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Not Yet Recruiting NCT05669027

Mobile Neurofeedback for Low Back Pain

Conditions: Chronic Low Back Pain

Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 150
Sponsor: Duke University

Location: United States

Summary

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 and video conference.

Eligibility Criteria

Inclusion Criteria:Responding greater than 3 months to "How long has low back pain been an ongoing problem for you?"Responding 'at least half the days' to "How often has low back pain been an ongoing problem for you over the past 6 months?"Investigators will follow recommendations to items and responses provided by the NIH Task Force on Research Standards for Chronic Low Back Pain, which specifically: "recommended 2 questions to achieve the definition of chronic low back pain: (1) How long has back pain been an ongoing problem for you? (2) How often has low back pain been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1 and a response of 'at least half the days in the past 6 months' to question 2 would define chronic lower back pain."Exclusion Criteria:History of seizures.Planning pain-related surgery in the next 9 months.Individuals with implanted medical devices that could experience interference during EEG and/or ECG, such as a spinal cord stimulator or pacemaker.Lower back pain is associated with a specific diagnosis (e.g., spinal stenosis).Lower back pain is associated with compensation or litigation issues.Rating of past week pain intensity<4 on 0-10 point scale.Rating of past week pain interference<4 on 0-10 point scale.Neurofeedback may increase risk of seizures among individuals with epilepsy or seizure disorder; thus the investigators will exclude individuals with a history of seizures. Individuals with plans for pain-related surgery in the next 9 months will be excluded. Consistent with published NIH-funded clinical trials enrolling adults with chronic low back pain, individuals will be excluded if back pain is associated with a specific diagnosis (e.g., spinal stenosis), if back pain is associated with compensation or litigation issues, or if individuals rate pain intensity<4 or rate pain interference<4 on 0-10 point scales.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05669027). StuddyBuddy aggregates publicly available trial information.