Opioid Use Clinical Trial
Official title:
Postoperative Telehealth Mindfulness Intervention to Improve Pain-related Outcomes and Reduce Opioid Use After Lumbar Spine Surgery
Verified date | September 2023 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | August 25, 2022 |
Est. primary completion date | August 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt Spine Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | National Center for Complementary and Integrative Health (NCCIH), Osher Center for Integrative Health at Vanderbilt |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility - Study Retention | Percentage of participants enrolled who complete the study | 3 months following lumbar spine surgery | |
Primary | Feasibility - Session Attendance | Percent of sessions attended out of 8 | 3 months following lumbar spine surgery | |
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) | 3 months following lumbar spine surgery | |
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. | 3 months postoperative | |
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. | 3 months postoperative | |
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. | 3 months postoperative | |
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. | 3 months postoperative | |
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. | 3 months postoperative | |
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. | 3 months postoperative | |
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. | 3 months postoperative | |
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. | 3 months postoperative | |
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. | 3 months postoperative | |
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. | 3 months postoperative | |
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. | 3 months postoperative | |
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. | 3 months postoperative | |
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. | 3 months postoperative |
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