Treatment for Low Back Pain

Phase-Based Estimates
1
Effectiveness
1
Safety
Northwell Health, Great Neck, NY
Low Back Pain+1 More
Eligibility
18+
All Sexes
Eligible conditions
Low Back Pain

Study Summary

This study is evaluating whether a new treatment for chronic pain called ReActiv8 Therapy is better than standard medical care.

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Eligible Conditions

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

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 2 secondary outcomes in patients with Low Back Pain. Measurement will happen over the course of 1 year.

1 year
Change in EQ-5D
Change in Low Back Pain Numerical Rating Scale (LBP NRS)
Change in Oswestry Disability Index (ODI)

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Groups

Control

This trial requires 230 total participants across 1 different treatment groups

This trial involves a single treatment. Treatment 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.

ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Northwell Health - Great Neck, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Failed therapy including pain medications and physical therapy
Age ≥21 years
Evidence of lumbar multifidus muscle dysfunction
Intractable Chronic Low Back Pain that has persisted >6 months resulting in pain most of the days in the past 12 months
Not a candidate for spine surgery
Low Back Pain NRS of ≥6 and ≤9
Oswestry Disability Index score ≥30 and ≤60
Willing and capable of giving Informed Consent
Able to comply with this protocol

Patient Q&A Section

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

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

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around 26 million Americans experience low [back pain](https://www.withpower.com/clinical-trials/back-pain) each year. Those who do so tend to have recurrent episodes of pain. About 20% of the American population suffers from back pain a year and over two million every year seek treatment. More than half a million Americans are hospitalized each year with low back disease.

Unverified Answer

What are common treatments for low back pain?

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LBP is common and is frequently treated. There are a variety of treatments for LBP currently, but the majority use conventional treatments and/or physical therapies. The efficacy of conservative treatment is not proven and there are numerous risks involved in conventional treatments. For physical therapies, high quality trials with evidence-based guidelines are lacking.

Unverified Answer

What are the signs of low back pain?

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Specific signs that are suggestive of low back pain should be considered when seeking medical help in patients with chronic low back pain. The clinical examination should be the leading tool for diagnosing the cause of lumbago and is also a valid measure to identify those patients who should be offered alternative diagnostic tests.

Unverified Answer

Can low back pain be cured?

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Unfortunately, most current treatments appear to be only moderately efficacious (e.g. medication, psychotherapy and exercise) for pain relief in low back pain. Further research should be directed to identify a novel, multi-dimensional "treatment" for chronic low back pain that effectively reduces pain and improves function.

Unverified Answer

What is low back pain?

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Most LBP cases are chronic in nature and cause high levels of pain and disability in affected patients. The duration, intensity, and frequency of the LBP episodes have shown to be an important predictor of the severity of chronic LBP in patients. It is worth emphasizing that the management of LBP is not just focused on relieving pain but also addressing the physical and family issues. So far, we have no way to predict which patients are going to experience LBP pain long term so, the future research should focus on finding the best way to predict the long term progression of LBP.

Unverified Answer

What causes low back pain?

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A diagnosis of [back pain](https://www.withpower.com/clinical-trials/back-pain) can be difficult due to the wide range of causes. There is no single definitive cause of lumbago which is the most common cause of low back pain. Therefore, it is vital that a clear explanation of the cause of the pain is ascertained before the diagnosis of lumbago is made or an accurate prognosis is made.

Unverified Answer

Is treatment typically used in combination with any other treatments?

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The most commonly used treatments are nonsteroidal anti-inflammatory drugs, manual therapy, and narcotic analgesics. All are commonly used in combination with other treatments and are effective in improving quality of life in LBP patients. The combination of treatment is the most effective way to decrease pain and to improve quality of life; it involves nonsteroidal anti-inflammatory drugs, manual therapy, and narcotic analgesics.

Unverified Answer

What does treatment usually treat?

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In a recent study, findings of this sample of older women suggest that therapists, educators, and other caregivers may wish to address the possibility that some people with chronic pain have a nociceptive component to their symptom experience. Treating this component in patients may be a nalog tool that contributes to patient engagement and outcomes.

Unverified Answer

What are the common side effects of treatment?

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Results from a recent clinical trial suggests that side effects of treatment in lumbar degenerative disease may vary for different spine surgeons and from one patient to the next. It also supports the inclusion of all possible side effects in the medical record in order to prevent bias in treatment choice and assist with post-treatment patient decision-making. It further indicates that there is a need for a more standardized method to classify and report side effects.

Unverified Answer

Who should consider clinical trials for low back pain?

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Most of the physicians who are interested in participating in a clinical trial for LBP do not consider any major barriers to participation. Thus, the time and inconvenience incurred would be low and would not be a major barrier to study participation. The cost of participation would not affect participation decision. Furthermore, most of the physicians would want a higher threshold for prescribing NSAIDs, suggesting that participation in such trials might not be a big barrier to study drug prescribing.

Unverified Answer

Is treatment safe for people?

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[Treatment of lumbar spine pain following cervical disk herniation is generally safe and well-tolerated.] This is particularly true for women and younger patients. The evidence supports caution regarding the safety of using epidural corticosteroids or epidural local anesthetics for treatment of long-term lumbar spine pain or disability following cervical disk herniation.

Unverified Answer

What is the latest research for low back pain?

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The last 10 years has brought important improvements in the treatments for LBP and pain. However, the current understanding of how LBP and pain work to cause damage to the body seems to be limited. Clinical trials for LBP and pain treatments that focus on the brain are likely to have the best results. [Determining Treatment Effects of Back Pain (http://www.thedie.org/news/2011/07/determining-treatment-effects-of-back-pain) The NIH Clinical Centers has established seven Clinical Centers (Limbic LBP Initiative), and they are [going to study low back pain more systematically.

Unverified Answer
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