Feasibility of Prehab for Lumbar Spinal Stenosis

Feasibility Testing of a Pre-surgical Rehabilitation (Prehab) Program for Patients With Lumbar Spinal Stenosis: a Pilot Randomized Controlled Trial

The literature has shown evidence of the effectiveness of prehabilitation programs on post-operative recovery for musculoskeletal conditions; however, evidence for prehabilitation for lumbar spinal stenosis (LSS) is limited. Investigators have found that there is very low to low quality evidence for the effect of prehabilitation interventions for improving outcomes following lumbar spine surgery. Therefore, the purpose of this study will be to determine the feasibility of a prehabilitation program for patients undergoing LSS surgery, and pilot test the protocol to provide the foundation for future design of a larger, multicenter randomized controlled trial.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis; Prehabilitation
• Intervention / Treatment: Other: Prehab for LSS; Other: Usual Care

Detailed Description

Background:

Lumbar spinal stenosis (LSS) is the most common degenerative condition among older adults, and the leading reason older adults aged 65 and older undergo surgery. LSS is characterized by degenerative changes that lead to loss of intervertebral disc spaces, joint thickening, and enfolding of the ligaments surrounding the spine. These degenerative changes may cause compression of lumbosacral nerve roots resulting in the narrowing of central and vertebral canals known as neurogenic claudication (NC). The symptoms of NC include cramping, numbness or tingling, and muscle weakness in the lower back, buttocks, or one or both legs, with symptoms often intensifying with standing and walking.

The majority of individuals undergoing surgery for LSS are post-retirement age, have chronic low back pain, without access to private rehabilitation. This population is often severely deconditioned prior to surgery with weakness and atrophy of the muscles in the back, core, and lower limb. These preoperative factors have been shown to be predictors for postoperative LSS outcomes. Studies have shown evidence of the effectiveness of prehabilitation programs on post-operative recovery for other musculoskeletal conditions such as total knee arthroplasty. However, there appears to be a lack of high-quality evidence for the effect of prehabilitation interventions in improving outcomes for LSS surgery.

Research Aims:

The purpose of this study is to determine the feasibility of the program of care on a group of patients with LSS undergoing surgery, and determine the feasibility of the protocol for a randomized controlled trial.

Methods:

This mixed methods study will include a two-armed, pilot RCT evaluating an 8-week virtual prehabilitation program for participants undergoing LSS surgery, with a longitudinal qualitative study conducted parallel to the pilot RCT. The two groups in the RCT study will be: 1) prehabilitation, and 2) usual care.

Recruitment:

There will be 60 participants recruited from participating spine surgeons in 3 Canadian cities - Hamilton, Edmonton, and Calgary. Participants will be included if 1) they are a minimum 20 weeks prior to their date of surgery, 2) older than 55 years of age, 3) are scheduled for first spine surgery , and 4) are English-speaking. Participants will be excluded if 1) they have a known or suspected pathology (e.g., cancer, cauda equina syndrome), 2) are unable to engage in exercise due to other comorbidities or cognitive issues, and 3) if they do not have access to the Internet.

Interventions:

The 8-week prehabilitation program will be delivered online using synchronous and asynchronous sessions delivered by either a physiotherapist, chiropractor or kinesiologist, with a booster session at 6-weeks post-op. There will be 4 individual exercises sessions (week 1, 2, 4 and 8) delivered synchronously using Zoom or Physitrack in which motivational interviewing and graded activity exercises will be conducted. Participants will also be asked to exercise at least 3 times a week using the asynchronous exercise videos. Participants will receive short online educational videos (3-5 minutes). Educational sessions will include information regarding the importance of exercise, pain education, self-management, exercising despite pain, post-operative expectations, and information regarding their upcoming surgery. The educational sessions will also include two online peer-support groups when they can interact with a patient with a history of LSS surgery.

Participants in the control group will receive usual care for LSS surgery, which will consist of one session with an anesthesiologist, a nurse and access to our online educational videos.

Outcomes:

Outcomes will be evaluated at: baseline (~20 weeks before LSS surgery), immediately after the intervention (8-weeks), 3 and 12 months post-operatively. Feasibility outcomes are: 1) recruitment rate; 2) patient adherence to the program and attrition rates; 3) acceptability of program content; and 4); acceptability of study procedures and completion of study questionnaires. Patient reported outcomes will be used to inform feasibility, study burden and sample size calculations. These outcomes include: pain and disability, health-related quality of life, psychological measures, and monitoring variables. Ecological Momentary Assessments using activity monitors will be used to evaluate walking ability and daily pain.

Qualitative Methods A longitudinal qualitative study will be conducted parallel to the pilot RCT. We will use purposive sampling to conduct in-depth semi structured interviews at baseline (~20 weeks before LSS surgery), 8-weeks after the intervention, 3 months, and 12 months post-operatively. For the qualitative study, we will aim to recruit 12-15 participants or until saturation is met. The longitudinal qualitative study will assess the barriers and facilitators that influence engagement in prehabilitation, as well as the changes in pain and health that occur over time and how these are related to the program, personal (e.g., sex and gender, age, comorbid health, pain profile) or contextual factors (psychosocial, environmental, health systems).

Analysis:

All analyses will be conducted using STATA 15. Descriptive statistics will be used to report feasibility outcomes, as well as to identify trends in patient-reported outcomes. Qualitative interviews will be analyzed using interpretive phenomenological analysis (IPA) informed by the Consolidated Criteria for Reporting Qualitative Studies. Inductive thematic analysis will be used to analyze the data and report the study findings.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Edmonton, Canada
    • University of Alberta
  • Hamilton, Canada
    • McMaster University
  • Alberta
    • Calgary, Alberta, Canada
      • University Of Calgary
  • Ontario
    • Toronto, Ontario, Canada
      • University of Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Minimum 20 weeks prior to date of LSS surgery
• Older than 55 years of age
• Scheduled for first spinal surgery
• Can read and understanding English, with no significant visual or hearing impairment that would require additional support

Exclusion Criteria:

• Known or suspected pathology (e.g., cancer, cauda equina syndrome)
• Unable to engage in exercise due to other comorbidities
• No access to the Internet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation; The 8-week prehabilitation program will be delivered online using synchronous and asynchronous sessions delivered by either a physiotherapist, chiropractor or kinesiologist. There will be 4 individual exercises sessions delivered synchronously using Zoom or Physitrack in which motivational interviewing and graded activity exercises will be conducted. Participants will also be asked to exercise at least 3 times a week using the asynchronous exercise videos. The exercises will be individualized on participants functional ability and personal goals identified at baseline, with a focus on muscle strengthening, stretching, improving spinal flexibility and stability. There will be a booster session at 6-weeks post-op. Participants will also undergo 5 group educational sessions, which will provide information regarding: goal setting, pain education, self-management, pacing, post-operative expectations, exercise recommendations, and information regarding their upcoming surgery.	Other: Prehab for LSS; The 8-week prehabilitation program will be delivered online by physiotherapists, chiropractors, and kinesiologists through synchronous and asynchronous exercise sessions, along with online educational sessions.
Active Comparator: Usual Care; Participants in the control group will receive usual care as per surgeons' current practice. This generally consists of one session with an anesthesiologist, a nurse and access to our online videos.	Other: Usual Care; Participants in the control group will receive usual care as per surgeons' current practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Adherence	Measured by patient diary, app-based program; Proceed with study if 80% of participants attended all 4 exercise sessions; Proceed with study if 60% of participants report exercise at last 3x/week.	During the 8-week Intervention
Recruitment Rate	Proceed with study if 50% of eligible participants consent to participate within 4 months	20 weeks before LSS surgery
Content Acceptability	Measured using a survey administered at the end of the 8-week intervention; Proceed with the study if 60% found treatment useful (>7/10 on a Likert scale); Proceed with the study if 60% found treatment helpful (>7/10 on a Likert scale)	Immediately after the intervention (8-weeks)
Format Acceptability	Measured using a survey administered at the end of the 8-week intervention; Proceed with the study if 60% found treatment delivery acceptability (>7/10 on a Likert scale); Proceed with the study if 60% of participants reported being likely to recommend this treatment (>7/10 on a Likert scale); Proceed with the study if 60% reported being likely to use this treatment again (>7/10 on a Likert scale)	Immediately after the intervention (8-weeks)
Follow-up	Proceed with the study if 90% of participants follow-up at the end of the prehab intervention; Proceed with the study if 85% of participants follow-up at 6 months; Proceed with the study if 85% of participants follow-up at 12 months; Proceed with the study if 60% reported being likely to use this treatment again (>7/10 on a Likert scale)	Immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Burden	Proceed with the study if 60% reported being likely to use this treatment again (>7/10 on a Likert scale)	Immediately after the intervention (8-weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Oswestry Disability Index	Disease specific questionnaire designed to evaluate pain and function in this patient population, using a numerical rating scale.	20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Swiss Spinal Stenosis Questionnaire - Balance	Disease specific questionnaire designed to evaluate pain and function in this patient population.	20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
SF-12	12-Item scale to assess the impact of health on quality of life.	20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Patient Health Questionnaire-9	Depression scale to monitor the severity of depression; total score from 0-27 with higher scores representing severe depression.	20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Pain Catastrophizing Scale	13-item scale to assess the extent of catastrophic thinking due to low back pain. Total score ranging from 0-52, along with three subscale scores assessing rumination, magnification and helplessness.	20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
6-item Chronic Disease Self-Efficacy Scale	6-item scale to evaluate disease related self-efficacy with higher scores indicating higher self-efficacy ranging from 0-10.	20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Tampa Scale of Kinesiophobia	11-item scale used to evaluate kinesiophobia and associated anxiety. Scores range from 17-68 with higher scores indicating severe kinesiophobia.	20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Ecological Momentary Assessment	Total weekly minutes of physical activity (PA) will be captured with a wearable tri-axial accelerometer device (Actiwatch Spectrum Pro Startup, Philips, USA) worn for seven consecutive days. Pain and fatigue will be measured using a 10-point scale with higher scores representing worse pain and fatigue, which will be measured 3 times a day for 7 days.	During the 8-week Intervention
EQ-5D	Measures five dimensions of patient reported health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).	20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: University of Alberta; University of Calgary
• Investigators: Principal Investigator: Doug Gross, PhD, University of Alberta; Principal Investigator: Kenneth Thomas, MD, University Of Calgary; Principal Investigator: Luciana G Macedo, PhD, McMaster University; Principal Investigator: Lisa Carlesso, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Prehabilitation; Exercise therapy; Spinal stenosis
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: Prehab LSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data may be requested directly to the principal investigator or may be made available upon publication.
• IPD Sharing Time Frame: Data will be available following publication of the results, and kept for at least 5 years to allow for the publication of findings.
• IPD Sharing Access Criteria: Ethics approval will be required for any secondary analysis of data as per HiREB approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No