Effectiveness of Prehabilitation for Patients Undergoing Lumbar Spinal Stenosis Surgery

NCT03388983 | Unknown

• 1 other identifier: HSEARS20171204001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis; Prehabilitation

Keywords

Prehabilitation; Physical activity; Lumbar decompression surgery; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pain medication

  6 months

• Duration of hospital stay

  6 months

• 11-point numeric pain rating scale (NPRS) for measuring back/leg pain

  6 months

• Physical activity monitoring

  6 months

• The Chinese version of EuroQol-5D-3L for measuring quality of life

  6 months

Study Arms (2)

6-week prehabilitation group

EXPERIMENTAL

6-week prehabilitation

Other: 6-week prehabilitation

Control group

NO INTERVENTION

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.

Interventions

6-week prehabilitation OTHER

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.

6-week prehabilitation group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Université du Québec à Trois-Rivières: collaborator
• The University of Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis; Motor Activity

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Arnold Wong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnold Wong, PhD

CONTACT

+852 2766 6741; arnold.wong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The orthopedic surgeons, outcome assessor and statistician will be blinded to the group allocation of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A single-blinded randomized controlled trial

Study Record Dates

• First Submitted: December 23, 2017
• First Posted: January 3, 2018
• Study Start: August 10, 2018
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)