Telehealth Mindfulness After Spine Surgery
CompletedNot applicableNCT05698914
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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: 1. Is it feasible and acceptable to deliver the interventions and conduct the study procedures in this patient population? 2. 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: 1. Complete self-report questionnaires online before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery. 2. Complete a sensory pain task before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery. 3. 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).
Study details
- Official title
- Postoperative Telehealth Mindfulness Intervention After Lumbar Spine Surgery: Pilot Randomized Controlled Trial
- Conditions
- Lumbar Spine Surgery
- Chronic Low-back Pain
- Postsurgical Pain
- Interventions
- Behavioral: Telehealth mindfulness-based intervention (MBI)
- Behavioral: Telehealth Education
- Sponsor
- Vanderbilt University Medical Center
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2023-02-22
- Primary completion
- 2025-07-11
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. English-speaking adults 2. Aged 18 years and older 3. Scheduled for a laminectomy and/or fusion at Vanderbilt Spine Center 4. Scheduled for their first lumbar spine surgery 5. Radiographic evidence of a degenerative condition including but not limited to spinal stenosis, spondylosis with or without myelopathy, and spondylolisthesis 6. Presence of back and/or lower extremity pain persisting for at least 3 months 7. Access to stable internet. 8. Able to participate in weekly, remote sessions with a study therapist for 8 weeks after surgery Exclusion Criteria: 1. Microsurgical technique as the primary procedure (i.e. isolated laminotomy or microdiscectomy) 2. Having surgery for the primary indication of a spinal deformity 3. Having surgery secondary to pseudarthrosis, trauma, infection, or tumor 4. Current/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. 5. Diagnosis of Alzheimer's disease or another form of dementia 6. Traumatic Brain Injury (greater than mild severity) 7. History of bipolar disorder or dissociative disorder 8. Active substance use disorder (in past month) 9. Current Posttraumatic Stress Disorder (PTSD) symptoms (in past month) 10. Active suicidal ideation with intent
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05698914