RECRUITING

Mobile Neurofeedback for Low Back Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to learn more about improving the quality of treatments for people who have chronic low back pain. Participants will complete interviews with Duke researchers at four different time points: the beginning of the study, at 3 months, at 6 months, and at 9 months. Participants will be asked to use a mobile app and a headset that are designed to train the brain to be more relaxed. Participants will use the mobile app for 10 minutes at a time, four times a week for three months. The study team will also check in with participants about app use six times throughout the study, via phone or video conference.

Official Title

Effective Self-Management of Chronic Pain With mHealth Neurofeedback

Quick Facts

Study Start:2023-10-02
Study Completion:2027-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05669027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Responding greater than 3 months to "How long has low back pain been an ongoing problem for you?"
  2. 2. Responding 'at least half the days' to "How often has low back pain been an ongoing problem for you over the past 6 months?"
  1. 1. History of seizures.
  2. 2. Planning pain-related surgery in the next 9 months.
  3. 3. Individuals with implanted medical devices that could experience interference during EEG and/or ECG, such as a spinal cord stimulator or pacemaker.
  4. 4. Lower back pain is associated with compensation or litigation issues.
  5. 5. Rating of past week pain intensity\<4 on 0-10 point scale.
  6. 6. Rating of past week pain interference\<4 on 0-10 point scale.

Contacts and Locations

Study Contact

Janequia Evans
CONTACT
919-681-1613
DBHTL@duke.edu
Betsy Serrano
CONTACT
919-681-1613
DBHTL@duke.edu

Principal Investigator

Eric Elbogen, Ph.D.
PRINCIPAL_INVESTIGATOR
Duke - Professor in Psychiatry and Behavioral Sciences

Study Locations (Sites)

Duke University Medical Center, Department of Psychiatry
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Duke University

  • Eric Elbogen, Ph.D., PRINCIPAL_INVESTIGATOR, Duke - Professor in Psychiatry and Behavioral Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-02
Study Completion Date2027-05-01

Study Record Updates

Study Start Date2023-10-02
Study Completion Date2027-05-01

Terms related to this study

Keywords Provided by Researchers

  • Neurofeedback
  • Biofeedback
  • Mobile Device
  • chronic low back pain
  • Pain Intensity
  • Relaxation
  • mHealth
  • Opioid

Additional Relevant MeSH Terms

  • Chronic Low Back Pain