Cost Effectiveness of OMT for Chronic Low Back Pain

NCT ID: NCT03532230

Last Updated: 2020-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-22

Study Completion Date

2020-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Osteopathic Manipulative Treatment (OMT)

Intervention Type 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.

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Osteopathic Association

OTHER

Sponsor Role collaborator

Rowan University

OTHER

Sponsor Role lead

Responsible Party

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Richard Jermyn, DO

Director of the NeuroMusculoskeletal Institute (NMI) and Professor and Chair of Rehabilitation Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Jermyn, DO

Role: PRINCIPAL_INVESTIGATOR

Rowan University School of Osteopathic Medicine

Locations

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Michigan State University

East Lansing, Michigan, United States

Site Status

Rowan University SOM NeuroMusculoskeletal Institute

Stratford, New Jersey, United States

Site Status

The Pain Associates

Voorhees Township, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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AOA-OMT

Identifier Type: -

Identifier Source: org_study_id

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