Telehealth mindfulness-based intervention (MBI) for Lumbar Spine Surgery

Phase-Based Progress Estimates
Vanderbilt University Medical Center, Nashville, TNLumbar Spine Surgery+2 MoreTelehealth mindfulness-based intervention (MBI) - Behavioral
All Sexes
What conditions do you have?

Study Summary

This trial will compare two behavioral interventions to see if they help people recovering from lumbar spinal surgery with pain-related, functional, opioid use, and psychosocial outcomes. Participants will be randomly assigned and attend 8, weekly sessions with a coach over telehealth.

Eligible Conditions
  • Lumbar Spine Surgery
  • Chronic Lower Back Pain
  • Post-Surgical Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 18 Secondary · Reporting Duration: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

3 months postoperative
Intervention Satisfaction
Month 6
Anxiety Short Form 4a
Back and leg pain intensity
Depression Short Form 4a
Five Facet Mindfulness Questionnaire - 15
Opioid medication collected from the Electronic Medical Record
Oswestry Disability Index
Overall Pain Intensity Overall Pain Intensity
Pain Bothersomeness
Pain Catastrophizing Scale
Pain Interference Short-form 8a
Pain Self-efficacy Questionnaire
Pain Threshold
Pain Tolerance
Perceived Stress Scale - 4
Self-reported opioid medication use
Sleep Disturbance Short Form 4a
Tampa Scale for Kinesiophobia -13
Temporal Summation of Pain Temporal Summation of Pain
Through 3 months postoperative
Home practice completion
Session attendance
Month 21
Enrollment Rate
Month 28
Participant study retention

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Telehealth Education (EDU)
1 of 2
Telehealth mindfulness-based intervention (MBI)
1 of 2

Active Control

Experimental Treatment

72 Total Participants · 2 Treatment Groups

Primary Treatment: Telehealth mindfulness-based intervention (MBI) · No Placebo Group · N/A

Telehealth mindfulness-based intervention (MBI)
Experimental Group · 1 Intervention: Telehealth mindfulness-based intervention (MBI) · Intervention Types: Behavioral
Telehealth Education (EDU)
ActiveComparator Group · 1 Intervention: Telehealth Education · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
784 Previous Clinical Trials
599,168 Total Patients Enrolled
1 Trials studying Lumbar Spine Surgery
10 Patients Enrolled for Lumbar Spine Surgery
National Center for Complementary and Integrative Health (NCCIH)NIH
787 Previous Clinical Trials
657,387 Total Patients Enrolled
1 Trials studying Lumbar Spine Surgery
10 Patients Enrolled for Lumbar Spine Surgery
Carrie E Brintz, PhDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Lumbar Spine Surgery
10 Patients Enrolled for Lumbar Spine Surgery

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been experiencing lower back and/or leg pain for at least 3 months.
You need to have a reliable internet connection.
You have an existing condition affecting your spine, like narrowing of the spinal canal or slipped vertebrae.

Frequently Asked Questions

What is the current capacity of this research project?

"Confirmatively, the details stored on indicate that this research trial is actively recruiting participants. Originally posted on February 22nd 2023 and last updated March 9th 2023, 72 patients are being sought from a single location." - Anonymous Online Contributor

Unverified Answer

Are new participants still being accepted for this experiment?

"According to the listing, this medical trial is actively recruiting patients at present. It was initially made available on February 22nd 2023 and has been recently revised as of March 9th 2023." - Anonymous Online Contributor

Unverified Answer

What are the aims of this research endeavor?

"The purpose of this trial, monitored over a 3 month period post-surgery, is to evaluate its enrollment rate. Secondary objectives encompass Pain Interference Short-form 8a from the Patient Reported Outcomes Measurement Information System with response options ranging from 'not at all' to 'very much', Overall Pain Intensity as rated on a 0-10 scale and Back & Leg Pain Intensity measured across two items both scored on a 0-10 scale when medication has worn off. A lower score in any of these measures denotes better outcomes for patients." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.