Cost Effectiveness of OMT for Chronic Low Back Pain

Study Overview
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Brief Summary
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The specific aim of this study is to conduct a prospective, multicenter cohort study over four months to compare the cost of standard of allopathic care (control group, N=90) versus standard of care plus osteopathic manipulative treatment (experimental group, N=90) in a cohort of 180 consecutive patients seeking treatment for chronic low back pain at three osteopathic clinics and three allopathic medical clinics (offering only standard care) located in three different regions of the United States.

Official Title
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Prospective, Multi-center, Cohort Study of the Cost Effectiveness of Osteopathic Manipulative Treatment for Chronic Low Back Pain

Conditions
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Lumbar Radiculopathy, Lesion of Sciatic Nerve, Left Lower Limb, Lesion of Sciatic Nerve, Right Lower Limb, Lumbar Spinal Stenosis, Lumbar Spondylosis, Lumbago With Sciatica, Left Side, Lumbago With Sciatica, Right Side

Intervention / Treatment
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* Procedure: Osteopathic Manipulative Treatment (OMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with chronic low back pain (lasting more than 3 months) who are between 18 to 84 years old will be eligible for the study. Inclusion criteria will be specified by the following the 2017/2018 International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes associated with chronic low back pain: M54.16 Lumbar radiculopathy G57.01 Lesion of sciatic nerve, right lower limb G57.02 Lesion of sciatic nerve, left lower limb M48.061 Lumbar spinal stenosis, without neurogenic claudication M48.062 Lumbar spinal stenosis, with neurogenic claudication M47.816 Lumbar spondylosis M48.07 Lumbar spinal stenosis, lumbosacral M54.41 Lumbago with sciatica, right side M54.42 Lumbago with sciatica, left side Exclusion Criteria: Patients with diabetic neuropathy, congenital lumbar and sacral abnormalities, lumbar fracture, multiple myeloma, metastatic bone disease, history of spinal and/or pain lasting less than three months will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental Group<br>90 new patients seeking treatment for chronic low back pain. This group will receive standard care plus osteopathic manipulative treatment (OMT) for low back pain. | Procedure: Osteopathic Manipulative Treatment (OMT)<br>* No specific OMT techniques will be required for the present study. However, data on the number of OMT sessions patients receive will be collected.<br>|
| Control Group<br>90 new patients seeking treatment for chronic low back pain. This group will receive only standard care without osteopathic manipulative treatment (OMT) for low back pain. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Costs | The cost data will be collected from the electronic medical record of each patient enrolled in the study. Because the costs for comparable treatments vary with respect to different socioeconomic and geographic regions in the United States, the mean total-healthcare costs per patient will be calculated based on codes for 2018 Medicare fee schedules for each clinic listed in the Current Procedural Terminology (CPT) for office visits, medications, OMT, and referrals. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Morphine-Equivalents | Various pain medications that might have been prescribed will be calculated and compared to morphine equivalents at admission to the study and after four months at each of the treatment centers. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Low Back Pain, Osteopathic Manipulative Medicine