This trial is active, not recruiting.

Conditions anxiety, pain, surgical site infection
Treatment cellular device/computers
Sponsor Duke University
Start date September 2012
End date December 2023
Trial size 194 participants
Trial identifier NCT01789697, Pro00034182


The objectives of this double-blind, randomized, controlled study are to evaluate the efficacy of maintaining contact with low-back pain patients through text messaging and emailing, to decrease anxiety levels, pain, number of follow-up visits through text messaging and emailing, and to improve reporting of surgical site infection after spine surgery through text messaging and emailing. The outcomes that will be measured are anxiety, pain, follow-up visits and received phone calls, and reporting signs of surgical site infection. Participants will include Dr. Oren Gottfried's patients who underwent spine surgery at Duke Hospital or at Duke Raleigh Hospital. Patients will be approached after determination that the patient is going to undergo spinal surgery. All patients meeting inclusion criteria will be approached to participate irrespective of race or ethnicity. A total of 194 subjects will be recruited.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose supportive care
Will receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.
cellular device/computers
A random group of patients will receive text messages to their cellular device from the surgeon, as well as emails to their email addresses.
(No Intervention)
Will not receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.

Primary Outcomes

Change in Anxiety
time frame: Day 1-21, Month 3, Month 12
Change in Pain
time frame: Day 1-21, Month 3, Month 12
Change in Surgical Site
time frame: Day 1-21

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

Inclusion Criteria: - Patients age greater than 18 years - Patients who confirm they have an unlimited text message data plan and email capabilities on their mobile device - Patients of Dr. Gottfried's underwent lumbar decompression or fusion surgery - Patients with text message capabilities - Patients who have an active email account Exclusion Criteria: - Patients who demonstrate an inability to fill out the pre-visit questionnaires - Patients with a diagnosis of metastatic disease - Patients with workers compensation or liability pending - Patients who will require transfer to an acute rehabilitation facility following surgery

Additional Information

Official title Using Mobile Phone Text Messaging and E-mailing to Decrease Anxiety, Pain, Follow-up Visits and Improve Reporting of Surgical Site Infection After Spine Surgery: A Double-Blind Randomized Trial
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Duke University.