Feasibility of Prehab for Lumbar Spinal Stenosis

NCT ID: NCT05073081

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2024-09-30

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.

Conditions

Lumbar Spinal Stenosis; Prehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prehab for LSS

Intervention Type: OTHER

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. This generally consists of one session with an anesthesiologist, a nurse and access to our online videos.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Usual Care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Luciana Macedo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciana G Macedo, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Doug Gross, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Lisa Carlesso, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Kenneth Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

University of Toronto

Toronto, Ontario, Canada

University of Alberta

Edmonton, , Canada

McMaster University

Hamilton, , Canada

Countries

Canada

Other Identifiers

Prehab LSS

Identifier Type: -

Identifier Source: org_study_id