Chronic Low-back Pain, Lumbar Spine Surgery, Postsurgical Pain
Conditions
Keywords
Mindfulness, Telehealth
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.
Interventions
BEHAVIORALTelehealth mindfulness-based intervention (MBI)
The telehealth MBI is adapted from Mindfulness-based cognitive therapy for chronic pain and consists of eight, weekly 75-minute individual sessions (90 minutes allotted for the first session) with a mindfulness interventionist delivering the intervention over telehealth (online with audio and video camera) in addition to the patient receiving their usual postsurgical care. Participants will begin the intervention after completing the 2-week postoperative assessment and within 4 weeks after surgery. Participants will be asked to practice skills between sessions approximately 20-40 minutes per day.
BEHAVIORALTelehealth Education
Participants will receive a written educational booklet at the time of randomization (within 2-4 weeks after surgery) and 8, weekly telehealth sessions lasting 30 minutes in addition to usual postsurgical care. The educational materials are reviewed individually with the participant during weekly telehealth sessions (online with audio and video camera) by a physical therapist.
Sponsors
Vanderbilt University Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Study Retention | 6 months postoperative | Proportion of participants who complete the study (6 month assessment) |
| Session Attendance | Through 3 months postoperative | Average proportion of sessions attended out of 8 sessions |
| Intervention Satisfaction | 3 months postoperative | Proportion of participants reporting overall satisfaction levels greater than or equal to 7 out of 10 |
| Home Practice Completion | Through 3 months postoperative | Average days practiced out of days assigned practice (MBI group only) |
| Enrollment Rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing Scale | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | 13 items assessing thoughts and feelings when in pain (e.g. "I become afraid that the pain will get worse" with response options ranging from 0 = never to 4 = all the time. Total scores range from 0 to 52 units on the scale. Lower scores indicate lower pain catastrophizing, a better outcome. |
| Pain Self-efficacy Questionnaire | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | 10 items assessing confidence in ability to do certain things despite pain (e.g. "I can enjoy things, despite the pain" with response options 0 = not at all to 6 = completely. Total scores range from 0 to 60 units on the scale. Higher scores indicate greater pain self-efficacy, a better outcome. |
| Perceived Stress Scale - 4 | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | 4 items assessing perceived level of stress in the past month (e.g. "In the last month, how often have you felt that you were unable to control the important things in your life?"), with response options ranging from 0 = never to 4 = very often (2 items reverse-scored). Total scores range from 0 to 16 units on the scale. Lower scores indicate lower perceived stress, a better outcome. |
| Tampa Scale for Kinesiophobia -13 | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | 13 items assessing fear of movement (e.g. "I'm afraid that I might injure myself if I exercise" with response options ranging from 1 = strongly disagree to 4 = strongly agree. Total scores range from 13 to 52 units on the scale. Lower scores indicate lower levels of kinesiophobia, a better outcome. |
| Five Facet Mindfulness Questionnaire - 15 | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | 15 items assessing 5 facets of mindfulness, including observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Response options range from 1 = never to 5 = always (7 items reverse scored). Total scores are an average of the sum of all items, ranging from 1 to 5 units on the scale. Higher scores indicate higher levels of mindfulness, a better outcome. |
| Number of Participants Indicating They Currently Use Opioids | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | Participants were asked in one item "Are you currently taking an opioid medication?" Response options included "Yes" or "No." A response of Yes counted as 1 and No counted as 0 when calculating total frequency of participants reporting current opioid use. |
| Pain Tolerance | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | The duration of time participants tolerated an inflated blood pressure cuff: Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the time in seconds at which the participant indicated they could no longer tolerate the stimulus (inflated blood pressure cuff). Scores could range from 0 seconds to 300 seconds, as the task was discontinued at 300 seconds if reached prior to the participant indicating to stop the task. |
| Pain Interference Short-form 8a | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | Pain Interference short-form 8a from the Patient Reported Outcomes Measurement Information System scale. Measures interference of pain over the past 7 days. Consists of 8 items with response options from 1 = not at all to 5 = very much. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates lower pain interference, or a better outcome. |
| Pain Bothersomeness | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | One item assessing how bothersome pain has been in the past 7 days from 0 = not at all to 4 = extremely. A lower scores indicates lower pain bothersomeness. |
| Back Pain Intensity | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | 1 item assessing back pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome. |
| Leg Pain Intensity | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | 1 item assessing leg pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome. |
| Pain Threshold | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | Duration at which participants indicate a stimulus is experienced as painful: Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the point in seconds at which the stimulus (inflated blood pressure cuff) is first reported by the participant as painful. Scores could range from 0 seconds to 300 seconds, as the task was discontinued at 300 seconds if participants did not yet indicate that the stimulus was painful. |
| Anxiety Short Form 4a | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing anxiety symptoms in the past 7 days (e.g. "I felt fearful") with response options from 1 = never to 5 = always. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. Lower scores represent lower anxiety, a better outcome |
| Temporal Summation of Pain | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | Using a punctate stimuli (von frey hairs of 100g and 180g of force to the finger), the difference between reported pain intensity during a single prick and the reported highest pain intensity during repeated brief pricks at a constant intensity. Pain intensity was measured on a scale of 0 to 100. The difference score was calculated by subtracting the pain intensity with single prick from the pain intensity with repeated pricks and could range from 0 to 100 units of difference on the pain intensity scale. Lower values are a more favorable outcome. |
| Physical Function | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | Physical Function short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing physical function in the past 7 days (e.g. "Are you able to do chores such as vacuuming or yard work?") with response options from 1 = Unable to do to 5 = Without any difficulty. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. Higher scores represent better physical function, a better outcome |
| Depression Short Form 4a | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing depressive symptoms over the past 7 days (e.g. "I felt worthless) with response options from 1 = never to 5 = always. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates less depression, a better outcome. |
| Sleep Disturbance Short Form 4a | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing sleep disturbance over the past 7 days (e.g. "I had difficulty falling asleep) with response options from 1 = not at all to 5 = very much (1 item reverse-scored). The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates less sleep disturbance, a better outcome. |
| Oswestry Disability Index | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative | Assesses impact of pain on level of functioning in 10 areas (e.g. walking, sleep, social life) with 10 items with response options with scores 0 to 5. Total scores are calculated as a percentage, ranging from 0% to 100%. Lower scores indicate a lower level of disability due to pain, a better outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarrie E Brintz, PhD
Vanderbilt University Medical Center
Participant flow
Pre-assignment details
Participants were enrolled prior to surgery but randomized after surgery was completed. 7 out of 67 enrolled participants were not randomized to a study arm either because they did not have surgery or they chose to withdraw prior to randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.9 Years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 53 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 35 | 0 / 25 | 1 / 7 |
| other Total, other adverse events | 5 / 35 | 4 / 25 | 0 / 7 |
| serious Total, serious adverse events | 4 / 35 | 2 / 25 | 0 / 7 |
Outcome results
None listed