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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?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06076577
Enrollment
104
Registered
2023-10-11
Start date
2023-11-01
Completion date
2025-12-01
Last updated
2023-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis

Brief summary

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.

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.

Interventions

A set of core stabilization exercises and scoliosis specific exercises will be given to patients.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome2 yearsThe 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.

Secondary

MeasureTime frameDescription
Pain Outcome2 yearsThe 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.
Functional Outcome2 yearsThe 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.

Contacts

Primary ContactShaina Sim, BSc
shaina.sim@cw.bc.ca6048752000
Backup ContactFiroz Miyanji, MD
fmiyanji@cw.bc.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026