Cost Effectiveness of OMT for Chronic Low Back Pain

NCT03532230 | Completed

• 1 other identifier: AOA-OMT
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Chronic Low Back Pain; Osteopathic Manipulative Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total Morphine-Equivalents

  4 months

Study Arms (2)

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.

Procedure: Osteopathic Manipulative Treatment (OMT)

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.

Interventions

Osteopathic Manipulative Treatment (OMT) 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This prospective, multicenter, observational study will follow two groups of patients over four months. The first (experimental) group will be 90 new patients seeking treatment for chronic back pain at three osteopathic clinics. The experimental group will receive standard of care plus osteopathic manipulative treatment (OMT) for low back pain. The second (control) group will be 90 new patients who will receive only standard care without OMT for chronic low back pain as delivered at a local pain clinic.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rowan University: lead
• American Osteopathic Association: collaborator

Study Sites (3)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Rowan University SOM NeuroMusculoskeletal Institute

Stratford, New Jersey, 08084, United States

Location

The Pain Associates

Voorhees Township, New Jersey, 08043, United States

Location

MeSH Terms

Conditions

Radiculopathy; Sciatic Neuropathy; Spinal Stenosis; Spondylosis

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Mononeuropathies; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Richard Jermyn, DO

  Rowan University School of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the NeuroMusculoskeletal Institute (NMI) and Professor and Chair of Rehabilitation Medicine

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 22, 2018
• Study Start: March 22, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: May 4, 2020

Record last verified: 2020-05

Locations

US (3)