Does a Pre-operative Exercise Program Improve Post-operative Outcomes for Fusion Patients

Does a Pre-operative Exercise Program Improve Post-operative Outcomes in Patients Undergoing Spinal Fusion Surgery for Adolescent Idiopathic Scoliosis?

A study found that in 1744 patients undergoing fusion surgery for adolescent Idiopathic scoliosis, 12% had back pain remaining after recovering from surgery. Rehabilitation prior to spine surgery or prehabilitation (prehab), has been shown to reduce costs and improve functional outcomes in patients who have had total hip or total knee arthroplasties. There is a lack of literature looking at prehab in the context of spine surgeries. The purpose of this study is to see if prehab can improve patient outcomes such as decreased pain, decreased length of stay in the hospital, and improved functional outcomes in patients undergoing fusion surgery for adolescent idiopathic scoliosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Behavioral: Prehabilitation Exercise Group

Detailed Description

Adolescent idiopathic scoliosis (AIS) is the most common spinal deformity in adolescents and literature suggests that the link between back pain and AIS is underreported. Core stabilization exercises and scoliosis specific exercises have been shown to increase SRS scores related to pain (higher SRS scores indicate lower levels of pain). Additionally, higher SRS scores at pre-op were associated with a lower risk of residual postoperative pain following a fusion surgery. This suggests that preoperative exercise programs should lead to an increase in SRS pain scores post-operatively however, this direct relationship has not been researched. Rehabilitation exercises prior to surgery has been shown to improve functional outcomes in knee and hip arthroplasties however, the rehabilitation preoperatively has not been studies in the context of spine surgeries. The purpose of this study is to evaluate whether the prehabilitation exercise program can improve post-op outcomes including length of stay, decreased pain, decreased length of stay, and improved functional outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shaina Sim, BSc; Phone Number: 2359 6048752000; Email: shaina.sim@cw.bc.ca
• Study Contact Backup: Name: Firoz Miyanji, MD; Email: fmiyanji@cw.bc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Included patients will have a diagnosis of AIS (ages 11-18). They will have a curve angle requiring surgery and be on the waitlist for surgery.

Exclusion Criteria:

• Patients will be excluded if they are currently enrolled in a physiotherapy designed exercise program prior to being enrolled in the study.
• They will be excluded if they have additional medical issues, limiting their ability to participate fully in the exercise program.
• Individuals with any cognitive disability that affects their ability to complete the questionnaires or follow instructions for the exercise program will also be excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care Group
Experimental: Prehabilitation Exercise Group; The exercise arm participants will be asked to complete weekly questionnaires which will take around 10 minutes each week and the exercise program which takes 30 minutes each day.	Behavioral: Prehabilitation Exercise Group; A set of core stabilization exercises and scoliosis specific exercises will be given to patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome	The primary analysis for the primary outcome length of stay is to determine if the prehab program reduces the average length of stay. It will follow the intention to treat approach, which will include all randomized participants retained in the group to which they are allocated. A complete analysis will be conducted to compare the outcomes between the two arms, utilizing the Student's t test or Wilcoxon-Mann-Whitney test, as appropriate for the distribution of the data. If more than 10% of randomized participants have missing length of stay outcomes, the missing data will be imputed using the Last Observation Carried Forward approach, as a sensitivity analysis.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Outcome	The pain outcomes will be measured using the Visual Analogue Scale (VAS); a scale ranging from 0 - 10, where 0 indicates no pain, and 10 indicates extreme pain.	2 years
Functional Outcome	The functional outcomes will be measured using the Scoliosis Research Society 22-item questionnaire (SRS-22). In this questionnaire, responses correspond to numbers 1 - 5, where 1 is the worst possible outcome and 5 is the best possible outcome. There will be a total SRS-22 score (average of all the scores) and five sub scores. The sub scores will be divided into five groups: function, pain, self-image, mental health, and satisfaction with management. Answers to questions relating to these categories will be averaged for each sub score.	2 years

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: H22-02186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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