Lumbar Spine DegenerationNOTICENCT04140344
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
A study testing Text Message Group in people with Lumbar Spine Degeneration and Lumbar Spine Instability, run by Duke University at 1 site in United States.
Trial summary
The purpose of this single-blind, randomized, controlled study is to assess the efficacy of "informative text messages" vs "traditional handouts" provided to lumbar spine surgery patients post-operatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylosis
- What is being tested?
- Text Message Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2023to Oct 2027
- Phase
- Interventional
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
- Primary lumbar fusion 1-4 levels
- 18 years or older
- Degenerative spine diagnosis
- Answers YES to all the following screening questions:
- Do you own a mobile phone that is capable of sending and receiving text messages?
- Do you know how to text and feel comfortable texting?
- Are you a regular (at least once a day) text-message user?
- Are you agreeable to regular contact?
Who cannot join
- Prior lumbar fusions
- Tumors/infection/trauma
- Prisoners or institutionalized patients
- Non-English speaking patients
- Patients who smokes or with uncontrolled diabetes
- Participants will be removed from study if discharged to a rehabilitation center or discharged beyond 7 days post-operatively (we are expecting ~15% of patients to be discharged to a rehabilitation center or discharged beyond 7 days post-operatively)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Neurosurgery and Duke Orthopedics
Durham, North Carolina, 27710
Claudia E Pamanes, MPH, 919-668-0897, claudia.pamanes@duke.edu
Beth Perry, RN, CCRP, (919) 681-2695, beth.perry@duke.edu
About this study
The purpose of this single-blind, randomized, controlled study is to assess the efficacy of "informative text messages" vs "traditional handouts" provided to lumbar spine surgery patients post-operatively.
Read the detailed description
A total of 224 adult patients (18 years or older) undergoing spinal fusion surgery at Duke University Hospital, will be recruited from the Duke Department of Neurosurgery and the Duke Department of Orthopedics. Participants will be consented and will complete standard of care outcomes questionnaires (Visual Analogue Scale, Oswestry Disability Index and Euro-Quol 5D) at the pre-operative clinic visit for baseline comparison. Participants will be randomized, through REDCap, with equal probability to either: A) the control group, with standard post-surgery handouts, or B) the experimental group, which will receive text messages for a period of 2 weeks after surgery (daily for the first week, and every other day for the second week). Text messages were designed to be standardized and automated, with an embedded link to a video regarding at-home, post-surgery-care instructions. Patients will be directed not to respond to the text messages, but to call for any questions or concerns. The primary outcome will be a reduction in 30-days post-surgery readmission rates. The secondary outcomes will be a reduction in 30-days post-surgery ED visits rates, back and leg pain scores, and anxiety levels. These outcomes will be assessed via a phone interview at 30-days (up to max of 37 days) post-discharge for both groups.
- Being tested
- Text Message Group
- Keywords
- Lumbar Fusion, Text Message
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message GroupOther
Also called Guidance via text messaging to lumbar spine surgery patients post-operatively
The intervention group will receive automated text messages every day for the first week, and every other day for the second week post-operatively. The text messages will follow a series of pre-defined standardized scripts (Appendix 3) with embedded hyperlinks to a video from the providers with further advice. The patient is directed not to respond to the text messages, but to call for any questions or concerns. The text message group will receive a 30-day post-operative phone call to evaluate: number of ED visits, hospital readmissions, and to re-administer the questionnaires completed at baseline visit. Other data to be collected may include the following: number of phone calls to provider, MyChart messages to provider, pain medications, and new problems like pain and infection.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1: Text Message Group | Experimental | The intervention group will receive automated text messages every day for the first week, and every other day for the second week post-operatively. The text messages will follow a series of pre-defined standardized scripts (Appendix 3) with embedded hyperlinks to a video from the providers with further advice. The patient is directed not to respond to the text messages, but to call for any questions or concerns. The text message group will receive a 30-day post-operative phone call to evaluate: number of ED visits, hospital readmissions, and to re-administer the questionnaires completed at baseline visit. Other data to be collected may include the following: number of phone calls to provider, MyChart messages to provider, pain medications, and new problems like pain and infection. Receives: Other: Text Message Group |
| ARM 2: Control group | No intervention | The control group will be given the standard post-op packet that includes detailed instructions on proper wound care and signs and symptoms of infection. They will not receive text messages. The same outcomes will be assessed in both groups through a 30-day post-operative phone call. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in readmission rates within 30 days post-lumbar spine surgery.
Change in readmission rates within 30 days post-lumbar spine surgery as measured by questionnaire.
Measured: Baseline, 30 days
Secondary outcomes (3)
Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery.
Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery as measured by questionnaire.
Measured: Baseline, 30 days
Change in back and leg pain levels within 30 days post-lumbar spine surgery as measured by "Oswestry Disability Index" (ODI) questionnaire.
ODI questionnaire is a tool to evaluate a subjective level of functional disability in daily living activities in patients with low back pain. Scores go from 0% (no disability) to 100% (maximum disability possible).
Measured: Baseline, 30 days
Change in anxiety/depression levels within 30 days post-lumbar spine surgery as measured by "European Quality of Life-5 Dimension" (EQ-5D) questionnaire.
The EQ-5D is an instrument to quantify health-related quality of life. Scores can be reported as a five digit number in a range from 11111 (full health) to 55555 (worst health).
Measured: Baseline, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start7 Sep 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine DegenerationStudies of the same condition, open and under way.
- More trials run by Duke 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following baseline assessments, subjects will be randomized with equal probability to one of two arms: 1). The experimental arm, which will receive automated standardized text messages at predetermined intervals, occurring daily the first week post-operatively and gradually tapering over the second week; 2). The control arm - where subjects will not receive any scheduled contact (outside of standard of care phone interactions). All subjects will receive a phone call 30 days (up to 37 days) post-discharge in order to complete the study questionnaires.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oren N Gottfried, MD FAANS, Principal investigator, Duke Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140344
- Sponsor's protocol ID
- Pro00103904
- Acronym
- NOTICE
- Status last verified
- May 2026
- First submitted
- 24 Oct 2019
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No