Cost Effectiveness of OMT for Chronic Low Back Pain

May 1, 2020 updated by: Richard Jermyn, DO, Rowan University

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rowan University

Collaborators

American Osteopathic Association

Investigators

  • Principal Investigator: Richard Jermyn, DO, Rowan University School of Osteopathic Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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