CLINICAL TRIAL

ED Physical Therapy for Low Back Pain

Recruiting · 18+ · All Sexes · Chicago, IL

This study is evaluating whether an emergency department physical therapy model can improve patient functioning and reduce opioid use.

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About the trial for Low Back Pain

Eligible Conditions
Back Pain · Low Back Pain

Treatment Groups

This trial involves 2 different treatments. ED Physical Therapy 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
ED Physical Therapy
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Most patients who are likely to be discharged home will be based on the physician's assessment. show original
The study will be able to complete follow-up data collection electronically or by telephone. show original
English-speaking
Age ≥ 18 years
Low back pain (originating between 12th rib and buttocks)
If you are experiencing symptoms that last for 30 days or less, it is considered a current episode. show original
Evaluated by a physician randomized to either study arm
The text is saying that the evaluation will take place during the hours that the physical therapy clinic is open. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Three months after the index ED visit.
Screening: ~3 weeks
Treatment: Varies
Reporting: Three months after the index ED visit.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Three months after the index ED visit..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether ED Physical Therapy will improve 1 primary outcome, 2 secondary outcomes, and 9 other outcomes in patients with Low Back Pain. Measurement will happen over the course of Index ED 1 day visit..

ED Diagnostic Imaging Utilization
INDEX ED 1 DAY VISIT.
We will assess the proportion of ED visits in which any diagnostic imaging of the lower back was performed, including plain radiography, computed tomography, or magnetic resonance imaging.
INDEX ED 1 DAY VISIT.
Advanced Healthcare Resource Utilization
THREE MONTHS AFTER THE INDEX ED VISIT.
We will assess the proportion of participants who utilized any advanced healthcare resources for low back pain after their index ED visit, defined as advanced imaging (e.g., magnetic resonance imaging) or procedures/surgery (e.g., epidural steroid injection, lumbar discectomy).
THREE MONTHS AFTER THE INDEX ED VISIT.
Pain Catastrophizing Scale (PCS-4)
THREE MONTHS AFTER THE INDEX ED VISIT.
The original PCS is a 13-item survey measuring the degree to which an individual catastrophizes in response to pain. PCS scores correlate closely with pain intensity and disability over time; higher PCS scores are associated with progression from acute to chronic pain. We will utilize the brief 4-item PCS measure containing original items 3, 6, 8, and 11.
THREE MONTHS AFTER THE INDEX ED VISIT.
Patient-Reported Prescription Analgesic Use in Last 24 Hours
THREE MONTHS AFTER THE INDEX ED VISIT.
Patient-reported prescription analgesic use will be collected using the same customized instrument described above for opioid use. Prescription analgesics include the following: opioids, benzodiazepines, skeletal muscle relaxants, and gabapentinoids.
THREE MONTHS AFTER THE INDEX ED VISIT.
Opioid Prescription Filling
THREE MONTHS AFTER THE INDEX ED VISIT.
Opioid prescription filling data will be queried in the state prescription monitoring database.
THREE MONTHS AFTER THE INDEX ED VISIT.
Patient-Reported Opioid Use in Last 24 Hours
THREE MONTHS AFTER THE INDEX ED VISIT.
Patient-reported opioid use will be collected using a customized instrument assessing whether participants have taken any opioid medication in the last 24 hours (binary yes/no). The 24-hour timeframe was selected to maximize accuracy in patient recall and has been used previously. In brief, opioid medications are listed by brand and generic names; a "yes" response to any medication triggers an additional query asking the participant to specify the medication dose (e.g., oxycodone 10mg) and quantity (e.g., four pills), allowing for standardization by morphine milligram equivalents.
THREE MONTHS AFTER THE INDEX ED VISIT.
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Who is running the study

Principal Investigator
H. K.
Prof. Howard Kim, Assistant Professor
Northwestern University

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?

Results from a recent paper suggested that low back pain is related to the combination of depressive disorders, anxiety disorder, emotional disturbance, and somatization symptoms.

Anonymous Patient Answer

Has ed physical therapy proven to be more effective than a placebo?

ED physical therapy should be considered for those with chronic LBP and those older than 55 years given that it showed moderate effect size for the short-term effect of treatment. A further review of the data regarding the effect of other modalities, such as medications, for those with chronic LBP is desirable.

Anonymous Patient Answer

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

Low back pain is the most common musculoskeletal illness, more common than arthritis and other musculoskeletal disorders. The lifetime prevalence of low back pain is high with over 33% of the population affected.

Anonymous Patient Answer

Can low back pain be cured?

Recent findings of this study confirm that treatment based on the patient's needs is most effective. However, in some instances, treatment based on symptom reports to the physicians and therapists is a viable alternative.

Anonymous Patient Answer

What are common treatments for low back pain?

A majority of patients with low back pain can be managed conservatively during an initial episode for up to 6 weeks. The optimal course of management for chronic low back pain is still not clear. However, most patients can be managed appropriately and may not need long-term opioid or nonsteroidal anti-inflammatory drug (NSAID) treatment.

Anonymous Patient Answer

What causes low back pain?

Low [back pain](https://www.withpower.com/clinical-trials/back-pain) is due to physical factors such as tightness of muscles and ligaments. Painful behavior is related to anxiety and depression, both psychological factors, as well as physical factors such as spinal disc herniation and degenerative disc disease.

Anonymous Patient Answer

What are the signs of low back pain?

The majority of [back pain](https://www.withpower.com/clinical-trials/back-pain) cases may not be symptomatic at the time of presentation. A history of low back trauma is considered a risk factor for back pain. In addition to this, there are many subtle signs of back pain. The key clinico-radiological features of back pain such as low back pain, leg pain and the disc(c)herange are not readily identifiable on radiographs. The term 'back pain' may be misleading in clinical practice. For this reason, back pain should be referred to as 'low back pain', 'lumbar pain' or 'lower back pain' in clinical practice.

Anonymous Patient Answer

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

The evidence from the existing research for therapies for low back pain is limited. The use of spinal manipulative techniques in chronic low back pain may be effective. Randomized controlled trials are urgently needed to test some of the therapeutic approaches. Findings from a recent study of such studies will probably be available at the end of 2001, if the current trial in New Zealand with high risk patients for low back pain is successful.

Anonymous Patient Answer

Who should consider clinical trials for low back pain?

It appears reasonable to offer a trial for patients with low [back pain](https://www.withpower.com/clinical-trials/back-pain) to reduce pain and improve physical function and quality of life. For patients, to be considered for such a trial, the following are optimal entry criteria: a history of low back pain for less than 6 months, age less than 55 yr, and current disability. Clinicians should be concerned with patients with more severe pain or those who are younger, who are female, or who have a history of cancer, and who would be more likely to report adverse events. This article presents a proposal for these entry criteria.

Anonymous Patient Answer

Does low back pain run in families?

The familial risk of lumbar disc herniation in women with LBP was moderate. This is reassuring as a risk for herniated lumbar disc was expected to be greater than that of the normal population.

Anonymous Patient Answer

How does ed physical therapy work?

There was a positive change in pain and patient perceived work ability across all timepoints except at 6-month. Patient-rated functional disability and work ability were positively effected by two weekly group exercises, exercise therapy sessions and home exercise programme. Pain measurement was not a measure of the quality of exercises or treatment. This research suggests therapists should adopt an exercise framework, whilst ensuring the client incorporates active movement, stretching and functional actions as a key element of the programme.

Anonymous Patient Answer

Is ed physical therapy typically used in combination with any other treatments?

Data from a recent study, physical therapy interventions were not used in combination with any other treatments for pain or function. Physical therapy is one of two treatments used to provide multimodal rehabilitation, but it is not used often in multimodality treatment.

Anonymous Patient Answer
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