Cost Effectiveness of OMT for Chronic Low Back Pain

Prospective, Multi-center, Cohort Study of the Cost Effectiveness of Osteopathic Manipulative Treatment 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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis; Lumbar Radiculopathy; Lumbar Spondylosis; Lesion of Sciatic Nerve, Left Lower Limb; Lesion of Sciatic Nerve, Right Lower Limb; Lumbago With Sciatica, Left Side; Lumbago With Sciatica, Right Side
• Intervention / Treatment: Procedure: Osteopathic Manipulative Treatment (OMT)

• Study Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• United States
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan State University
  • New Jersey
    • Stratford, New Jersey, United States, 08084
      • Rowan University SOM NeuroMusculoskeletal Institute
    • Voorhees, New Jersey, United States, 08043
      • The Pain Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This prospective, multicenter, observational study will follow two groups of patients over four months. The first (experimental) group will be 90 new patients seeking treatment for chronic back pain at three osteopathic clinics. The experimental group will receive standard of care plus osteopathic manipulative treatment (OMT) for low back pain.

The second (control) group will be 90 new patients who will receive only standard care without OMT for chronic low back pain as delivered at a local pain clinic.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental Group; 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); No specific OMT techniques will be required for the present study. However, data on the number of OMT sessions patients receive will be collected.
Control Group; 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?

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

Collaborators and Investigators

• Sponsor: Rowan University
• Collaborators: American Osteopathic Association
• Investigators: Principal Investigator: Richard Jermyn, DO, Rowan University School of Osteopathic Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2019
• Primary Completion (ACTUAL): February 28, 2020
• Study Completion (ACTUAL): February 28, 2020

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (ACTUAL): May 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Chronic Low Back Pain; Osteopathic Manipulative Medicine
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Sciatica; Radiculopathy; Spinal Stenosis; Spondylosis; Sciatic Neuropathy
• Other Study ID Numbers: AOA-OMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No