Digital program for Low Back Pain

Phase-Based Estimates
1
Effectiveness
1
Safety
Emory Orthopaedic and Spine Center (Atlanta, Ga), Atlanta, GA
Low Back Pain+2 More
Digital program - Device
Eligibility
18+
All Sexes
Eligible conditions
Low Back Pain

Study Summary

This study is evaluating whether a digital care program is more effective than conventional physical therapy for chronic low back pain.

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Eligible Conditions

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

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Digital program will improve 1 primary outcome and 12 secondary outcomes in patients with Low Back Pain. Measurement will happen over the course of Between enrollment and 8 weeks.

Week 8
Patient satisfaction with intervention
Week 8
Oswestry Disability Index score (ODI)
Week 8
Anxiety
Depression
Fear avoidance beliefs (FABQ-PA)
Interest in undergoing surgery
Medication consumption
Pain level
Physical activity levels
Work productivity and activity impairment (WPAI)
Week 8
Retention rate
Treatment intensity
Week 8
Adherence

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Conventional rehabilitation at an outpatient clinic
Digital Rehabilitation

This trial requires 144 total participants across 2 different treatment groups

This trial involves 2 different treatments. Digital 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.

Digital Rehabilitation
Device
Home-based rehabilitation with a digital biofeedback system
Conventional rehabilitation at an outpatient clinic
Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 4 weeks and 8 weeks after initiation of rehabilitation program
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 4 weeks and 8 weeks after initiation of rehabilitation program for reporting.

Closest Location

Emory Orthopaedic and Spine Center (Atlanta, Ga) - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
were studied The study looked at subjects aged between 18 and 80 years old. show original
, is a key criterion for classifying individuals as having chronic low back pain (CLBP) If someone experiences low back pain on and off for at least six weeks, and it's been present for at least 50% of the time in the past six months, then they would be classified as having chronic low back pain. show original
The ability to understand complex motor tasks is necessary for normal development 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.

Can low back pain be cured?

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There is a lack of high quality trials investigating the usefulness of different strategies in the management of low back pain. However, due to the potential benefits of some interventions, further studies investigating and comparing the efficacy of these interventions are needed.

Unverified Answer

What is low back pain?

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There are two essential components to low [back pain](https://www.withpower.com/clinical-trials/back-pain): 1) pain (ie, nociceptive signals), and 2) dysfunction or impairment in the nerves supplying sensation to the lower back. The pain (ie, nociceptive) originates from various locations in the LBP-affected spine.\n

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

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Nearly 4.7 million Americans will experience low back pain, causing them to spend $27.7 billion a year in healthcare expenses. About 16.5 million will consult a doctor about it, and 5.6 million will seek help from a chiropractor. Nearly 1.4 million of those will have to seek treatment more than once, and 0.7 million will go to hospital or other care more than 2 times. To address this large and growing problem, we recommend that clinicians be aware of this disorder in their patients.

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What are common treatments for low back pain?

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Treatment is usually conservative, focusing on education and reassurance about normal activity. The majority of low [back pain](https://www.withpower.com/clinical-trials/back-pain) patients can expect improvement over a minimum of 2 to 3 weeks. In some cases, low back surgery may be indicated. Pain can be exacerbated by physical activity. Although exercise, relaxation, and massage can reduce discomfort in the short term, they do not necessarily alleviate pain permanently.

Unverified Answer

What are the signs of low back pain?

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[Patients with low back pain manifest different clinical symptoms according to underlying pathophysiologies]. These distinctions can be useful for predicting outcomes and for selecting patients for appropriate treatment.

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What causes low back pain?

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Babies may have a variety of causes of sudden low back pain, ranging from back pain caused by simple sprained ankle to back pain caused by a ruptured disc. In this manner, the most effective approach to diagnosis and treatment may be to reassure parents and providers that back pain may often be a normal part of childhood, rather than a medical emergency.

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Have there been any new discoveries for treating low back pain?

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A randomized clinical trial may help determine new treatments to treat low back pain. Since low back pain has so many possible causes, many different treatments have been tried, however, evidence for their efficacy has not been strong. New treatments, such as medications, are under investigation. The most successful method to treat low back pain has been nonsurgical treatments, such as a hot bottle, heat packs, and other modalities. Some patients benefit from nonsurgical treatments, though, people often need surgical treatment to relieve back pain [references 1-3].

Unverified Answer

Have there been other clinical trials involving digital program?

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One major difference is that digital program, while effective, is less effective with moderate levels of pain, and it may not help resolve the patient's pain effectively enough. In addition, it is unclear whether digital program help patients recover from a period of disability due to low back pain by providing positive outcomes.

Unverified Answer

Has digital program proven to be more effective than a placebo?

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Results from a recent paper the positive effect of the digital program was stronger than for the controls at 6 months and at 6, but not at 12 months.

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Is digital program safe for people?

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The digital program appears to be safe and may have positive effects for those who complete a full assessment. The program is also acceptable to those who choose to receive some assessment. Digital resources might be effective for those with low back pain but the effectiveness needs to be further investigated.

Unverified Answer

What is digital program?

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There was a high prevalence of [back pain](https://www.withpower.com/clinical-trials/back-pain), neck pain and musculoskeletal pain among the patients who participated in the DTP sessions. In the literature, the effect of the DTP on back pain was similar to that of other DTP protocols. However, the DTP was more effective than conventional physical therapy in treating neck pain, but ineffective in treating back and musculoskeletal pain.

Unverified Answer

How does digital program work?

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Recent findings showed low-cost digital program (DGI) improved patients' knowledge and self-efficacy to promote self-management of low back pain. DGI programs should be further developed to be applicable to routine clinical care.

Unverified Answer
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