Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cost Effectiveness of OMT for Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03532230
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : May 4, 2020
Sponsor:
Collaborator:
American Osteopathic Association
Information provided by (Responsible Party):
Richard Jermyn, DO, Rowan University

Brief Summary:
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.

Condition or disease Intervention/treatment
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 Procedure: Osteopathic Manipulative Treatment (OMT)

Layout table for study information
Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multi-center, Cohort Study of the Cost Effectiveness of Osteopathic Manipulative Treatment for Chronic Low Back Pain
Actual Study Start Date : March 22, 2019
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532230


Locations
Layout table for location information
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
United States, New Jersey
Rowan University SOM NeuroMusculoskeletal Institute
Stratford, New Jersey, United States, 08084
The Pain Associates
Voorhees, New Jersey, United States, 08043
Sponsors and Collaborators
Rowan University
American Osteopathic Association
Investigators
Layout table for investigator information
Principal Investigator: Richard Jermyn, DO Rowan University School of Osteopathic Medicine
Layout table for additonal information
Responsible Party: Richard Jermyn, DO, Director of the NeuroMusculoskeletal Institute (NMI) and Professor and Chair of Rehabilitation Medicine, Rowan University
ClinicalTrials.gov Identifier: NCT03532230    
Other Study ID Numbers: AOA-OMT
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Jermyn, DO, Rowan University:
Chronic Low Back Pain
Osteopathic Manipulative Medicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Stenosis
Spondylosis
Radiculopathy
Sciatica
Sciatic Neuropathy
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Mononeuropathies
Neuralgia