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

Norwegian University of Science and Technology

Status: Enrolling

Conditions: Spinal Stenosis

Treatments: Procedure: surgery; Behavioral: Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04552145

2019/283

Details and patient eligibility

About

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.

Enrollment: 232 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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232 participants in 2 patient groups

surgery

Active Comparator group

Description:

Decompression surgery

Treatment:

Procedure: surgery

physiotherapy

Active Comparator group

Description:

Physical therapy program

Treatment:

Behavioral: Physiotherapy