Cost Effectiveness of OMT for Chronic Low Back Pain

Completed

• Conditions: Lesion of Sciatic Nerve, Right Lower Limb; Lumbago With Sciatica, Left Side; Lumbar Radiculopathy; Lesion of Sciatic Nerve, Left Lower Limb; Lumbar Spinal Stenosis; Lumbar Spondylosis; Lumbago With Sciatica, Right Side
• Interventions: Procedure: Osteopathic Manipulative Treatment (OMT)

• Registration Number: NCT03532230
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Study Start: 2019-03-22
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-01
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Group	Osteopathic Manipulative Treatment (OMT)	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.

Primary Outcome Measures

Name	Time	Method
Total Costs	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

Name	Time	Method
Total Morphine-Equivalents	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.

Trial Locations

Locations (3)

Michigan State University; 🇺🇸 East Lansing, Michigan, United States

The Pain Associates; 🇺🇸 Voorhees, New Jersey, United States

Rowan University SOM NeuroMusculoskeletal Institute; 🇺🇸 Stratford, New Jersey, United States