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Telehealth Mindfulness for Post-Surgical Pain

N/A
Recruiting
Led By Carrie E Brintz, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to participate in weekly, remote sessions with a study therapist for 8 weeks after surgery
Scheduled for a laminectomy and/or fusion at Vanderbilt Spine Center
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Awards & highlights

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.

Who is the study for?
This trial is for English-speaking adults over 18 who are having their first lumbar spine surgery at Vanderbilt Spine Center due to degenerative conditions like spinal stenosis. They must have had back or leg pain for at least 3 months, be able to attend weekly online sessions post-surgery, and have stable internet access. People with certain psychiatric disorders, substance use issues, severe brain injuries, or those undergoing microsurgical techniques are excluded.Check my eligibility
What is being tested?
The study compares two telehealth interventions after lumbar spine surgery: mindfulness-based intervention (MBI) and education. Participants will complete questionnaires and a sensory pain task before and several times after surgery. Post-surgery, they'll randomly receive either MBI or educational sessions via telehealth once a week for eight weeks to assess pain management and recovery outcomes.See study design
What are the potential side effects?
Since the interventions involve non-invasive behavioral therapy through telehealth sessions focused on mindfulness or education, there are minimal expected side effects. However, participants may experience emotional discomfort when discussing personal experiences related to pain during these sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can attend weekly online sessions with a therapist for 8 weeks after surgery.
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I am scheduled for spine surgery at Vanderbilt Spine Center.
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I have a spine condition like spinal stenosis or spondylosis.
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I have had back or leg pain for at least 3 months.
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I am 18 or older and speak English.
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I am scheduled for my first surgery on the lower back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enrollment Rate
Home practice completion
Intervention Satisfaction
+2 more
Secondary outcome measures
Anxiety Short Form 4a
Back and leg pain intensity
Depression Short Form 4a
+16 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Telehealth mindfulness-based intervention (MBI)Experimental Treatment1 Intervention
Eight, weekly telehealth mindfulness sessions delivered one-on-one with mindfulness instructor
Group II: Telehealth Education (EDU)Active Control1 Intervention
Eight, weekly post-surgical educational sessions delivered one-on-one with physical therapist

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
853 Previous Clinical Trials
670,996 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
829 Previous Clinical Trials
668,857 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

Media Library

Telehealth Education Clinical Trial Eligibility Overview. Trial Name: NCT05698914 — N/A
Lumbar Spine Surgery Research Study Groups: Telehealth mindfulness-based intervention (MBI), Telehealth Education (EDU)
Lumbar Spine Surgery Clinical Trial 2023: Telehealth Education Highlights & Side Effects. Trial Name: NCT05698914 — N/A
Telehealth Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT05698914 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity of this research project?

"Confirmatively, the details stored on clinicaltrials.gov 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."

Answered by AI

Are new participants still being accepted for this experiment?

"According to the clinicaltrials.gov 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."

Answered by AI

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."

Answered by AI
~35 spots leftby Apr 2025