Cost Effectiveness of OMT for Chronic Low Back Pain

Rowan University

Status: Completed

Conditions: Lumbar Spondylosis; Lesion of Sciatic Nerve, Left Lower Limb; Lumbago With Sciatica, Right Side; Lumbar Spinal Stenosis; Lumbago With Sciatica, Left Side; Lesion of Sciatic Nerve, Right Lower Limb; Lumbar Radiculopathy

Treatments: Procedure: Osteopathic Manipulative Treatment (OMT)

Study type: Observational

Funder types: Other

Identifiers

NCT03532230

AOA-OMT

Details and patient eligibility

About

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.

Enrollment: 146 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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.

Trial design

146 participants in 2 patient groups

Experimental Group

Description:

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.

Treatment:

Procedure: Osteopathic Manipulative Treatment (OMT)

Control Group

Description:

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.