Spine Pain, Spine Surgery
Conditions
Keywords
Prehabilitation, Exercise
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.
Interventions
BEHAVIORALPreoperative Resistance Exercise
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
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Revision | 1 year | Patient requires surgical revision within 1 year of index surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed