Cost Effectiveness of OMT for Chronic Low Back Pain

Lumbar Spinal Stenosis Clinical Trial

Official title:

Prospective, Multi-center, Cohort Study of the Cost Effectiveness of Osteopathic Manipulative Treatment for Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532230
• Other study ID #: AOA-OMT
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Back Pain
• Lesion of Sciatic Nerve, Left Lower Limb
• Lesion of Sciatic Nerve, Right Lower Limb
• Low Back Pain
• Lumbago With Sciatica, Left Side
• Lumbago With Sciatica, Right Side
• Lumbar Radiculopathy
• Lumbar Spinal Stenosis
• Lumbar Spondylosis
• Radiculopathy
• Sciatic Neuropathy
• Sciatica
• Spinal Stenosis
• Spondylosis

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