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

Primary Purpose

Spinal Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
surgery
Physiotherapy
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis focused on measuring Surgery, Physical Therapy Modalities

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Innlandet Hospital TrustRecruiting
  • Martina Hansen's HospitalRecruiting
  • St Olavs HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

surgery

physiotherapy

Arm Description

Decompression surgery

Physical therapy program

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient reported leg pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Patient reported leg pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Patient reported leg pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Patient reported back pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Patient reported back pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Patient reported back pain by Numeric Rating Scale (NRS)
NRS, scores 0-10, where a higher score indicates more pain
Walking capacity measured by six-minutes walk-test
Number of patients improving by 50 m or more after six-minutes walk-test
Improvement in health-related quality of life
Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index
Improvement in health-related quality of life
Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index
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
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
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.
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.
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.
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.

Full Information

First Posted
September 10, 2020
Last Updated
September 16, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Sykehuset Innlandet HF, Martina Hansen's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04552145
Brief Title
Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis
Acronym
PTvsSD
Official Title
Physical Therapy Versus Surgical Decompression for Lumbar Spinal Stenosis: A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Sykehuset Innlandet HF, Martina Hansen's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
Keywords
Surgery, Physical Therapy Modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgery
Arm Type
Active Comparator
Arm Description
Decompression surgery
Arm Title
physiotherapy
Arm Type
Active Comparator
Arm Description
Physical therapy program
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
standard decompression surgery
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Intervention Description
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 Measure Information:
Title
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
Description
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.
Time Frame
6 months after index treatment
Secondary Outcome Measure Information:
Title
Patient reported leg pain by Numeric Rating Scale (NRS)
Description
NRS, scores 0-10, where a higher score indicates more pain
Time Frame
Baseline and 6 months
Title
Patient reported leg pain by Numeric Rating Scale (NRS)
Description
NRS, scores 0-10, where a higher score indicates more pain
Time Frame
Baseline and 1 year
Title
Patient reported leg pain by Numeric Rating Scale (NRS)
Description
NRS, scores 0-10, where a higher score indicates more pain
Time Frame
Baseline and 2 years
Title
Patient reported back pain by Numeric Rating Scale (NRS)
Description
NRS, scores 0-10, where a higher score indicates more pain
Time Frame
Baseline and 6 months
Title
Patient reported back pain by Numeric Rating Scale (NRS)
Description
NRS, scores 0-10, where a higher score indicates more pain
Time Frame
Baseline and 1 year
Title
Patient reported back pain by Numeric Rating Scale (NRS)
Description
NRS, scores 0-10, where a higher score indicates more pain
Time Frame
Baseline and 2 years
Title
Walking capacity measured by six-minutes walk-test
Description
Number of patients improving by 50 m or more after six-minutes walk-test
Time Frame
Baseline and 6 months
Title
Improvement in health-related quality of life
Description
Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index
Time Frame
Baseline and 1 year, and 2 years after index treatment
Title
Improvement in health-related quality of life
Description
Measured by EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L) utility index
Time Frame
Baseline and 2 years
Title
Fraction of patients crossing over from physical therapy to surgical decompression
Description
We will give the possibility to cross over to surgery 6 months, 1 year, and 2 years after index treatment
Time Frame
6 months
Title
Fraction of patients crossing over from physical therapy to surgical decompression
Description
We will give the possibility to cross over to surgery 6 months, 1 year, and 2 years after index treatment
Time Frame
1 year
Title
Improvement of walking and standing capacity measured with accelerometer
Description
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.
Time Frame
Baseline and 6 months
Title
Improvement of walking and standing capacity measured with accelerometer
Description
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.
Time Frame
Baseline and 1 year
Title
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
Description
The ODI score ranges from 0 to 100, with a lower score indicating less severe pain and disability.
Time Frame
1 year after index treatment
Title
The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI)
Description
The ODI score ranges from 0 to 100, with a lower score indicating less severe pain and disability.
Time Frame
2 years after index treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Greger Lønne, md phd
Phone
+4797114107
Email
gloenne@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rønnaug Sulheim, pt
Email
ronnaug.oleanne.sulheim@sykehuset-innlandet.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greger Lønne, md phd
Organizational Affiliation
Norwegian University of Science and Technology, Fac MH, INB
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorunn L Helbostad, phd prof
Organizational Affiliation
Norwegian University of Science and Technology, Fac MH, INB
Official's Role
Study Director
Facility Information:
Facility Name
Innlandet Hospital Trust
City
Lillehammer
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Greger Lønne, md phd
Email
gloenne@me.com
Facility Name
Martina Hansen's Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Thornes, md
First Name & Middle Initial & Last Name & Degree
Nikolaos Ikonomo, md
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasha Gulati, md phd
First Name & Middle Initial & Last Name & Degree
Hege Andresen

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis

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