Clinical trial NCT06808022: Influence of Pre-operative Back Muscle Exercise on Post-operative Outcomes After Spine Surgery
Official title: Influence of Pre-operative Back Muscle Exercise on Post-operative Outcomes After Spine Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Spine Pain
Spine Surgery
Keywords: Prehabilitation
Exercise
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Surgical Revision
timeFrame: 1 year
Secondary outcomes:
measure: Length of stay
timeFrame: 3 months
measure: Numeric Pain Rating Scale
timeFrame: 1 year
measure: Disability
timeFrame: 1 year
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
References: