Postoperative Telehealth Mindfulness Intervention After Lumbar Spine Surgery: Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Session attendance
研究概览
简要总结
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:
- Is it feasible and acceptable to deliver the interventions and conduct the study procedures in this patient population?
- 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:
- Complete self-report questionnaires online before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.
- Complete a sensory pain task before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.
- 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).
详细描述
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:
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are masked to the names and specific details of each intervention arm at time of enrollment, and remain masked to the name and details of the intervention arm to which they are not randomized.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking adults
- •Aged 18 years and older
- •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
排除标准
- •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 (e.g. Schizophrenia, brief psychotic disorder, delusional disorder). Medication-induced psychosis is not exclusionary.
- •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)
- •Active suicidal ideation with intent
研究组 & 干预措施
Telehealth mindfulness-based intervention (MBI)
Eight, weekly telehealth mindfulness sessions delivered one-on-one with mindfulness instructor
干预措施: Telehealth mindfulness-based intervention (MBI) (Behavioral)
Telehealth Education (EDU)
Eight, weekly post-surgical educational sessions delivered one-on-one with physical therapist
干预措施: Telehealth Education (Behavioral)
结局指标
主要结局
Session attendance
时间窗: Through 3 months postoperative
Average percentage of sessions attended
Participant study retention
时间窗: Through study completion, approximately 28 months
Proportion of participants who complete the study (6 month assessment)
Intervention Satisfaction
时间窗: 3 months postoperative
Proportion of participants reporting overall satisfaction levels greater than or equal to 7 out of 10
Home practice completion
时间窗: Through 3 months postoperative
Average days practiced out of days assigned practice (MBI group only)
Enrollment Rate
时间窗: Through enrollment completion, approximately 21 months
Proportion of participants approached who are eligible and enroll in the study
Enrollment Rate
时间窗: Preoperatively, from when the potential participant is approached for recruitment until the time at which a potential participant is either eligible and consents to enroll in the study, or is ineligible or declines to enroll in the study, up to 2 weeks.
Proportion of participants approached who are eligible and enroll in the study
Participant Study Retention
时间窗: 6 months postoperative
Proportion of participants who complete the study (6 month assessment)
Session Attendance
时间窗: Through 3 months postoperative
Average proportion of sessions attended out of 8 sessions
Home Practice Completion
时间窗: Through 3 months postoperative
Average days practiced out of days assigned practice (MBI group only)
次要结局
- Back and leg pain intensity(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Self-reported opioid medication use(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Pain Bothersomeness(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Overall Pain Intensity Overall Pain Intensity(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Opioid medication collected from the Electronic Medical Record(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Temporal Summation of Pain Temporal Summation of Pain(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Tampa Scale for Kinesiophobia -13(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Pain Interference Short-form 8a(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Anxiety Short Form 4a(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Depression Short Form 4a(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Five Facet Mindfulness Questionnaire - 15(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Sleep Disturbance Short Form 4a(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Oswestry Disability Index(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Pain Catastrophizing Scale(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Pain Self-efficacy Questionnaire(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Perceived Stress Scale - 4(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Pain Tolerance(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Pain Threshold(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Physical Function(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Back Pain Intensity(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Leg Pain Intensity(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Number of Participants Indicating They Currently Use Opioids(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
- Temporal Summation of Pain(Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative)
研究者
Carrie Brintz
Assistant Professor
Vanderbilt University Medical Center