Chronic Low-back Pain, Lumbar Spine Surgery, Opioid Use, Postsurgical Pain
Conditions
Keywords
Mindfulness, Telehealth, Mindfulness-based intervention
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).
Interventions
BEHAVIORALIndividual telehealth mindfulness
Participants who enroll and complete lumbar spine surgery will participate in a one-on-one telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 75 minutes each (except the first session which lasts 90 minutes).
BEHAVIORALGroup telehealth mindfulness
Participants who enroll and complete lumbar spine surgery will participate in a group-delivered telehealth (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 90 minutes each.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Vanderbilt University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm, nonrandomized, repeated measures design
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Study Retention | 3 months following lumbar spine surgery | Percentage of participants enrolled who complete the study |
| Feasibility - Session Attendance | 3 months following lumbar spine surgery | Percent of sessions attended out of 8 |
| Acceptability - Satisfaction With Intervention | 3 months following lumbar spine surgery | Nine items assessing satisfaction with the postsurgical telehealth mindfulness intervention (sum of item scores; higher scores indicate higher satisfaction; scores can range from 7 to 55) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Back and Leg Pain Intensity | 3 months postoperative | 2 items assessing back and 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. |
| Self-reported Opioid Medication Use | 3 months postoperative | Measured as average number of opioid pills per day (name and dose specified) and converted to morphine equivalent dose. |
| Anxiety Short Form 4a | 3 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). Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. Lower scores represent lower anxiety, a better outcome. |
| Depression Short Form 4a | 3 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). Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. A lower score indicates less depression, a better outcome. |
| Oswestry Disability Index | 3 months postoperative | Assesses impact of pain on level of functioning in 10 areas (e.g. walking, sleep, social life). Scores range from 0-100. Lower scores indicate lower level of disability due to pain, a better outcome. |
| Pain Bothersomeness | 3 months postoperative | One item assessing how bothersome pain has been in the past 7 days from not at all = 0 to extremely = 4. A higher scores indicates higher pain bothersomeness. |
| Pain Self-efficacy Questionnaire | 3 months postoperative | 10 items assessing confidence in ability to do certain things despite pain (e.g. I can enjoy things, despite the pain. Scores range from 0 to 60. Higher scores indicate greater pain self-efficacy, a better outcome. |
| Perceived Stress Scale - 4 | 3 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?). Scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome. |
| Tampa Scale for Kinesiophobia -13 | 3 months postoperative | 13 items assessing fear of movement (e.g. I'm afraid that I might injure myself if I exercise. Scores range from 13-52. Lower scores indicate lower levels of kinesiophobia, a better outcome. |
| Five Facet Mindfulness Questionnaire - 15 | 3 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. Scores range from 1 to 5 (calculated by taking the average of the total sum score). Higher scores indicate higher levels of mindfulness, a better outcome. |
| Pain Catastrophizing Scale | 3 months postoperative | 13 items assessing thoughts and feelings when in pain (e.g. I become afraid that the pain will get worse. Scores range from 0-52. Lower scores indicate lower pain catastrophizing, a better outcome. |
| Pain Interference Short-form 4a | 3 months postoperative | Pain Interference short-form 4a from the Patient Reported Outcomes Measurement Information System scale. Measures interference of pain in day to day activities, work around the home, participation in social activities, and household chores over the past 7 days. Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. A lower T-score indicates lower pain interference, or a better outcome. |
| Overall Pain Intensity | 3 months postoperative | 1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with average pain intensity over the past 7 days rated on 0-10 scale with lower values indicating less pain, or better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Individual Telehealth Mindfulness Telehealth mindfulness sessions delivered one-on-one with mindfulness therapist
Individual telehealth mindfulness: Participants who enroll and complete lumbar spine surgery will participate in a one-on-one telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 75 minutes each (except the first session which lasts 90 minutes). | 10 |
| Group Telehealth Mindfulness Telehealth mindfulness sessions delivered in a small-group format with mindfulness therapist
Group telehealth mindfulness: Participants who enroll and complete lumbar spine surgery will participate in a group-delivered telehealth (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 90 minutes each. | 0 |
| Total | 10 |
Baseline characteristics
| Characteristic | Total | Individual Telehealth Mindfulness |
|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 16.6 | 62.3 years STANDARD_DEVIATION 16.6 |
| Education High School diploma or GED | 3 Participants | 3 Participants |
| Education Post-college | 2 Participants | 2 Participants |
| Education Two- or Four-year college degree | 3 Participants | 3 Participants |
| Education Unknown or not reported | 2 Participants | 2 Participants |
| Employment Employed and currently working | 2 Participants | 2 Participants |
| Employment Employed but not working (short-term disability or leave) | 2 Participants | 2 Participants |
| Employment Unemployed | 3 Participants | 3 Participants |
| Employment Unknown or not reported | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Acceptability - Satisfaction With Intervention
Nine items assessing satisfaction with the postsurgical telehealth mindfulness intervention (sum of item scores; higher scores indicate higher satisfaction; scores can range from 7 to 55)
Time frame: 3 months following lumbar spine surgery
Population: Group arm discontinued
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Acceptability - Satisfaction With Intervention | 53.0 score on a scale | Standard Deviation 2 |
Primary
Feasibility - Session Attendance
Percent of sessions attended out of 8
Time frame: 3 months following lumbar spine surgery
Population: 5 participants started intervention. Remaining 5 participants withdrew prior to starting intervention.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Individual Telehealth Mindfulness | Feasibility - Session Attendance | 8 sessions | 3 Participants |
| Individual Telehealth Mindfulness | Feasibility - Session Attendance | 3 sessions | 1 Participants |
| Individual Telehealth Mindfulness | Feasibility - Session Attendance | 1 session | 1 Participants |
Primary
Feasibility - Study Retention
Percentage of participants enrolled who complete the study
Time frame: 3 months following lumbar spine surgery
Population: Group arm discontinued
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individual Telehealth Mindfulness | Feasibility - Study Retention | 3 Participants |
Secondary
Anxiety Short Form 4a
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). Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. Lower scores represent lower anxiety, a better outcome.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Anxiety Short Form 4a | 40.3 T-score | Standard Deviation 0 |
Secondary
Back and Leg Pain Intensity
2 items assessing back and 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.
Time frame: 3 months postoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Telehealth Mindfulness | Back and Leg Pain Intensity | Back pain | 0.7 units on a scale | Standard Deviation 0.6 |
| Individual Telehealth Mindfulness | Back and Leg Pain Intensity | Leg Pain | 0.3 units on a scale | Standard Deviation 0.6 |
Secondary
Depression Short Form 4a
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). Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. A lower score indicates less depression, a better outcome.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Depression Short Form 4a | 43.6 T-score | Standard Deviation 4.6 |
Secondary
Five Facet Mindfulness Questionnaire - 15
15 items assessing 5 facets of mindfulness, including observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Scores range from 1 to 5 (calculated by taking the average of the total sum score). Higher scores indicate higher levels of mindfulness, a better outcome.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Five Facet Mindfulness Questionnaire - 15 | 3.8 score on a scale | Standard Deviation 0.5 |
Secondary
Oswestry Disability Index
Assesses impact of pain on level of functioning in 10 areas (e.g. walking, sleep, social life). Scores range from 0-100. Lower scores indicate lower level of disability due to pain, a better outcome.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Oswestry Disability Index | 18.0 score on a scale | Standard Deviation 19.1 |
Secondary
Overall Pain Intensity
1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with average pain intensity over the past 7 days rated on 0-10 scale with lower values indicating less pain, or better outcome.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Overall Pain Intensity | 0.7 units on a scale | Standard Deviation 0.6 |
Secondary
Pain Bothersomeness
One item assessing how bothersome pain has been in the past 7 days from not at all = 0 to extremely = 4. A higher scores indicates higher pain bothersomeness.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Pain Bothersomeness | 0.3 units on a scale | Standard Deviation 0.6 |
Secondary
Pain Catastrophizing Scale
13 items assessing thoughts and feelings when in pain (e.g. I become afraid that the pain will get worse. Scores range from 0-52. Lower scores indicate lower pain catastrophizing, a better outcome.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Pain Catastrophizing Scale | 1.3 score on a scale | Standard Deviation 2.3 |
Secondary
Pain Interference Short-form 4a
Pain Interference short-form 4a from the Patient Reported Outcomes Measurement Information System scale. Measures interference of pain in day to day activities, work around the home, participation in social activities, and household chores over the past 7 days. Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. A lower T-score indicates lower pain interference, or a better outcome.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Pain Interference Short-form 4a | 46.3 T-score | Standard Deviation 8.1 |
Secondary
Pain Self-efficacy Questionnaire
10 items assessing confidence in ability to do certain things despite pain (e.g. I can enjoy things, despite the pain. Scores range from 0 to 60. Higher scores indicate greater pain self-efficacy, a better outcome.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Pain Self-efficacy Questionnaire | 52.7 score on a scale | Standard Deviation 12.7 |
Secondary
Perceived Stress Scale - 4
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?). Scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Perceived Stress Scale - 4 | 4.0 score on a scale | Standard Deviation 4 |
Secondary
Self-reported Opioid Medication Use
Measured as average number of opioid pills per day (name and dose specified) and converted to morphine equivalent dose.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Self-reported Opioid Medication Use | 0.0 milligrams of morphine equivalents | Standard Deviation 0 |
Secondary
Tampa Scale for Kinesiophobia -13
13 items assessing fear of movement (e.g. I'm afraid that I might injure myself if I exercise. Scores range from 13-52. Lower scores indicate lower levels of kinesiophobia, a better outcome.
Time frame: 3 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Telehealth Mindfulness | Tampa Scale for Kinesiophobia -13 | 24.5 score on a scale | Standard Deviation 8.4 |