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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT011569 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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:
Participants will be asked to do the following:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth mindfulness-based intervention (MBI) | Experimental | Eight, weekly telehealth mindfulness sessions delivered one-on-one with mindfulness instructor |
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| Telehealth Education (EDU) | Active Comparator | Eight, weekly post-surgical educational sessions delivered one-on-one with physical therapist |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth mindfulness-based intervention (MBI) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate | Proportion of participants approached who are eligible and enroll in the study | Through enrollment completion, approximately 21 months |
| Participant study retention | Proportion of participants who complete the study (6 month assessment) | Through study completion, approximately 28 months |
| Session attendance | Average percentage of sessions attended | Through 3 months postoperative |
| Intervention Satisfaction | Proportion of participants reporting overall satisfaction levels greater than or equal to 7 out of 10 | 3 months postoperative |
| Home practice completion | Average days practiced out of days assigned practice (MBI group only) | Through 3 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Bothersomeness | 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. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| Pain Interference Short-form 8a |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carrie E Brintz, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 26, 2026 | |
| Reset | Jun 22, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 5, 2024 | Feb 3, 2026 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2026 | Jun 22, 2026 | |||
| Jun 25, 2026 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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.
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| Telehealth Education | Behavioral | 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. |
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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. A lower score indicates lower pain interference, or a better outcome. |
| Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| Overall Pain Intensity 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. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| 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. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| Self-reported opioid medication use | Measured as average number of opioid pills per day (name and dose specified) and converted to morphine equivalent dose. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| Opioid medication collected from the Electronic Medical Record | Opioid medication prescription from patient's electronic medical record to cross-reference self-reported opioid medication use | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| 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") with response options from 1 = never to 5 = always. Lower scores represent lower anxiety, a better outcome | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| 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) with response options from 1 = never to 5 = always. A lower score indicates less depression, a better outcome. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| Sleep Disturbance Short Form 4a | 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). A lower score indicates less sleep disturbance, a better outcome. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| Oswestry Disability Index | 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. Lower scores indicate lower level of disability due to pain, a better outcome. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| Pain Catastrophizing Scale | 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. Lower scores indicate lower pain catastrophizing, a better outcome. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| 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" with response options 0 = not at all to 6 = completely. Higher scores indicate greater pain self-efficacy, a better outcome. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| 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?"), with response options ranging from 0 = never to 4 = very often (2 items reverse-scored). Lower scores indicate lower perceived stress, a better outcome. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| Tampa Scale for Kinesiophobia -13 | 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. Lower scores indicate lower levels of kinesiophobia, a better outcome. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| 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. Response options range from 1 = never to 5 = always (7 items reverse scored). Higher scores indicate higher levels of mindfulness, a better outcome. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| Pain Tolerance | Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the point at which the stimulus (inflated blood pressure cuff) can no longer be tolerated by the participant. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| Pain Threshold | Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the point at which the stimulus (inflated blood pressure cuff) is first experienced as painful by the participant. | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| Temporal Summation of Pain Temporal Summation of Pain | Using a punctate stimuli (von frey hairs of 100g and 180g of force to the finger), the reported highest pain intensity on a scale of 0 to 100 during repeated brief stimuli at a constant intensity | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| Physical Function | 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. Higher scores represent better physical function, a better outcome | Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |