Influence of Pre-operative Back Muscle Exercise on Post-operative Outcomes After Spine Surgery

Not Applicable

• Conditions: Spine Pain; Spine Surgery

• Registration Number: NCT06808022
• Lead Sponsor: University of California, San Diego

Brief Summary

The purpose of this research study is to gather more information about how improving back muscle function before surgery might influence what happens to the spine and function after surgery. This may assist in developing ways to improve surgical outcomes and determine the benefit of pre-operative exercise, if any.

Detailed Description

The investigators intend to enroll patients from UCSD spine clinic. The investigators will include patients who are indicated for a spine surgery. Once participants are identified to be surgical candidates, and have an estimated surgical date that is 4-6 weeks from identification, the participants may undergo pre-operative procedures including a pre-operative evaluation and treatment by a physical therapist, data collection (demographics, medical history, etc.), and filling out relevant questionnaires. Patients will undergo their surgery as scheduled with the spine surgeon as part of their planned standard care unless the surgeon decides that the surgery is no longer necessary. Participation in research does not influence the surgeon's decision. Post-operatively, participants may be asked to undergo a post-operative evaluation and fill out questionnaires.

Upon identification of eligibility, participants may be randomized to one of two study arms using a random number generator. If group characteristics are observed to be unbalanced using this approach, participants may be matched according to demographic or surgical features:

1. Pre-habilitation treatment arm

2. Standard of Care arm Participants in the standard of care arm will undergo all pre-operative activities recommended by their surgeon as per standard care.

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2030-01-01
• Study Completion: 2035-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• • Individuals undergoing spinal surgery
• Individuals who have been deemed medically safe to participate in an exercise-based physical therapy program

Exclusion Criteria

• • Individuals with comorbid conditions or spinal injury inappropriate for participating in an exercise-based physical therapy program as determined by the surgeon (e.g. unstable vertebral fracture)
• Individuals that do not have the ability to commit to the therapy schedule either in-clinic or using the web-based interface
• Non-english speaking individuals (some questionnaires are validated only in English)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical Revision	1 year	Patient requires surgical revision within 1 year of index surgery

Secondary Outcome Measures

Name	Time	Method
Length of stay	3 months	Postoperative hospital length of stay
Numeric Pain Rating Scale	1 year	Numeric Pain Rating Scale for back and leg pain on a 0-10 scale, with 10 being worst pain imaginable and 0 being no pain
Disability	1 year	Oswestry Disability Index, in percent, from 0-100. 0 indicating 0% disabled from back pain, and 100% indicating complete disability due to back pain.

Trial Locations

Locations (1)

UC San Diego; 🇺🇸 La Jolla, California, United States