Telehealth Mindfulness Program for Low Back Pain

Phase-Based Estimates
1
Effectiveness
1
Safety
Vanderbilt University Medical Center, Nashville, TN
Low Back Pain+4 More
Telehealth Mindfulness Program - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Low Back Pain

Study Summary

This study is evaluating whether a mindfulness intervention may help individuals with chronic low back pain.

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Eligible Conditions

  • Low Back Pain
  • Emergencies
  • Back Pain
  • Pain
  • Chronic Lower Back Pain (CLBP)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Telehealth Mindfulness Program will improve 3 primary outcomes, 6 secondary outcomes, and 5 other outcomes in patients with Low Back Pain. Measurement will happen over the course of 3 months after discharge from the emergency department..

Month 3
Feasibility - Recruitment
Month 3
Feasibility - Retention
Feasibility - Session attendance
Self-reported return visits to the emergency department
Month 3
Five Facet Mindfulness Questionnaire - 15
Pain Catastrophizing Scale
Pain Self-Efficacy Questionnaire
Patient Reported Outcomes Measurement Information System - Anxiety Short Form
Patient Reported Outcomes Measurement Information System - Depression Short Form
Patient Reported Outcomes Measurement Information System - Pain Intensity
Patient Reported Outcomes Measurement Information System - Pain Interference Short Form
Patient Reported Outcomes Measurement Information System - Physical Function Short Form
Patient satisfaction with treatment
Self-reported opioid medication use

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Telehealth Mindfulness Program

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Telehealth Mindfulness Program is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Telehealth Mindfulness Program
Behavioral
Telehealth mindfulness sessions
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months after discharge from emergency department
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months after discharge from emergency department for reporting.

Who is running the study

Principal Investigator
R. C.
Prof. Rogelio Coronado, Research Assistant Professor
Vanderbilt University Medical Center

Closest Location

Vanderbilt University Medical Center - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
rule out a serious spinal pathology The individual has come to the emergency department because they are experiencing an acute worsening of their chronic low back pain show original
The study found that a mindfulness program developed in English was feasible for use in a telehealth setting with English-speaking participants. show original
The person has pain that has lasted for more than three months and occurs on at least half of the days in the past six months. show original
Any person who is 18 years or older is allowed to vote in the election. show original

Patient Q&A Section

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

What is low back pain?

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There is a large proportion of individuals who suffer from non-specific low back pain and those with persistent back pain. Both of them have high levels of psychiatric comorbidities. The psychological comorbidity of back pain should be addressed when treating patients.

Unverified Answer

What causes low back pain?

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Low [back pain](https://www.withpower.com/clinical-trials/back-pain) is one of the leading causes of primary care visits and may be associated with pain intensity, disability and depressive symptoms. More knowledge is needed about back pain from the perspectives of both the patient and the practitioner.

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Can low back pain be cured?

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Even though LBP can be successfully managed, some patients may experience disability due to the chronic LBP. Hence, a cure for LBP has yet to be found. However, there are various approaches that can help with disability and pain, including behavioral therapy and spinal manipulation. There are also clinical trials to explore whether it is possible to cure LBP. Power: can help find an available clinical trial near you.

Unverified Answer

What are common treatments for low back pain?

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A large number of nonoperative therapies, medications, and treatments are used to manage low back pain. There still is no good evidence to show that one treatment is more effective than another.

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How many people get low back pain a year in the United States?

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Each year, 9.2 million Americans are diagnosed with low back pain. The number of people with low back pain has been increasing and is becoming a significant public health issue. Topics for future research should examine the effects of age and sociodemographic (income, education, race/ethnicity, and ethnicity) disparities on low back pain.

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What are the signs of low back pain?

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There are many signs and symptoms of low back and neck pain. Common indications of low back pain include: backache or sciatica, tender to palpation over the sacroiliac joints, or pain in the posterior gluteal region, buttocks or above the anus. Common symptoms include: loss of balance, weakness, loss of coordination, loss of pain awareness (decreased sensitivity and response), decreased and irregular stool frequency and difficulty with urination.

Unverified Answer

Has telehealth mindfulness program proven to be more effective than a placebo?

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A telehealth mindfulness program was effective against depression but not back pain. Further study and more control-group analyses are needed to see if the effectiveness is maintained.

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Is telehealth mindfulness program safe for people?

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The study demonstrates the potential of telehealth interventions for this population, and shows that a mindfulness intervention performed in general practice, without a control group, is capable of producing significant improvements in pain, disability and psychological distress post intervention.

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How does telehealth mindfulness program work?

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The intervention in this study produced benefits to the intervention group. Based on the results we believe that this intervention is recommended to be implemented in other telehealth programs based on the findings from this study.

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What is telehealth mindfulness program?

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Telehealth mindfulness program is efficacious for reducing pain and disability in people with lumbar disc herniation when practiced at least two times a week over four weeks.

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Is telehealth mindfulness program typically used in combination with any other treatments?

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Telehealth mindfulness program is typically used in combination with another treatment. The presence of co-morbidities may limit the use of telehealth mindfulness program. Data from a recent study may have implications for training physicians in managing a variety of chronic conditions.

Unverified Answer

How serious can low back pain be?

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For patients with low [back pain](https://www.withpower.com/clinical-trials/back-pain), the most serious underlying disease were not those with low-grade LBP, whereas pain intensity and the need for medications are significantly lower for patients with LBP.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Low Back Pain by sharing your contact details with the study coordinator.