Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
NCT Number: NCT05698914
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37232, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Through enrollment completion, approximately 21 months
Proportion of participants approached who are eligible and enroll in the study
Time frame: Through study completion, approximately 28 months
Proportion of participants who complete the study (6 month assessment)
Time frame: Through 3 months postoperative
Average percentage of sessions attended
Time frame: 3 months postoperative
Proportion of participants reporting overall satisfaction levels greater than or equal to 7 out of 10
Time frame: Through 3 months postoperative
Average days practiced out of days assigned practice (MBI group only)
Time frame: 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.
Time frame: 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. A lower score indicates lower pain interference, or a better outcome.
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 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.
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 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.
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Measured as average number of opioid pills per day (name and dose specified) and converted to morphine equivalent dose.
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Opioid medication prescription from patient's electronic medical record to cross-reference self-reported opioid medication use
Time frame: 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. Lower scores represent lower anxiety, a better outcome
Time frame: 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. A lower score indicates less depression, a better outcome.
Time frame: 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). A lower score indicates less sleep disturbance, a better outcome.
Time frame: 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. Lower scores indicate lower level of disability due to pain, a better outcome.
Time frame: 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. Lower scores indicate lower pain catastrophizing, a better outcome.
Time frame: 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. Higher scores indicate greater pain self-efficacy, a better outcome.
Time frame: 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). Lower scores indicate lower perceived stress, a better outcome.
Time frame: 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. Lower scores indicate lower levels of kinesiophobia, a better outcome.
Time frame: 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). Higher scores indicate higher levels of mindfulness, a better outcome.
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
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.
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
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.
Time frame: 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 reported highest pain intensity on a scale of 0 to 100 during repeated brief stimuli at a constant intensity
Time frame: 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. Higher scores represent better physical function, a better outcome
Vanderbilt University Medical Center
Other
Postoperative Telehealth Mindfulness Intervention After Lumbar Spine Surgery: Pilot Randomized Controlled Trial
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