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Feasibility of Prehab for Lumbar Spinal Stenosis

Primary Purpose

Lumbar Spinal Stenosis, Prehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prehab for LSS
Usual Care
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Prehabilitation, Spinal stenosis, Surgery, Exercise therapy

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of CalgaryRecruiting
  • University of Toronto
  • University of AlbertaRecruiting
  • McMaster UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prehabilitation

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Recruitment Rate
Proceed with study if 50% of eligible participants consent to participate within 4 months
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)
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)
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)
Burden
Proceed with the study if 60% reported being likely to use this treatment again (>7/10 on a Likert scale)

Secondary Outcome Measures

The Oswestry Disability Index
Disease specific questionnaire designed to evaluate pain and function in this patient population, using a numerical rating scale.
Swiss Spinal Stenosis Questionnaire - Balance
Disease specific questionnaire designed to evaluate pain and function in this patient population.
SF-12
12-Item scale to assess the impact of health on quality of life.
Patient Health Questionnaire-9
Depression scale to monitor the severity of depression; total score from 0-27 with higher scores representing severe depression.
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.
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.
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.
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.
EQ-5D
Measures five dimensions of patient reported health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).

Full Information

First Posted
September 27, 2021
Last Updated
June 2, 2023
Sponsor
McMaster University
Collaborators
University of Calgary, University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05073081
Brief Title
Feasibility of Prehab for Lumbar Spinal Stenosis
Official Title
Feasibility Testing of a Pre-surgical Rehabilitation (Prehab) Program for Patients With Lumbar Spinal Stenosis: a Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
University of Calgary, University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis, Prehabilitation
Keywords
Prehabilitation, Spinal stenosis, Surgery, Exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a mixed methods two-armed pilot RCT evaluating an 8-week virtual prehabilitation program for participants undergoing LSS surgery versus usual care. A longitudinal qualitative study will be conducted parallel to the pilot RCT.
Masking
None (Open Label)
Masking Description
Blinding of participants and those delivering the intervention is not possible within rehabilitation trials and blinding of assessors is not possible when participants are not blinded, and outcomes are self-reported. Research coordinators involved in data collection and researchers involved in data analysis, however, will be blinded.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Prehab for LSS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Participants in the control group will receive usual care as per surgeons' current practice.
Primary Outcome Measure Information:
Title
Patient Adherence
Description
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.
Time Frame
During the 8-week Intervention
Title
Recruitment Rate
Description
Proceed with study if 50% of eligible participants consent to participate within 4 months
Time Frame
20 weeks before LSS surgery
Title
Content Acceptability
Description
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)
Time Frame
Immediately after the intervention (8-weeks)
Title
Format Acceptability
Description
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)
Time Frame
Immediately after the intervention (8-weeks)
Title
Follow-up
Description
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)
Time Frame
Immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Title
Burden
Description
Proceed with the study if 60% reported being likely to use this treatment again (>7/10 on a Likert scale)
Time Frame
Immediately after the intervention (8-weeks)
Secondary Outcome Measure Information:
Title
The Oswestry Disability Index
Description
Disease specific questionnaire designed to evaluate pain and function in this patient population, using a numerical rating scale.
Time Frame
20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Title
Swiss Spinal Stenosis Questionnaire - Balance
Description
Disease specific questionnaire designed to evaluate pain and function in this patient population.
Time Frame
20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Title
SF-12
Description
12-Item scale to assess the impact of health on quality of life.
Time Frame
20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Title
Patient Health Questionnaire-9
Description
Depression scale to monitor the severity of depression; total score from 0-27 with higher scores representing severe depression.
Time Frame
20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Title
Pain Catastrophizing Scale
Description
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.
Time Frame
20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Title
6-item Chronic Disease Self-Efficacy Scale
Description
6-item scale to evaluate disease related self-efficacy with higher scores indicating higher self-efficacy ranging from 0-10.
Time Frame
20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Title
Tampa Scale of Kinesiophobia
Description
11-item scale used to evaluate kinesiophobia and associated anxiety. Scores range from 17-68 with higher scores indicating severe kinesiophobia.
Time Frame
20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively
Title
Ecological Momentary Assessment
Description
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.
Time Frame
During the 8-week Intervention
Title
EQ-5D
Description
Measures five dimensions of patient reported health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
Time Frame
20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luciana G Macedo, PhD
Phone
289-426-0824
Email
macedol@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie M Di Pelino, MPH
Phone
905-525-9140
Ext
23811
Email
dipelins@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana G Macedo, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doug Gross, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Carlesso, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Thomas, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doug Gross, PT, PhD
First Name & Middle Initial & Last Name & Degree
Ken Thomas, MD
First Name & Middle Initial & Last Name & Degree
Flo Slomp, PhD
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciana Macedo, PT, PhD
First Name & Middle Initial & Last Name & Degree
Raja Rampersaud, MD
Facility Name
University of Alberta
City
Edmonton
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doug Gross, PhD
First Name & Middle Initial & Last Name & Degree
Doug Gross, PhD
First Name & Middle Initial & Last Name & Degree
Rob Smeets, PhD
First Name & Middle Initial & Last Name & Degree
Geoff Schneider, PhD
First Name & Middle Initial & Last Name & Degree
Andrew Nataraj, MD
First Name & Middle Initial & Last Name & Degree
Brit Chase, DPT
Facility Name
McMaster University
City
Hamilton
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciana Macedo, PhD
First Name & Middle Initial & Last Name & Degree
Lisa Carlesso, PhD
First Name & Middle Initial & Last Name & Degree
Luciana Macedo, PhD
First Name & Middle Initial & Last Name & Degree
Nora Bakaa, DC
First Name & Middle Initial & Last Name & Degree
Joy MacDermid, PhD
First Name & Middle Initial & Last Name & Degree
Aleksa Cenic, MD
First Name & Middle Initial & Last Name & Degree
Pahuta Markian, MD
First Name & Middle Initial & Last Name & Degree
Raja Rampersaud, MD
First Name & Middle Initial & Last Name & Degree
Stephanie DiPelino
First Name & Middle Initial & Last Name & Degree
Brian Drew, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Feasibility of Prehab for Lumbar Spinal Stenosis

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