled Trial

Acronym: PTvsSD

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Sep 17, 2020
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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