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Feasibility of Using Functional Progression to Guide the Treatment of Adolescent Low Back Pain

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ClinicalTrials.gov Identifier: NCT02861456
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Mitchell Selhorst, Nationwide Children's Hospital

Brief Summary:
The goal of the proposed research is to test the feasibility of a functional progression program to reduce cost and possible radiation exposure for adolescent athletes with low back pain. Specifically the investigators plan to test the feasibility of using progression in rehabilitation to pragmatically differentially diagnose and treat adolescent athletes with low back pain, instead of using advanced imaging which is the current practice. The investigators propose to recruit 20 participants, with 10 of usual care (advanced imaging) and 10 of proposed intervention (functional progression) to assess the feasibility of using functional progress to guide treatment. The outcomes measured will be number of days for rest, time to start regular rehabilitation, pain experienced, functional outcomes, ability to return to sport, time needed to return to sport. If this pilot demonstrates the feasibility and a decreased rate of advanced imaging and similar clinical outcomes the investigators plan to progress this work into larger trials.

Condition or disease Intervention/treatment Phase
Low Back Pain Spondylolysis Spondylolisthesis Other: Standard Model of Care Other: Alternative Model of Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 12-19 years old
  2. Primary complaint of acute low back pain (<3months)
  3. Participates in some type of athletic activity on a regular basis (>2 times a week)
  4. Pain increases with lumbar extension

Exclusion Criteria:

  1. Advanced imaging performed already (MRI, SPECT, CT)
  2. Red flags present (bowel/bladder problems, saddle anesthesia, progressive neurological deficits, recent fever or infection, unexplained weight loss, unable to change symptoms with mechanical testing)
  3. Numbness and tingling in any lumbar dermatome
  4. Previous rest from sport >4 weeks without improved symptoms
  5. Other orthopedic injury or condition that would alter the plan of care for LBP (i.e. pregnancy, concomitant anterior cruciate ligament tear)
  6. History of lumbar surgery

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Mitchell Selhorst, DPT Nationwide Children's Hospital

Publications:

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Responsible Party: Mitchell Selhorst, Physical Therapist/Principle Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02861456     History of Changes
Other Study ID Numbers: IRB16-00032
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mitchell Selhorst, Nationwide Children's Hospital:
Adolescent
Low Back Pain
Athlete
Additional relevant MeSH terms:
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Spondylolysis
Spondylolisthesis
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases