Effectiveness of Prehabilitation for Patients Undergoing Lumbar Spinal Stenosis Surgery

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03388983
• Other study ID #: HSEARS20171204001
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2021
• Source: The Hong Kong Polytechnic University
• Contact: Arnold Wong, PhD
• Phone: +852 2766 6741
• Email: arnold.wong[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Prehabilitation
• Spinal Stenosis

Intervention

Other:
• 6-week prehabilitation
Participants will be trained at 3 sessions/week for 6 weeks before the surgery to enhance the overall muscle strength, endurance and spinal stability. A physiotherapist/physical trainer in the participating hospital will supervise the preoperative training. The 45-minute exercise regime will include warm-up and cool-down exercises, and a cardiovascular training on a stationary bicycle, stabilization exercises with emphasis on co-contraction of abdominal and back muscles, and hip raise and hip abduction exercises. The number of repetitions and sets of each exercise will be determined based on individual's ability. Each exercise will be slightly modified based on individual progress. The exercise intensity and complexity will be increased over time.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	The University of Hong Kong, Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chinese/English Version Oswestry Disability Index (ODI)	The ODI comprises 10 questions covering areas related to: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, sexual life and traveling.	6 months
Secondary	Pain medication	Dosage of pain medication taken by the participant each day will be recorded.	6 months
Secondary	Duration of hospital stay	The length of hospital stay will be documented	6 months
Secondary	11-point numeric pain rating scale (NPRS) for measuring back/leg pain	The current back/leg pain intensity of each participant will be quantified by an 11-point NPRS, where 0 means no pain and 10 means the worst imaginable pain.	6 months
Secondary	Physical activity monitoring	An ActiGraph sensor will be used to quantify physical activity level of patients before and after surgery at different time points.	6 months
Secondary	The Chinese version of EuroQol-5D-3L for measuring quality of life	The Chinese version of EuroQol-5D-3L questionnaire comprises the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The descriptive system involves 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has three levels of responses: no problems, some problems, extreme problems. The participant chooses the most appropriate statement in each domain. The EQ VAS quantifies the respondent's perceived health-related quality of life on a vertical VAS where 0 means 'worst imaginable health state', and 100 means 'best imaginable health state'.	6 months
Secondary	Swiss Spinal Stenosis Questionnaire	This self-administered questionnaire comprises 18 questions in three subscales: 6 questions in the symptom severity scale (ranging from 1 to 5), 6 questions in the physical function scale (ranging from 1 to 4), and 6 questions in the patient's satisfaction with treatment scale (ranging from 1 to 4). The result is expressed as a percentage of the maximum possible score. A higher score indicates more disability.	6 months
Secondary	International Physical Activity Questionnaire	International Physical Activity Questionnaire (Chinese short-form version) is a 9-item questionnaire aiming to monitor an individual's leisure-time physical activity, work/transport-related physical activity, and domestic/gardening physical activity over the last 7-day period. Based on the duration, frequency and intensity of the reported physical activity, a person will be classified as physically inactive, minimally active, and health-enhancing physically active.	6 months
Secondary	Clinical Global Impression of Change	The patient's perceived changes immediately after the prehabilitation will be measured by the Clinical Global Impression of Change scale, which is a 7-point numerical rating scale. The value of 1 indicates very much improved, while 7 means very much worse. It will help evaluate the effect of prehabilitation	6 months