Postoperative Telehealth Mindfulness Intervention After Spine Surgery
CompletedNot applicableNCT04648683
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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)
Lumbar spine pain is the leading cause of years lived with a disability and affects over 50 million individuals in the United States. Rates of spine surgeries performed to address degenerative spine conditions have increased markedly. A subset of patients experience poor pain, functional, or quality of life outcomes after surgery. This study will adapt and evaluate the feasibility and potential benefits of both a one-on-one and a group-delivered, face-to-face telehealth, mindfulness intervention for patients recovering from lumbar spine surgery. The goals of the intervention are to improve short and long-term pain management, reduce the need for long-term pain medications, and improve physical and psychological well-being after surgery. The study will result in a refined intervention manual based on feasibility, participant exit interviews and satisfaction surveys which will be piloted in a future randomized controlled trial.
Study details
- Official title
- Postoperative Telehealth Mindfulness Intervention to Improve Pain-related Outcomes and Reduce Opioid Use After Lumbar Spine Surgery
- Conditions
- Chronic Low-back Pain
- Postsurgical Pain
- Opioid Use
- Lumbar Spine Surgery
- Interventions
- Behavioral: Individual telehealth mindfulness
- Behavioral: Group telehealth mindfulness
- Sponsor
- Vanderbilt University Medical Center
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2021-12-21
- Primary completion
- 2022-08-25
- Sex
- All
- Age range
- from 18 Years to 90 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. Between the ages of 18 and 90 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 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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04648683