Feasibility of Using Functional Progression to Guide the Treatment of Adolescent 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: NCT02861456|
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Spondylolysis Spondylolisthesis||Other: Standard Model of Care Other: Alternative Model of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Feasibility of Using Functional Progression to Guide the Treatment of Adolescent Low Back Pain|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
Active Comparator: Standard Care Group
Patient in the treatment arm will receive the Standard Model of Care as prescribed for their condition by their physician including but not limited to Advanced imaging, Rest, Bracing, Physical Therapy, and Medication.
Other: Standard Model of Care
Experimental: Functional Progression Group
Patients who are randomized to the alternative model of care to guide treatment will not have advanced imaging done and will be referred directly to physical therapy care . If the patient is able to functional progress through phase I and II of physical therapy within 3 weeks and phase III within 5 weeks then they return to sport. If patient are unable to progress the are put on rest as a presumed vertebral injury (spondylolysis).
Other: Alternative Model of Care
Other Name: Functional progression program
- Utilization of advanced imaging [ Time Frame: Approximately 3 months (Discharge from medical care (both physician and physical therapist)) ]Advanced imaging will be defined as anything beyond radiography (x-ray) used to diagnose patients low back pain
- Total cost of care [ Time Frame: Approximately 3 months (Discharge from medical care (both physician and physical therapist)) ]Total billed from hospital for the low back pain episode of care
- The number of days to return to all sporting activity. [ Time Frame: Approximately 3 months (Discharge from medical care (both physician and physical therapist)) ]The total number of days from when the patient begins the study to the date when they are released to return to sport by the health care provider
- Change in Numeric Pain Rating Scale [ Time Frame: Baseline, Approximately 3 months (Discharge from medical care (both physician and physical therapist)) ]The Numeric Pain rating scale asks the patient their highest pain in the last 24 hours. The Numeric Pain Rating Scale is a 0-10 scale subjectively assessing a patients perceived level of pain. With 0 on the scale = to no pain, and 10 = to the worst pain imaginable.
- Change in Micheli Functional Scale [ Time Frame: Baseline, Approximately 3 months (Discharge from medical care (both physician and physical therapist)) ]The Micheli Functional Scale is a self-reported measure of functional ability and pain on a 0-100 scale with 0 being no disability and 100 representing maximum disability. This scale has been found to have validity and reliability in young athletes with LBP.
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): NCT02861456
|United States, Ohio|
|Nationwide Children's Hospital Sports and Ortho PT East Broad|
|Columbus, Ohio, United States, 43213|
|Nationwide Children's Hospital Sports and Ortho PT Dublin|
|Dublin, Ohio, United States, 43017|
|Nationwide Children's Hospital Sports and Ortho PT New Albany|
|New Albany, Ohio, United States, 43054|
|Nationwide Children's Hospital Sports and Orthopedic PT Westerville location|
|Westerville, Ohio, United States, 43082|
|Principal Investigator:||Mitchell Selhorst, DPT||Nationwide Children's Hospital|