Telehealth Mindfulness After Spine Surgery

Chronic Low-back Pain Clinical Trial

Official title:

Postoperative Telehealth Mindfulness Intervention After Lumbar Spine Surgery: Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698914
• Other study ID #: 221711
• Secondary ID: K23AT011569
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Clinical Research Coordinator
• Phone: 615-421-8336
• Email: mindful[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Low-back Pain
• Low Back Pain
• Lumbar Spine Surgery
• Pain, Postoperative
• Postsurgical Pain

Intervention

Behavioral:
• Telehealth 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.
• Telehealth 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment Rate	Proportion of participants approached who are eligible and enroll in the study	Through enrollment completion, approximately 21 months
Primary	Participant study retention	Proportion of participants who complete the study (6 month assessment)	Through study completion, approximately 28 months
Primary	Session attendance	Average percentage of sessions attended	Through 3 months postoperative
Primary	Intervention Satisfaction	Proportion of participants reporting overall satisfaction levels greater than or equal to 7 out of 10	3 months postoperative
Primary	Home practice completion	Average days practiced out of days assigned practice (MBI group only)	Through 3 months postoperative
Secondary	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
Secondary	Pain Interference Short-form 8a	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
Secondary	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
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.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 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.	Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Secondary	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
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") 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
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) 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
Secondary	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
Secondary	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
Secondary	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
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" 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
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?"), 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
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" 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
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. 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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