Clinical trial NCT05698914: Telehealth Mindfulness After Spine Surgery
Official title: Postoperative Telehealth Mindfulness Intervention After Lumbar Spine Surgery: Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lumbar Spine Surgery
Chronic Low-back Pain
Postsurgical Pain
Keywords: Mindfulness
Telehealth
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-01-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

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).

Detailed description: This is a pilot randomized clinical trial comparing a telehealth mindfulness-based intervention (MBI) with a telehealth education intervention (EDU) for patients recovering from spine surgery. The procedures will be as follows:

1. Enroll patients prior to lumbar spine surgery for a degenerative spine condition at the Vanderbilt Comprehensive Spine Center. Recruitment, enrollment, and screening will occur at a routine preoperative clinic visit or over the phone.
2. Two weeks after enrolled participants complete surgery, they will be randomized in a 3:2 ratio to either MBI or EDU condition, respectively. Randomization will be stratified by chronic preoperative opioid use (yes/no). The randomization assignments will remain concealed from all study personnel until the time of randomization. The outcome assessor and surgical providers will remain blinded to participant study condition.
3. Within four weeks of surgery, participants will begin the assigned intervention. The interventions will consist of meeting with an interventionist for eight, weekly one-on-one telehealth MBI sessions over an online telehealth platform. MBI sessions will led by a clinical psychologist and will be 75 minutes long (90 minutes for the first session). EDU sessions will be led by a physical therapist and will be 30 minutes long. Sessions will be audio recorded and monitored for fidelity.

3) Participants will complete self-report assessments online prior to surgery, two weeks after surgery (pre-intervention), three months after surgery (post-intervention) and 6 months after surgery.

4) Participants will complete quantitative sensory testing assessments of pain tolerance, pain threshold, and temporal summation of pain prior to surgery, two weeks after surgery, three months after surgery, and 6 months after surgery.

Eligibility criteria: 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

Primary outcomes:
measure: Enrollment Rate
timeFrame: Through enrollment completion, approximately 21 months
measure: Participant study retention
timeFrame: Through study completion, approximately 28 months
measure: Session attendance
timeFrame: Through 3 months postoperative
measure: Intervention Satisfaction
timeFrame: 3 months postoperative
measure: Home practice completion
timeFrame: Through 3 months postoperative
Secondary outcomes:
measure: Pain Bothersomeness
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Pain Interference Short-form 8a
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Overall Pain Intensity Overall Pain Intensity
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Back and leg pain intensity
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Self-reported opioid medication use
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Opioid medication collected from the Electronic Medical Record
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Anxiety Short Form 4a
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Depression Short Form 4a
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Sleep Disturbance Short Form 4a
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Oswestry Disability Index
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Pain Catastrophizing Scale
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Pain Self-efficacy Questionnaire
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Perceived Stress Scale - 4
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Tampa Scale for Kinesiophobia -13
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Five Facet Mindfulness Questionnaire - 15
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Pain Tolerance
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Pain Threshold
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Temporal Summation of Pain Temporal Summation of Pain
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
measure: Physical Function
timeFrame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Carrie E Brintz, PhD
role: PRINCIPAL_INVESTIGATOR
References: