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
NCT number | NCT03532230 |
Other study ID # | AOA-OMT |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 22, 2019 |
Est. completion date | February 28, 2020 |
Verified date | May 2020 |
Source | Rowan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Rowan University | American Osteopathic Association |
United States,
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 |
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