Cost Effectiveness of OMT for Chronic Low Back Pain

Completed

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT03532230

Run by

Rowan University

People needed

146

Starts

2019-03-22

Expected to finish

2020-02-28

Last updated by the study team

2020-05-04

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Michigan State University — East Lansing, Michigan, United States
• Rowan University SOM NeuroMusculoskeletal Institute — Stratford, New Jersey, United States
• The Pain Associates — Voorhees Township, New Jersey, United States

Full record on ClinicalTrials.gov

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