Spine DiseaseNCT04379921

Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch

A study testing Apple Watch and App in people with Spine Disease and Spine Degeneration, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Spine Disease, Spine Degeneration, Spinal Stenosis
What is being tested?: Apple Watch and App
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 255 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2020to 30 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

English-speaking.
Undergoing elective spine surgery by attending physicians at Stanford University.
Own iPhone

Who cannot join

Patients with spine trauma, tumors, or infection.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University Hospital
Palo Alto, California, 94305

Other trials in United States

About this study

One of the primary goals of spine surgery is to reduce pain and increase mobility to improve patients' quality of life. Currently, there is no established method for surgeons to objectively track their patients' mobilization postoperatively. This study is the first prospective trial utilizing the Apple Watch to objectively track patients before and after elective spine surgery. The investigators hypothesize that the ability of patients to track their own activity and discuss with their surgeon objective mobilization goals will not only help patients achieve empowerment in their own care but also improve their overall satisfaction and self-reported outcomes after spine surgery.

Conditions: Spine Disease, Spine Degeneration, Spinal Stenosis, Surgery, Spine Fusion
Being tested: Apple Watch and App
Keywords: Spine Surgery, Apple Watch, Objective Tracking of Spine Surgery Outcomes
Medical subject headings: Spinal Diseases, Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Apple Watch and AppDevice
Participants in the Apple Watch and App arm will receive an Apple Watch and download an App (NeuroCoach). The Apple Watch and App are used for this study to record patient's mobility information (e.g., step counts, heart rate, stairs climbed, distance traveled) as well as provide an additional platform for patients to complete questionnaires.

Study groups in NCT04379921
Study group	Role	What they receive
Control	No intervention	Participants will receive standard care.
Apple Watch and App	Experimental	Participants will receive standard care, and an Apple Watch to record activity through the App. Receives: Device: Apple Watch and App

What is being measured

The primary outcome is the main question the study is designed to answer.

Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame.
- Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes.
- EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes.
- Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes.
- Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
- Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Measured: 2-6 weeks pre-operatively
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame.
- Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes.
- EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes.
- Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes.
- Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
- Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Measured: 4-6 weeks post-operatively
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame.
- Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes.
- EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes.
- Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes.
- Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
- Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Measured: 6 weeks-3 months post-operatively
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame.
- Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes.
- EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes.
- Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes.
- Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
- Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Measured: 3-6 months post-operatively
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame.
- Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes.
- EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes.
- Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes.
- Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
- Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Measured: 6-12 months post-operatively
Change in Objective Outcome Measures: Number of Steps After Surgery
Steps per day collected by Apple Watch were averaged across the respective outcome measure time frame. Change was calculated as the post-baseline value minus the baseline value (which was normalized to zero).
Measured: 2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively
Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery
Meters per day collected by Apple Watch were averaged across the respective outcome measure time frame. Change was calculated as the post-baseline value minus the baseline value (which was normalized to zero).
Measured: 2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Average hours wear time per day across the outcome measure time frame.
Measured: 2-6 weeks pre-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Average hours wear time per day across the outcome measure time frame.
Measured: 4-6 weeks post-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Average hours wear time per day across the outcome measure time frame.
Measured: 6 weeks-3 months post-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Average hours wear time per day across the outcome measure time frame.
Measured: 3-6 months post-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Average hours wear time per day across the outcome measure time frame.
Measured: 6-12 months post-operatively
Patient Satisfaction With Their Spine Care
Reported as the number of participants, by response category.
Measured: 6 weeks post-operatively
Patient Satisfaction With Their Spine Care
Reported as the number of participants, by response category.
Measured: 3 months post-operatively
Patient Satisfaction With Their Spine Care
Reported as the number of participants, by response category.
Measured: 6 months post-operatively
Patient Satisfaction With Their Spine Care
Reported as the number of participants, by response category.
Measured: 12 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202030 Nov 2024

First posted8 May 2020
Study start1 Sep 2020
Primary completion30 Nov 2024
Study completion30 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Spine DiseaseStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 255 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04379921
Sponsor's protocol ID: 52367
Status last verified: Mar 2025
First submitted: 30 Apr 2020
Last updated: 19 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Bernstein DN, Brodell D, Li Y, Rubery PT, Mesfin A. Impact of the Economic Downturn on Elective Lumbar Spine Surgery in the United States: A National Trend Analysis, 2003 to 2013. Global Spine J. 2017 May;7(3):213-219. doi: 10.1177/2192568217694151. Epub 2017 Apr 6.
PubMed 28660102
Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979-1990. Spine (Phila Pa 1976). 1994 May 15;19(10):1117-23; discussion 1123-4. doi: 10.1097/00007632-199405001-00003.
PubMed 8059266
O'Lynnger TM, Zuckerman SL, Morone PJ, Dewan MC, Vasquez-Castellanos RA, Cheng JS. Trends for Spine Surgery for the Elderly: Implications for Access to Healthcare in North America. Neurosurgery. 2015 Oct;77 Suppl 4:S136-41. doi: 10.1227/NEU.0000000000000945.
PubMed 26378351
Parker SL, Chotai S, Devin CJ, Tetreault L, Mroz TE, Brodke DS, Fehlings MG, McGirt MJ. Bending the Cost Curve-Establishing Value in Spine Surgery. Neurosurgery. 2017 Mar 1;80(3S):S61-S69. doi: 10.1093/neuros/nyw081.
PubMed 28350948
Epstein NE. A review article on the benefits of early mobilization following spinal surgery and other medical/surgical procedures. Surg Neurol Int. 2014 Apr 16;5(Suppl 3):S66-73. doi: 10.4103/2152-7806.130674. eCollection 2014.
PubMed 24843814
Guzman JZ, Cutler HS, Connolly J, Skovrlj B, Mroz TE, Riew KD, Cho SK. Patient-Reported Outcome Instruments in Spine Surgery. Spine (Phila Pa 1976). 2016 Mar;41(5):429-37. doi: 10.1097/BRS.0000000000001211.
PubMed 26571179
Lu TC, Fu CM, Ma MH, Fang CC, Turner AM. Healthcare Applications of Smart Watches. A Systematic Review. Appl Clin Inform. 2016 Sep 14;7(3):850-69. doi: 10.4338/ACI-2016-03-R-0042.
PubMed 27623763
Reeder B, David A. Health at hand: A systematic review of smart watch uses for health and wellness. J Biomed Inform. 2016 Oct;63:269-276. doi: 10.1016/j.jbi.2016.09.001. Epub 2016 Sep 6.
PubMed 27612974
Henriksen A, Haugen Mikalsen M, Woldaregay AZ, Muzny M, Hartvigsen G, Hopstock LA, Grimsgaard S. Using Fitness Trackers and Smartwatches to Measure Physical Activity in Research: Analysis of Consumer Wrist-Worn Wearables. J Med Internet Res. 2018 Mar 22;20(3):e110. doi: 10.2196/jmir.9157.
PubMed 29567635
Mobbs RJ, Phan K, Maharaj M, Rao PJ. Physical Activity Measured with Accelerometer and Self-Rated Disability in Lumbar Spine Surgery: A Prospective Study. Global Spine J. 2016 Aug;6(5):459-64. doi: 10.1055/s-0035-1565259. Epub 2015 Oct 13.
PubMed 27433430
Phan K, Mobbs RJ. Long-Term Objective Physical Activity Measurements using a Wireless Accelerometer Following Minimally Invasive Transforaminal Interbody Fusion Surgery. Asian Spine J. 2016 Apr;10(2):366-9. doi: 10.4184/asj.2016.10.2.366. Epub 2016 Apr 15.
PubMed 27114781
Breteler MJ, Janssen JH, Spiering W, Kalkman CJ, van Solinge WW, Dohmen DA. Measuring Free-Living Physical Activity With Three Commercially Available Activity Monitors for Telemonitoring Purposes: Validation Study. JMIR Form Res. 2019 Apr 24;3(2):e11489. doi: 10.2196/11489.
PubMed 31017587
Veerabhadrappa P, Moran MD, Renninger MD, Rhudy MB, Dreisbach SB, Gift KM. Tracking Steps on Apple Watch at Different Walking Speeds. J Gen Intern Med. 2018 Jun;33(6):795-796. doi: 10.1007/s11606-018-4332-y.
PubMed 29633143
Xie J, Wen D, Liang L, Jia Y, Gao L, Lei J. Evaluating the Validity of Current Mainstream Wearable Devices in Fitness Tracking Under Various Physical Activities: Comparative Study. JMIR Mhealth Uhealth. 2018 Apr 12;6(4):e94. doi: 10.2196/mhealth.9754.
PubMed 29650506
Maldaner N, Tang M, Fatemi P, Leung C, Desai A, Tomkins-Lane C, Zygourakis C. Standardizing Physical Activity Monitoring in Patients With Degenerative Lumbar Disorders. Neurosurgery. 2024 Apr 1;94(4):788-796. doi: 10.1227/neu.0000000000002755. Epub 2023 Nov 13.
PubMed 37955445

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
ClinicalTrials.gov ID: NCT04379921
Acronym / sponsor ID: 52367
Conditions: Spine Disease, Spine Degeneration, Spinal Stenosis, Surgery, Spine Fusion
Keywords: Spine Surgery, Apple Watch, Objective Tracking of Spine Surgery Outcomes
Study type: Interventional
Recruitment status: Completed
Enrolment: 255 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Stryker Nordic
Study start: 1 Sep 2020 (actual)
Primary completion: 30 Nov 2024 (actual)
Study completion: 30 Nov 2024 (actual)
First posted: 8 May 2020 (actual)
Results: Posted 19 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Participants will receive standard care.
Apple Watch and App	Experimental	Device: Apple Watch and AppParticipants will receive standard care, and an Apple Watch to record activity through the App.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

English-speaking.
Undergoing elective spine surgery by attending physicians at Stanford University.
Own iPhone

Key exclusion criteria (1 listed)

Patients with spine trauma, tumors, or infection.

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
Apple Watch and AppParticipants in the Apple Watch and App arm will receive an Apple Watch and download an App (NeuroCoach). The Apple Watch and App are used for this study to record patient's mobility information (e.g., step counts, heart rate, stairs climbed, distance traveled) as well as provide an additional platform for patients to complete questionnaires.	Device	Apple Watch and App

Primary outcome

Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Time frame: 2-6 weeks pre-operatively
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Time frame: 4-6 weeks post-operatively
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Time frame: 6 weeks-3 months post-operatively
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Time frame: 3-6 months post-operatively
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Time frame: 6-12 months post-operatively
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Change in Objective Outcome Measures: Number of Steps After Surgery
Time frame: 2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively
Steps per day collected by Apple Watch were averaged across the respective outcome measure time frame. Change was calculated as the post-baseline value minus the baseline value (which was normalized to zero).
Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery
Time frame: 2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively
Meters per day collected by Apple Watch were averaged across the respective outcome measure time frame. Change was calculated as the post-baseline value minus the baseline value (which was normalized to zero).
Patient Compliance With Wearing Apple Watch - Wear Time
Time frame: 2-6 weeks pre-operatively
Average hours wear time per day across the outcome measure time frame.
Patient Compliance With Wearing Apple Watch - Wear Time
Time frame: 4-6 weeks post-operatively
Average hours wear time per day across the outcome measure time frame.
Patient Compliance With Wearing Apple Watch - Wear Time
Time frame: 6 weeks-3 months post-operatively
Average hours wear time per day across the outcome measure time frame.
Patient Compliance With Wearing Apple Watch - Wear Time
Time frame: 3-6 months post-operatively
Average hours wear time per day across the outcome measure time frame.
Patient Compliance With Wearing Apple Watch - Wear Time
Time frame: 6-12 months post-operatively
Average hours wear time per day across the outcome measure time frame.
Patient Satisfaction With Their Spine Care
Time frame: 6 weeks post-operatively
Reported as the number of participants, by response category.
Patient Satisfaction With Their Spine Care
Time frame: 3 months post-operatively
Reported as the number of participants, by response category.
Patient Satisfaction With Their Spine Care
Time frame: 6 months post-operatively
Reported as the number of participants, by response category.
Patient Satisfaction With Their Spine Care
Time frame: 12 months post-operatively
Reported as the number of participants, by response category.

Results and safety

Results posted to the registry on 19 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	122	96
Apple Watch and App	133	96

Primary outcome: Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)

Time frame: 2-6 weeks pre-operatively. Number. Unit: correlation coefficient

Measure	Apple Watch and App n = 90
Steps to SF-36	0.160804476
Steps to EQ-5D	0.170547163
Steps to PROMIS	0.03133065
Steps to NDI	-0.287227624
Steps to ODI	-0.245495419
Distance traveled (meters) to SF-36	0.156072138
Distance traveled (meters) to EQ-5D	0.165543596
Distance traveled (meters) to PROMIS	0.047067760

Apple Watch and App: p = 0.26801155, Wilcoxon (Mann-Whitney)
Apple Watch and App: p = 0.27520264, Wilcoxon (Mann-Whitney)
Apple Watch and App: p = 0.95547874, Wilcoxon (Mann-Whitney)

Population analysed: Participants with data for the respective time frame and patient-reported outcome. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).

Primary outcome: Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)

Time frame: 4-6 weeks post-operatively. Number. Unit: correlation coefficient

Measure	Apple Watch and App n = 88
Steps to SF-36	0.237509597
Steps to EQ-5D	0.254596876
Steps to PROMIS	-0.061318768
Steps to NDI	-0.026754947
Steps to ODI	-0.237678247
Distance traveled (meters) to SF-36	0.251030049
Distance traveled (meters) to EQ-5D	0.249053662
Distance traveled (meters) to PROMIS	-0.044081635

Apple Watch and App: p = 0.09091440, Wilcoxon (Mann-Whitney)
Apple Watch and App: p = 0.12858419, Wilcoxon (Mann-Whitney)
Apple Watch and App: p = 0.95547874, Wilcoxon (Mann-Whitney)

Primary outcome: Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)

Time frame: 6 weeks-3 months post-operatively. Number. Unit: correlation coefficient

Measure	Apple Watch and App n = 85
Steps to SF-36	0.211745206
Steps to EQ-5D	0.137757731
Steps to PROMIS	-0.028651640
Steps to NDI	-0.195235044
Steps to ODI	-0.130278276
Distance traveled (meters) to SF-36	0.205169697
Distance traveled (meters) to EQ-5D	0.122267044
Distance traveled (meters) to PROMIS	-0.004087870

Apple Watch and App: p = 0.14778771, Wilcoxon (Mann-Whitney)
Apple Watch and App: p = 0.36288455, Wilcoxon (Mann-Whitney)
Apple Watch and App: p = 0.95547874, Wilcoxon (Mann-Whitney)

Primary outcome: Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)

Time frame: 3-6 months post-operatively. Number. Unit: correlation coefficient

Measure	Apple Watch and App n = 77
Steps to SF-36	0.299619225
Steps to EQ-5D	0.313524073
Steps to PROMIS	-0.086753507
Steps to NDI	-0.239505761
Steps to ODI	-0.322504210
Distance traveled (meters) to SF-36	0.293769111
Distance traveled (meters) to EQ-5D	0.308525815
Distance traveled (meters) to PROMIS	-0.067371364

Apple Watch and App: p = 0.06340316, Wilcoxon (Mann-Whitney)
Apple Watch and App: p = 0.08121447, Wilcoxon (Mann-Whitney)
Apple Watch and App: p = 0.95547874, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: Up to approximately 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 91 (0%)	0 of 91 (0%)	0 of 91
Apple Watch and App	0 of 96 (0%)	0 of 96 (0%)	0 of 96

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28660102Bernstein DN, Brodell D, Li Y, Rubery PT, Mesfin A. Impact of the Economic Downturn on Elective Lumbar Spine Surgery in the United States: A National Trend Analysis, 2003 to 2013. Global Spine J. 2017 May;7(3):213-219. doi: 10.1177/2192568217694151. Epub 2017 Apr 6.
Background: PubMed 8059266Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979-1990. Spine (Phila Pa 1976). 1994 May 15;19(10):1117-23; discussion 1123-4. doi: 10.1097/00007632-199405001-00003.
Background: PubMed 26378351O'Lynnger TM, Zuckerman SL, Morone PJ, Dewan MC, Vasquez-Castellanos RA, Cheng JS. Trends for Spine Surgery for the Elderly: Implications for Access to Healthcare in North America. Neurosurgery. 2015 Oct;77 Suppl 4:S136-41. doi: 10.1227/NEU.0000000000000945.
Background: PubMed 28350948Parker SL, Chotai S, Devin CJ, Tetreault L, Mroz TE, Brodke DS, Fehlings MG, McGirt MJ. Bending the Cost Curve-Establishing Value in Spine Surgery. Neurosurgery. 2017 Mar 1;80(3S):S61-S69. doi: 10.1093/neuros/nyw081.
Background: PubMed 24843814Epstein NE. A review article on the benefits of early mobilization following spinal surgery and other medical/surgical procedures. Surg Neurol Int. 2014 Apr 16;5(Suppl 3):S66-73. doi: 10.4103/2152-7806.130674. eCollection 2014.
Background: PubMed 26571179Guzman JZ, Cutler HS, Connolly J, Skovrlj B, Mroz TE, Riew KD, Cho SK. Patient-Reported Outcome Instruments in Spine Surgery. Spine (Phila Pa 1976). 2016 Mar;41(5):429-37. doi: 10.1097/BRS.0000000000001211.
Background: PubMed 27623763Lu TC, Fu CM, Ma MH, Fang CC, Turner AM. Healthcare Applications of Smart Watches. A Systematic Review. Appl Clin Inform. 2016 Sep 14;7(3):850-69. doi: 10.4338/ACI-2016-03-R-0042.
Background: PubMed 27612974Reeder B, David A. Health at hand: A systematic review of smart watch uses for health and wellness. J Biomed Inform. 2016 Oct;63:269-276. doi: 10.1016/j.jbi.2016.09.001. Epub 2016 Sep 6.
Background: PubMed 29567635Henriksen A, Haugen Mikalsen M, Woldaregay AZ, Muzny M, Hartvigsen G, Hopstock LA, Grimsgaard S. Using Fitness Trackers and Smartwatches to Measure Physical Activity in Research: Analysis of Consumer Wrist-Worn Wearables. J Med Internet Res. 2018 Mar 22;20(3):e110. doi: 10.2196/jmir.9157.
Background: PubMed 27433430Mobbs RJ, Phan K, Maharaj M, Rao PJ. Physical Activity Measured with Accelerometer and Self-Rated Disability in Lumbar Spine Surgery: A Prospective Study. Global Spine J. 2016 Aug;6(5):459-64. doi: 10.1055/s-0035-1565259. Epub 2015 Oct 13.
Background: PubMed 27114781Phan K, Mobbs RJ. Long-Term Objective Physical Activity Measurements using a Wireless Accelerometer Following Minimally Invasive Transforaminal Interbody Fusion Surgery. Asian Spine J. 2016 Apr;10(2):366-9. doi: 10.4184/asj.2016.10.2.366. Epub 2016 Apr 15.
Background: PubMed 31017587Breteler MJ, Janssen JH, Spiering W, Kalkman CJ, van Solinge WW, Dohmen DA. Measuring Free-Living Physical Activity With Three Commercially Available Activity Monitors for Telemonitoring Purposes: Validation Study. JMIR Form Res. 2019 Apr 24;3(2):e11489. doi: 10.2196/11489.
2017 Profile of Older AmericansLink provided by the sponsor.
Global Smartwatch Vendor Market ShareLink provided by the sponsor.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Corinna Zygourakis, MD principal investigator

Department of Neurosurgery at Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Apple Watch and App in people with Spine Disease and Spine Degeneration, run by Stanford University 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?

Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) (time frame: 2-6 weeks pre-operatively). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04379921, which also lists 15 linked publications.

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 19 Dec 2025.