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Prehabilitation for Lumbar Spinal Stenosis

N/A

Recruiting

Led By Doug Gross, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for first spinal surgery

Minimum 20 weeks prior to date of LSS surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 weeks before lss surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively

Awards & highlights

Study Summary

This trial will test the feasibility of a prehabilitation program for patients undergoing lumbar spine surgery for lumbar spinal stenosis.

Who is the study for?

This trial is for individuals over 55 years old who are scheduled for their first spinal surgery due to lumbar spinal stenosis (LSS) and have at least 20 weeks before their operation. Participants must be able to read and understand English without significant visual or hearing impairments, have internet access, and be capable of exercising.Check my eligibility

What is being tested?

The study is testing the feasibility of a 'prehabilitation' program designed to improve recovery after LSS surgery compared with usual care. It aims to establish groundwork for a larger future trial by piloting this pre-surgery exercise protocol.See study design

What are the potential side effects?

Since the intervention involves prehab exercises, potential side effects may include typical exercise-related issues such as muscle soreness or strain. However, specific side effects will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for my first spinal surgery.

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It has been at least 20 weeks since my spine surgery.

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I am older than 55.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 weeks before lss surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 weeks before lss surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks before lss surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Burden

Content Acceptability

Follow-up

+3 more

Secondary outcome measures

6-item Chronic Disease Self-Efficacy Scale

EQ-5D

Ecological Momentary Assessment

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PrehabilitationExperimental Treatment1 Intervention

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 II: Usual CareActive Control1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

881 Previous Clinical Trials

2,597,826 Total Patients Enrolled

University of CalgaryOTHER

792 Previous Clinical Trials

869,094 Total Patients Enrolled

1 Trials studying Prehabilitation

110 Patients Enrolled for Prehabilitation

University of AlbertaOTHER

888 Previous Clinical Trials

384,898 Total Patients Enrolled

1 Trials studying Prehabilitation

30 Patients Enrolled for Prehabilitation

Media Library

Prehab for LSS Clinical Trial Eligibility Overview. Trial Name: NCT05073081 — N/A

Prehabilitation Research Study Groups: Prehabilitation, Usual Care

Prehabilitation Clinical Trial 2023: Prehab for LSS Highlights & Side Effects. Trial Name: NCT05073081 — N/A

Prehab for LSS 2023 Treatment Timeline for Medical Study. Trial Name: NCT05073081 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment recruiting participants presently?

"Affirmative. Clinicaltrials.gov's records demonstrate that this trial, initially published on December 1st 2021, is still accepting applications. Sixty individuals need to be gathered from 4 distinct clinical research sites."

Answered by AI

How many medical sites are hosting this research endeavor?

"Currently, this medical trial is being conducted in 4 different centres. These include Edmonton, Calgary and Toronto as well as a fourth site that has yet to be disclosed. Potential participants are encouraged to select the nearest clinic for their convenience when enrolling."

Answered by AI

What are the key objectives of this trial?

"This 8-week medical intervention seeks to lessen the burden of disease. To further assess its efficacy, secondary outcomes such as Swiss Spinal Stenosis Questionnaire - Balance and Oswestry Disability Index will be monitored, alongside Ecological Momentary Assessment measuring total weekly minutes of physical activity using a wearable tri-axial accelerometer device and 10-point scale for daily pain/fatigue assessment."

Answered by AI

How many participants can the trial accommodate?

"Affirmative. According to clinicaltrials.gov, this trial is still searching for participants and was initially made available on December 1st 2021. The study wishes to recruit 60 people from four distinct research centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of Prehab for Lumbar Spinal Stenosis

Luciana Macedo 2021. "Feasibility of Prehab for Lumbar Spinal Stenosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05073081.