Cost Effectiveness of OMT for Chronic Low Back Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03532230|
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : May 4, 2020
|Condition or disease||Intervention/treatment|
|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||Procedure: Osteopathic Manipulative Treatment (OMT)|
|Study Type :||Observational|
|Actual Enrollment :||146 participants|
|Official Title:||Prospective, Multi-center, Cohort Study of the Cost Effectiveness of Osteopathic Manipulative Treatment for Chronic Low Back Pain|
|Actual Study Start Date :||March 22, 2019|
|Actual Primary Completion Date :||February 28, 2020|
|Actual Study Completion Date :||February 28, 2020|
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)
No specific OMT techniques will be required for the present study. However, data on the number of OMT sessions patients receive will be collected.
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.
- Total Costs [ Time Frame: 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.
- Total Morphine-Equivalents [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532230
|United States, Michigan|
|Michigan State University|
|East Lansing, Michigan, United States, 48824|
|United States, New Jersey|
|Rowan University SOM NeuroMusculoskeletal Institute|
|Stratford, New Jersey, United States, 08084|
|The Pain Associates|
|Voorhees, New Jersey, United States, 08043|
|Principal Investigator:||Richard Jermyn, DO||Rowan University School of Osteopathic Medicine|