Feasibility of Prehab for Lumbar Spinal Stenosis

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073081
• Other study ID #: Prehab LSS
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: McMaster University
• Contact: Luciana G Macedo, PhD
• Phone: 289-426-0824
• Email: macedol[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Usual Care
Participants in the control group will receive usual care as per surgeons' current practice.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton
Canada	McMaster University	Hamilton
Canada	University of Toronto	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	University of Alberta, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Recruitment Rate	Proceed with study if 50% of eligible participants consent to participate within 4 months	20 weeks before LSS surgery
Primary	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)
Primary	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)
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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