What side effects are associated with this type of intervention?

Mindfulness-based interventions, such as those focusing on awareness and stress reduction, are generally well-tolerated with minimal side effects. Some individuals may experience temporary discomfort or emotional distress as they become more aware of their thoughts and feelings. Educational interventions, which provide information and knowledge, typically have no direct side effects but may lead to frustration or anxiety if the information is overwhelming or not well understood. Both interventions aim to improve coping skills and overall well-being, making them suitable adjuncts to traditional postoperative care.

What prior FDA approvals exist?

The FDA primarily approves pharmacological treatments for conditions related to lumbar spine surgery, such as pain management medications. However, non-pharmacological treatments like mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) are commonly used in clinical practice to manage pain and improve functional outcomes. These behavioral interventions focus on increasing awareness, reducing stress, and providing education to help patients cope with pain and enhance recovery. While these therapies are not FDA-approved in the same way as drugs, they are supported by clinical evidence and integrated into comprehensive pain management programs.

What other types of research exist?

Promising novel alternatives for lumbar spine surgery patients include Cognitive Behavioral Therapy (CBT), which has shown efficacy in managing chronic pain and improving psychological outcomes. Additionally, movement-based interventions with a mind-body component, such as Tai Chi and yoga, are beneficial for improving function and managing pain. Combining these with psychological interventions like Mindfulness-Based Stress Reduction (MBSR) or biofeedback can also be effective.

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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

Scheduled for a laminectomy and/or fusion at Vanderbilt Spine Center

Radiographic evidence of a degenerative condition including but not limited to spinal stenosis, spondylosis with or without myelopathy, and spondylolisthesis

Must not have

Having surgery for the primary indication of a spinal deformity

Having surgery secondary to pseudarthrosis, trauma, infection, or tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two support methods for patients after spine surgery. It targets patients with degenerative spine conditions to see if these methods help with pain and recovery. Mindfulness helps manage pain by focusing on the present, while education helps by providing useful information.

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having surgery to correct a spinal deformity.

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I need surgery due to a false joint, injury, infection, or tumor.

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My surgery will be done using a microscope.

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I have been diagnosed with Alzheimer's disease or another type of dementia.

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I have never been hospitalized for a major thought disorder like schizophrenia.

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I have had a serious brain injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enrollment Rate

Home practice completion

Intervention Satisfaction

+2 more

Secondary study objectives

Anxiety Short Form 4a

Back and leg pain intensity

Depression Short Form 4a

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mindfulness-based interventions for lumbar spine surgery patients work by enhancing awareness and reducing stress, which can help manage pain and improve psychological well-being. Educational interventions provide patients with crucial information about their condition and recovery, empowering them to manage their health more effectively. Both approaches aim to improve functional outcomes and reduce reliance on medications by addressing the physical and psychological aspects of recovery, which is essential for comprehensive post-surgical rehabilitation.

Back school or brain school for patients undergoing surgery for lumbar radiculopathy? Protocol for a randomised, controlled trial.Daily exercises and education for preventing low back pain in children: cluster randomized controlled trial.