N/A
N=10
Postoperative Telehealth Mindfulness Intervention After Spine Surgery
Chronic Low-back Pain · Postsurgical Pain · Opioid Use · Lumbar Spine Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04648683 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Feasibility - Study Retention — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Individual telehealth mindfulness (Behavioral); Group telehealth mindfulness (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility - Study Retention |
3 | — |
| PRIMARY Feasibility - Session Attendance |
3; 1; 1 | — |
| PRIMARY Acceptability - Satisfaction With Intervention |
53.0 | — |
| SECONDARY Pain Bothersomeness |
0.3 | — |
| SECONDARY Pain Interference Short-form 4a |
46.3 | — |
| SECONDARY Overall Pain Intensity |
0.7 | — |
| SECONDARY Back and Leg Pain Intensity |
0.7; 0.3 | — |
| SECONDARY Self-reported Opioid Medication Use |
0.0 | — |
| SECONDARY Anxiety Short Form 4a |
40.3 | — |
| SECONDARY Depression Short Form 4a |
43.6 | — |
| SECONDARY Oswestry Disability Index |
18.0 | — |
| SECONDARY Pain Catastrophizing Scale |
1.3 | — |
| SECONDARY Pain Self-efficacy Questionnaire |
52.7 | — |
| SECONDARY Perceived Stress Scale - 4 |
4.0 | — |
| SECONDARY Tampa Scale for Kinesiophobia -13 |
24.5 | — |
| SECONDARY Five Facet Mindfulness Questionnaire - 15 |
3.8 | — |
Summary
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.
Eligibility Criteria
Inclusion criteria
- English-speaking adults
- Between the ages of 18 and 90
- Scheduled for a laminectomy and/or fusion at Vanderbilt Spine Center
- Scheduled for their first lumbar spine surgery
- Radiographic evidence of a degenerative condition including but not limited to spinal stenosis, spondylosis with or without myelopathy, and spondylolisthesis
- Presence of back and/or lower extremity pain persisting for at least 3 months
- Access to stable internet.
- Able to participate in weekly, remote sessions with a study therapist for 8 weeks after surgery
Exclusion criteria
- Microsurgical technique as the primary procedure (i.e. isolated laminotomy or microdiscectomy)
- Having surgery for the primary indication of a spinal deformity
- Having surgery secondary to pseudarthrosis, trauma, infection, or tumor
- Current/history of a primary psychotic or major thought disorder or hospitalization for reasons related to psychosis
- Diagnosis of Alzheimer's disease or another form of dementia
- Traumatic Brain Injury (greater than mild severity)
- History of bipolar disorder or dissociative disorder
- Active substance use disorder (in past month)
- Current Posttraumatic Stress Disorder (PTSD) symptoms (in past month)
Data sourced from ClinicalTrials.gov (NCT04648683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.