Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis (PTvsSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04552145
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborators:
St. Olavs Hospital
Sykehuset Innlandet HF
Martina Hansen's Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Spinal Stenosis Procedure: surgery Behavioral: Physiotherapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Therapy Versus Surgical Decompression for Lumbar Spinal Stenosis: A Multicenter Randomized Controlled Trial
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: surgery
Decompression surgery
Procedure: surgery
standard decompression surgery

Active Comparator: physiotherapy
Physical therapy program
Behavioral: Physiotherapy
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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552145


Contacts
Layout table for location contacts
Contact: Greger Lønne, md phd +4797114107 gloenne@me.com
Contact: Rønnaug Sulheim, pt ronnaug.oleanne.sulheim@sykehuset-innlandet.no

Locations
Layout table for location information
Norway
Innlandet Hospital Trust Recruiting
Lillehammer, Norway
Contact: Greger Lønne, md phd       gloenne@me.com   
Martina Hansen's Hospital Recruiting
Oslo, Norway
Contact: Elisabeth Thornes, md         
Contact: Nikolaos Ikonomo, md         
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Sasha Gulati, md phd         
Contact: Hege Andresen         
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Sykehuset Innlandet HF
Martina Hansen's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Greger Lønne, md phd Norwegian University of Science and Technology, Fac MH, INB
Study Director: Jorunn L Helbostad, phd prof Norwegian University of Science and Technology, Fac MH, INB
Layout table for additonal information
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT04552145    
Other Study ID Numbers: 2019/283
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Surgery
Physical Therapy Modalities
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases