Cost Effectiveness of OMT for Chronic Low Back Pain

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.

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Key information

Conditions

Lumbar Radiculopathy Bone Diseases Lesion of Sciatic Nerve, Left Lower Limb Lesion of Sciatic Nerve, Right Lower Limb Lumbago With Sciatica, Left Side Lumbago With Sciatica, Right Side Lumbar Spinal Stenosis Lumbar Spondylosis Mononeuropathies Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy Sciatic Neuropathy Spinal Diseases Spinal Stenosis Spondylosis

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Michigan State University, East Lansing, Michigan, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osteopathic manipulative treatment (OMT)

Procedure

No specific OMT techniques will be required for the present study. However, data on the number of OMT sessions patients receive will be collected.

Primary outcomes

Total Costs

Time frame: 4 months

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.

Secondary outcomes

Total Morphine-Equivalents

Time frame: 4 months

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.

Sponsors and collaborators

Lead sponsor

Rowan University

Other

Collaborators

American Osteopathic Association

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: May 22, 2018
Registry last updated: May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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