← Back to all trials
Not Yet Recruiting
NCT05698914
Telehealth Mindfulness After Spine Surgery
Conditions: Lumbar Spine Surgery, Chronic Low-back Pain, Postsurgical Pain
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 72
Sponsor: Vanderbilt University Medical Center
Summary
The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative spine condition.
The study aims to answer the following questions:Is it feasible and acceptable to deliver the interventions and conduct the study procedures in this patient population?Do the interventions benefit patients with regard to pain-related, functional, opioid use, and psychosocial outcomes at 3 and 6 months after surgery, and does one intervention have more benefit than the other?Participants will be asked to do the following:Complete self-report questionnaires online before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.Complete a sensory pain task before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.Around two weeks after surgery, participants will be randomly assigned by chance to one of two behavioral interventions - Mindfulness or Education.
Participants will then be asked to attend 8, weekly sessions with a study treatment coach over telehealth (online with camera and microphone).
Eligibility Criteria
Inclusion Criteria:English-speaking adultsAged 18 years and olderScheduled for a laminectomy and/or fusion at Vanderbilt Spine CenterScheduled for their first lumbar spine surgeryRadiographic evidence of a degenerative condition including but not limited to spinal stenosis, spondylosis with or without myelopathy, and spondylolisthesisPresence of back and/or lower extremity pain persisting for at least 3 monthsAccess to stable internet.Able to participate in weekly, remote sessions with a study therapist for 8 weeks after surgeryExclusion Criteria:Microsurgical technique as the primary procedure (i.e.
isolated laminotomy or microdiscectomy)Having surgery for the primary indication of a spinal deformityHaving surgery secondary to pseudarthrosis, trauma, infection, or tumorCurrent/history of a primary psychotic or major thought disorder or hospitalization for reasons related to psychosis (e.g.
Schizophrenia, brief psychotic disorder, delusional disorder).
Medication-induced psychosis is not exclusionary.Diagnosis of Alzheimer's disease or another form of dementiaTraumatic Brain Injury (greater than mild severity)History of bipolar disorder or dissociative disorderActive substance use disorder (in past month)Current Posttraumatic Stress Disorder (PTSD) symptoms (in past month)Active suicidal ideation with intent
Source: ClinicalTrials.gov (NCT05698914). StuddyBuddy aggregates publicly available trial information.