Clinical trial NCT03388983: Effectiveness of Prehabilitation for Patients Undergoing Lumbar Spinal Stenosis Surgery
Official title: The Effectiveness of Prehabilitation for Patients Undergoing Lumbar Spinal Stenosis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spinal Stenosis
Prehabilitation
Keywords: Prehabilitation
Physical activity
Lumbar decompression surgery
Randomized controlled trial
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Université du Québec à Trois-Rivières
name: The University of Hong Kong
First posted: 2018-01-03
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blinded randomized controlled trial
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Chinese/English Version Oswestry Disability Index (ODI)
timeFrame: 6 months
Secondary outcomes:
measure: Pain medication
timeFrame: 6 months
measure: Duration of hospital stay
timeFrame: 6 months
measure: 11-point numeric pain rating scale (NPRS) for measuring back/leg pain
timeFrame: 6 months
measure: Physical activity monitoring
timeFrame: 6 months
measure: The Chinese version of EuroQol-5D-3L for measuring quality of life
timeFrame: 6 months
measure: Swiss Spinal Stenosis Questionnaire
timeFrame: 6 months
measure: International Physical Activity Questionnaire
timeFrame: 6 months
measure: Clinical Global Impression of Change
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Arnold Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: