Clinical trial NCT04648683: Postoperative Telehealth Mindfulness Intervention After Spine Surgery
Official title: Postoperative Telehealth Mindfulness Intervention to Improve Pain-related Outcomes and Reduce Opioid Use After Lumbar Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Postsurgical Pain
Opioid Use
Lumbar Spine Surgery
Keywords: Mindfulness
Telehealth
Mindfulness-based intervention
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-12-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, nonrandomized, repeated measures design
Primary purpose: TREATMENT

Brief 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.

Detailed description: We will conduct a two-arm, nonrandomized, mixed-methods trial to refine a telehealth mindfulness-based intervention (MBI) for patients recovering from spine surgery. The procedures will be as follows:

1. Recruit, consent and enroll up to 26 patients over a period of 8 months who are planning to have their first lumbar spine surgery for a degenerative spine condition at the Vanderbilt Comprehensive Spine Center. Recruitment will occur at a routine preoperative clinic visit or over the phone, with the spine surgeon's permission to approach the patient.
2. Two weeks after enrolled patients complete surgery, they will meet with an interventionist for eight, weekly one-on-one or group-delivered telehealth MBI sessions over a Zoom online telehealth platform. Sessions will be 75 minutes long (90 minutes for the first session). Sessions will be audio recorded and the interventionists will be supervised weekly.
3. Participants will complete self-report assessments prior to surgery, two weeks after surgery (pre-intervention) and three months after surgery (post-intervention).
4. After completing the intervention, participants will complete an intervention satisfaction survey and an audio-recorded 30-minute semi-structured interview over the phone to provide feedback regarding their experience with the intervention components and relevance to their postoperative recovery.
5. We will code and analyze interview data continuously (every 2-4 interviews) until we reach data saturation and then integrate results from interviews and self-report surveys to determine relevant intervention adaptations, constructing a refined intervention protocol for pilot testing in a randomized controlled trial. We anticipate needing approximately 13-20 participants to complete interviews to reach data saturation (i.e. no new, relevant information obtained from interviews).

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility - Study Retention
timeFrame: 3 months following lumbar spine surgery
measure: Feasibility - Session Attendance
timeFrame: 3 months following lumbar spine surgery
measure: Acceptability - Satisfaction With Intervention
timeFrame: 3 months following lumbar spine surgery
Secondary outcomes:
measure: Pain Bothersomeness
timeFrame: 3 months postoperative
measure: Pain Interference Short-form 4a
timeFrame: 3 months postoperative
measure: Overall Pain Intensity
timeFrame: 3 months postoperative
measure: Back and Leg Pain Intensity
timeFrame: 3 months postoperative
measure: Self-reported Opioid Medication Use
timeFrame: 3 months postoperative
measure: Anxiety Short Form 4a
timeFrame: 3 months postoperative
measure: Depression Short Form 4a
timeFrame: 3 months postoperative
measure: Oswestry Disability Index
timeFrame: 3 months postoperative
measure: Pain Catastrophizing Scale
timeFrame: 3 months postoperative
measure: Pain Self-efficacy Questionnaire
timeFrame: 3 months postoperative
measure: Perceived Stress Scale - 4
timeFrame: 3 months postoperative
measure: Tampa Scale for Kinesiophobia -13
timeFrame: 3 months postoperative
measure: Five Facet Mindfulness Questionnaire - 15
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Spine Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Carrie E Brintz, PhD
role: PRINCIPAL_INVESTIGATOR
References: