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OpenTrials
Enrolling by Invitation

NCT Number: NCT06808022

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego

La Jolla, California, 92093, United States

About this study

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:

  • Pre-habilitation treatment arm
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Preoperative Resistance Exercise

Behavioral

Participants will have been deemed to be medically safe to participate in exercise-based physical therapy based on their physician recommendation and may also undergo an in-person evaluation by a licensed physical therapist to evaluate their physical capacity. This will inform the frequency and intensity of exercise prescription according to a participant's identified physical impairments and activity tolerance levels. Based on this information, an exercise program will be implemented either via web-based HIPAA compliant platforms (e.g. Zoom or WebEx) or in the clinic(e.g if the participant does not have internet access) on a 1-2x/week basis for the 4-6 week pre-operative duration. Each exercise session will be approximately 30 minutes. During these sessions, exercises including gravity-assisted, body-weighted, or body-weight-augmented resistance exercises targeting the paraspinal extensor muscles (multifidus, erector spinae, latissimus dorsi, lower trapezius) will be performed at a mo

Primary outcomes

  1. Surgical Revision

    Time frame: 1 year

    Patient requires surgical revision within 1 year of index surgery

Secondary outcomes

  1. Length of stay

    Time frame: 3 months

    Postoperative hospital length of stay

  2. Numeric Pain Rating Scale

    Time frame: 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

  3. Disability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2024
Primary completion
2030
Study completion
2035
First posted
Feb 4, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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