Spine PainNCT06808022
Influence of Pre-operative Back Muscle Exercise on Post-operative Outcomes After Spine Surgery
A study testing Preoperative Resistance Exercise in people with Spine Pain and Spine Surgery, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Pain, Spine Surgery
- What is being tested?
- Preoperative Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Jan 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Individuals undergoing spinal surgery
- Individuals who have been deemed medically safe to participate in an exercise-based physical therapy program
Who cannot join
- - 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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:
- 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.
- Conditions
- Spine Pain, Spine Surgery
- Being tested
- Preoperative Resistance Exercise
- Keywords
- Prehabilitation, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Resistance ExerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control/Standard of Care | No intervention | Standard of Care preoperatively per surgeon recommendation |
| Preoperative Resistance exercise | Experimental | Resistance based exercise targeting the back muscles above where the intended surgery is planned Receives: Behavioral: Preoperative Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Revision
Patient requires surgical revision within 1 year of index surgery
Measured: 1 year
Secondary outcomes (3)
Length of stay
Postoperative hospital length of stay
Measured: 3 months
Numeric Pain Rating Scale
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
Measured: 1 year
Disability
Oswestry Disability Index, in percent, from 0-100. 0 indicating 0% disabled from back pain, and 100% indicating complete disability due to back pain.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Feb 2024
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine PainStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Shahidi, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808022
- Sponsor's protocol ID
- 803198
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pre-operative Back Muscle Exercise on Post-operative Outcomes After Spine Surgery
- ClinicalTrials.gov ID
- NCT06808022
- Acronym / sponsor ID
- 803198
- Conditions
- Spine Pain, Spine Surgery
- Keywords
- Prehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control/Standard of Care | No intervention | –Standard of Care preoperatively per surgeon recommendation |
| Preoperative Resistance exercise | Experimental | Behavioral: Preoperative Resistance ExerciseResistance based exercise targeting the back muscles above where the intended surgery is planned |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - Individuals undergoing spinal surgery
- Individuals who have been deemed medically safe to participate in an exercise-based physical therapy program
Key exclusion criteria (3 listed)
- - 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Resistance ExerciseParticipants 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 | Behavioural | Preoperative Resistance exercise |
Primary outcome
Surgical Revision
Time frame: 1 year
Patient requires surgical revision within 1 year of index surgery
3 secondary outcomes
Length of stay
Time frame: 3 months
Numeric Pain Rating Scale
Time frame: 1 year
Disability
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Resistance Exercise in people with Spine Pain and Spine Surgery, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Revision (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.