The Effectiveness of Prehabilitation for Patients Undergoing Lumbar Spinal Stenosis: A Randomized Clinical Trial

The Hong Kong Polytechnic University1 site in 1 country120 target enrollmentAugust 10, 2018

Overview

Brief Summary

Lumbar spinal stenosis (LSS) is a common spinal disease that leads to pain and disability. LSS is defined as lower extremity and perineal symptoms (e.g. intermittent neurogenic claudication/numbness) that may occur with or without low back pain and that is attributed to congenital or acquired narrowing of space available for the neural and vascular tissues in the lumbar spine. Patients with LSS,who do not respond to conservative treatments after 3 months or more, will be eligible for spinal decompression surgery in order to improve functional outcomes.

While various studies have shown that preoperative exercises (prehabilitation) may benefit patients receiving different surgeries (e.g, abdominal surgery, anterior cruciate ligament reconstruction), little is known regarding the effect of prehabilitation for patients undergoing LSS surgery.

The aim of the current randomized controlled trial is to compare the effectiveness of a 6-week prehabilitation program with usual preoperative care in improving multiple outcomes of patients undergoing LSS surgery at baseline, 6 weeks after baseline evaluation, and at 3 and 6 months postoperatively. It is hypothesized that prehabilitation will yield significantly better pre- and post-operative clinical outcomes as compared to usual preoperative care.

Detailed Description

Lumbar spinal stenosis (LSS) is a common spinal disease that leads to pain and disability. LSS is defined as lower extremity and perineal symptoms (e.g. intermittent neurogenic claudication/numbness) that may occur with or without low back pain and that is attributed to congenital or acquired narrowing of space available for the neural and vascular tissues in the lumbar spine. Clinical symptoms of LSS include pain, numbness, weakness and warmth in bilateral/unilateral buttock or legs that is precipitated by walking or prolonged standing but is alleviated by sitting or forward bending. Acquired (degenerative) LSS is the most common degenerative conditions that leads to spinal surgery in adults aged 65 years or older.\[2\] It is known that the occurrence of degenerative LSS increases with age. Given the aging of the global population (including Hong Kong), the prevalence of degenerative LSS is expected to increase. Major causes of degenerative LSS in older adults are the compression and/or ischemia of nerve roots in diminished lateral or central spinal canals secondary to lumbar spondylosis, progressive hypertrophy of ligamentous/osteocartilaginous structures, or degenerative spondylolisthesis. When patients fail to improve after conservative treatments, surgical intervention is recommended for symptomatic LSS. While decompressive laminectomy/laminotomy with or without spinal fusion for LSS has shown significantly less leg symptoms than conservative treatments, up to 40% of patients undergoing LSS surgery were unsatisfied with the postoperative neurogenic claudication and/or radicular leg symptoms. Accordingly, evidence-based management is needed for patients undergoing LSS surgery to optimize patients' recovery. Various studies have shown that preoperative exercises (prehabilitation) may benefit patients receiving different surgeries (e.g, abdominal surgery, anterior cruciate ligament reconstruction). Although there is a paucity of prehabilitation for patients undergoing LSS surgery. the potential benefits of prehabilitation substantiate the investigation of prehabilitation for patients undergoing LSS surgery. Given the above, the aim of the current randomized controlled trial is to compare the effectiveness of a 6-week prehabilitation program with usual preoperative care in improving multiple outcomes of patients undergoing LSS surgery at baseline, 6 weeks after baseline evaluation, and at 3 and 6 months postoperatively. It is hypothesized that prehabilitation will yield significantly better pre- and post-operative clinical outcomes as compared to usual preoperative care.

Registry

clinicaltrials.gov

Start Date

August 10, 2018

End Date

June 30, 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Hong Kong Polytechnic University

Responsible Party

Principal Investigator

Dr Arnold Wong Yu Lok

Assistant Professor

The Hong Kong Polytechnic University

Eligibility Criteria

Inclusion Criteria

•signs of neurogenic claudication
•radiological signs of degenerative LSS on magnetic resonance images or computed tomography images
•radiculopathy with or without low back pain for more than 3 months that is unresponsive to conservative intervention
•Oswestry Disability Index (ODI) \> 30 out of 100
•patients undergoing open or minimally invasive laminotomy/laminectomy
•willing to complete pre- and post-operative questionnaires and physical assessments at prescheduled time points

Exclusion Criteria

•inability to read, speak and understand English/Chinese
•inability to give informed consent
•surgical management for lumbar fractures, tumors, synovial cysts, and scoliosis correction
•any revision lumbar spine surgery, (5) diagnosis of chronic pain conditions (e.g. fibromyalgia)
•presence of a neurological or systematic neuromuscular diseases (e.g. multiple sclerosis, stroke, or rheumatoid arthritis)
•planning for spinal fusion
•discogenic nerve compression or instability (flexion-extension X-ray film shows \> 5mm of sagittal-plane translation)

Outcomes

Primary Outcomes

Chinese/English Version Oswestry Disability Index (ODI)

Time Frame: 6 months

The ODI comprises 10 questions covering areas related to: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, sexual life and traveling.