Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis

Официальное название

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

Обзор

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.

Вмешательства

• Процедура surgery
  standard decompression surgery
• Поведенческое 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.

Первичные конечные точки

• The proportion (%) of patients who improve 30% or more relative to baseline in Oswestry Disability Index 2.1 (ODI) [Срок оценки: 6 months after index treatment]

Вторичные конечные точки (12)

• Patient reported leg pain by Numeric Rating Scale (NRS) [Срок оценки: Baseline and 6 months]
• Patient reported leg pain by Numeric Rating Scale (NRS) [Срок оценки: Baseline and 1 year]
• Patient reported leg pain by Numeric Rating Scale (NRS) [Срок оценки: Baseline and 2 years]
• Patient reported back pain by Numeric Rating Scale (NRS) [Срок оценки: Baseline and 6 months]
• Patient reported back pain by Numeric Rating Scale (NRS) [Срок оценки: Baseline and 1 year]
• Patient reported back pain by Numeric Rating Scale (NRS) [Срок оценки: Baseline and 2 years]
• Walking capacity measured by six-minutes walk-test [Срок оценки: Baseline and 6 months]
• Improvement in health-related quality of life [Срок оценки: Baseline and 1 year, and 2 years after index treatment]
• Improvement in health-related quality of life [Срок оценки: Baseline and 2 years]
• Fraction of patients crossing over from physical therapy to surgical decompression [Срок оценки: 6 months]
• Fraction of patients crossing over from physical therapy to surgical decompression [Срок оценки: 1 year]
• Improvement of walking and standing capacity measured with accelerometer [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Норвегия · 3 центра

• Innlandet Hospital Trust — Lillehammer
• Martina Hansen's Hospital — Oslo
• St Olavs Hospital — Trondheim

Идентификаторы

NCT: NCT04552145 · 2019/283

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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