Recruiting

Neurosurgery & Orthopedics

Sponsor:

Duke University

Code:

NCT04140344

Conditions

Lumbar Spine Degeneration

Lumbar Spine Instability

Lumbar Spondylosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Text Message Group

Study Details

Brief 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.

Conditions

Lumbar Spine Degeneration

Lumbar Spine Instability

Lumbar Spondylosis

Study ID

NCT04140344

Start date

Sep 7, 2023

Status verified date

May, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Primary lumbar fusion 1-4 levels
2. 18 years or older
3. Degenerative spine diagnosis
4. 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?

Exclusion Criteria:

1. Prior lumbar fusions
2. Tumors/infection/trauma
3. Prisoners or institutionalized patients
4. Non-English speaking patients
5. Patients who smokes or with uncontrolled diabetes
6. 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)

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: ARM 1: Text Message Group

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.

no intervention: ARM 2: Control group

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.

Interventions

Text Message Group

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.

Primary outcome measure

  • Change in readmission rates within 30 days post-lumbar spine surgery. [ Time Frame: Baseline, 30 days ]

Central Contacts and Locations

Central contacts

Locations

Duke Neurosurgery and Duke Orthopedics

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Oren N Gottfried, MD FAANS

More Information

Sponsor

Duke University

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Lumbar Fusion
  • Text Message

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-08.