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Effectiveness of Prehabilitation for Patients Undergoing Lumbar Spinal Stenosis Surgery

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ClinicalTrials.gov Identifier: NCT03388983
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborators:
Université du Québec à Trois-Rivières
The University of Hong Kong
Information provided by (Responsible Party):
Dr Arnold Wong Yu Lok, The Hong Kong Polytechnic University

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.


Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Prehabilitation Other: 6-week prehabilitation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A single-blinded randomized controlled trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: The orthopedic surgeons, outcome assessor and statistician will be blinded to the group allocation of participants.
Primary Purpose: Treatment
Official Title: The Effectiveness of Prehabilitation for Patients Undergoing Lumbar Spinal Stenosis: A Randomized Clinical Trial
Estimated Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 6-week prehabilitation group
6-week prehabilitation
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.
No Intervention: Control group
Patients will receive standard preoperative care (including information about the surgery from an orthopedic surgeon, and a pamphlet summarizing tips of maintaining proper posture and staying active). The usual postoperative care does not include routine rehabilitation program though a short course of rehabilitation may be given based on orthopedic surgeons' discretion.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain medication [ Time Frame: 6 months ]
    Dosage of pain medication taken by the participant each day will be recorded.

  2. Duration of hospital stay [ Time Frame: 6 months ]
    The length of hospital stay will be documented

  3. 11-point numeric pain rating scale (NPRS) for measuring back/leg pain [ Time Frame: 6 months ]
    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.

  4. Physical activity monitoring [ Time Frame: 6 months ]
    An ActiGraph sensor will be used to quantify physical activity level of patients before and after surgery at different time points.

  5. The Chinese version of EuroQol-5D-3L for measuring quality of life [ Time Frame: 6 months ]
    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. Swiss Spinal Stenosis Questionnaire [ Time Frame: 6 months ]
    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.

  7. International Physical Activity Questionnaire [ Time Frame: 6 months ]
    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.

  8. Clinical Global Impression of Change [ Time Frame: 6 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388983


Contacts
Contact: Arnold Wong, PhD +852 2766 6741 arnold.wong@polyu.edu.hk

Sponsors and Collaborators
The Hong Kong Polytechnic University
Université du Québec à Trois-Rivières
The University of Hong Kong
Investigators
Principal Investigator: Arnold Wong, PhD The Hong Kong Polytechnic University

Responsible Party: Dr Arnold Wong Yu Lok, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03388983     History of Changes
Other Study ID Numbers: HSEARS20171204001
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Arnold Wong Yu Lok, The Hong Kong Polytechnic University:
Prehabilitation
Physical activity
Lumbar decompression surgery
Randomized controlled trial

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases