Clinical trial NCT03532230: Cost Effectiveness of OMT for Chronic Low Back Pain
Official title: Prospective, Multi-center, Cohort Study of the Cost Effectiveness of Osteopathic Manipulative Treatment for Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Rowan University
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2018-05-22
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total Costs
timeFrame: 4 months
Secondary outcomes:
measure: Total Morphine-Equivalents
timeFrame: 4 months
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Stratford
country: United States
facility: Rowan University SOM NeuroMusculoskeletal Institute
state: New Jersey
city: Voorhees
country: United States
facility: The Pain Associates
state: New Jersey
Study officials:
affiliation: Rowan University School of Osteopathic Medicine
name: Richard Jermyn, DO
role: PRINCIPAL_INVESTIGATOR
References: