Postoperative Telehealth Mindfulness Intervention After Spine Surgery

Opioid Use Clinical Trial

Official title:

Postoperative Telehealth Mindfulness Intervention to Improve Pain-related Outcomes and Reduce Opioid Use After Lumbar Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648683
• Other study ID #: 201486
• Secondary ID: K23AT011569
• Status: Completed
• Phase: N/A
• Start date: December 21, 2021
• Est. completion date: August 25, 2022

Study information

• Verified date: September 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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).
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt Spine Center	Nashville	Tennessee

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

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