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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03532230
Other study ID # AOA-OMT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 22, 2019
Est. completion date February 28, 2020

Study information

Verified date May 2020
Source Rowan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date February 28, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 84 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Michigan State University East Lansing Michigan
United States Rowan University SOM NeuroMusculoskeletal Institute Stratford New Jersey
United States The Pain Associates Voorhees New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Rowan University American Osteopathic Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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