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Trial record 3 of 147 for:    "Spondylolysis"

Rest Before Physical Therapy in Adolescents With Active Spondylolysis and Spondylolisthesis

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ClinicalTrials.gov Identifier: NCT02332200
Recruitment Status : Recruiting
First Posted : January 6, 2015
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Mitchell Selhorst, Nationwide Children's Hospital

Brief Summary:

This is a retrospective chart review with a short follow-up phone questionnaire for our patients who have been treated by Nationwide Children's Hospital physical therapy and sports medicine for a spondylolysis or spondylolisthesis injury.

Currently, no research exists to guide referral for safe physical therapy rehabilitation for patients with spondylolysis and spondylolisthesis injuries. By performing this retrospective study the investigators can gain information to better guide physical therapy referral time. This may also serve as foundation for a future prospective randomized trial.

Currently, Nationwide Children Hospital physicians vary from immediate referral to physical therapy to 3 + months of rest prior to beginning therapy. By performing a retrospective chart review assessing time to referral to therapy and patient outcomes the investigator can gain some guidance for when it is safe to prescribe physical therapy rehabilitation for patients with spondylolysis and spondylolisthesis injuries.

Patients with an active spondylolysis or spondylolisthesis injury who are referred to physical therapy early will return to activity/sport sooner without increased risk of adverse reaction.


Condition or disease Intervention/treatment
Spondylolysis Spondylolisthesis Low Back Pain Other: Physical Therapy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Rest Before Physical Therapy in Adolescents With Active Spondylolysis and Spondylolisthesis.
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
Early referral to therapy
Patients with a confirmed diagnosis of spondylolysis or spondylolisthesis whose physicians median referral to physical therapy time is less than or equal to 10 weeks.
Other: Physical Therapy
Physical therapy will consist of standard physical therapy care for spondylolysis or spondylolisthesis.

Later referral to therapy
Patients with a confirmed diagnosis of spondylolysis or spondylolisthesis whose physicians median referral to physical therapy time is >10 weeks.
Other: Physical Therapy
Physical therapy will consist of standard physical therapy care for spondylolysis or spondylolisthesis.




Primary Outcome Measures :
  1. Rest before cleared for return to sport [ Time Frame: Time to event (up to 52 weeks) ]
    Number of days the patient is at rest per doctor's orders prior to time to return sport. Return to sport is decided by physician's Activity Recommendation for full return to participation. If the physician requests modified participation in their last note, return to sport will be decided by Physical therapist notes. If no mention of full return to sport is made by the physical therapist then the last day of physical therapy will be considered the day the patient made a full return to sport. (This is when the PT decided no more limitations exist)

  2. Significant recurrence of symptoms [ Time Frame: At follow-up questionnaire (1-5 years after treatment) ]
    An unplanned visit to physician due to a worsening of symptom during the treatment of spondylolysis or spondylolisthesis. As well as responding yes to having a significant recurrence reported on follow up questionnaire .


Secondary Outcome Measures :
  1. Numeric Pain Rating Scale (NRPS) [ Time Frame: Baseline, visit physician prescribes therapy (average 10 weeks after baseline), discharge (average 4-6 month after baseline), and on follow-up questionnaire (1-5 years post treatment) ]
    Average of the recorded values for NRPS: pain at rest, pain with ADL's, and pain with activity. If the patient is not allowed to participate in activity, pain will be an average of pain at rest and with ADL's.

  2. Number of Physician Visits [ Time Frame: Time to discharge from physicians care (up to 104 weeks) ]
    The number of attended physicians visits for the initial episode of care for treatment of the low back injury only.

  3. Number of Physical Therapy Visits [ Time Frame: Time to discharge from physical therapy care (up to 104 weeks) ]
    The number of attended physical therapy visits for the initial episode of care for treatment of the low back injury only. Physical therapy visits for low back pain prior to rest from sport will be excluded from visit count.

  4. Compliance with prescribed care [ Time Frame: Time to discharge from physicians care (up to 104 weeks) ]
    Reported compliance with physician instructions for care as reported in physician note, if physician makes no comment and the patient attends at least 80% of prescribed physical therapy and physician appointments in the prescribed time frame patient will be considered compliant. (ie 12 physical therapy visits ordered over 6 weeks. Patient must attend 10 visits in 6 weeks)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a confirmed diagnosis of spondylolysis and spondylolisthesis who have been treated by Nationwide Children's Hospital Sports Medicine physicians and physical therapists from 12/2009-12/2013.
Criteria

Inclusion Criteria:

  • Patient must have been treated by the Nationwide Children's sports medicine physicians as well as Nationwide Children's sports and orthopedic physical therapists for spondylolysis or spondylolisthesis from 2009-2013 confirmed by MRI or Bone Scan.

Exclusion Criteria:

  • Diagnosis made by: X-ray, CT, suspicion

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): NCT02332200


Contacts
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Contact: Mitchell Selhorst, DPT 614-355-9764 Mitchell.Selhorst@Nationwidechildrens.org

Locations
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United States, Ohio
Nationwide Children's Hospital Sports and Ortho PT Ortho Center Recruiting
Columbus, Ohio, United States, 43205
Principal Investigator: Mitchell C Selhorst, DPT         
Nationwide Children's Hospital Sports and Ortho PT East Broad Recruiting
Columbus, Ohio, United States, 43213
Contact: Mitchell Selhorst, DPT    614-355-9764    Mitchell.Selhorst@Nationwidechildrens.org   
Principal Investigator: Mitchell C Selhorst, DPT         
Nationwide Children's Hospital Sports and Ortho PT Dublin Not yet recruiting
Dublin, Ohio, United States, 43017
Sub-Investigator: Kristine Graft, DPT         
Nationwide Children's Hospital Sports and Ortho PT Westerville Not yet recruiting
Westerville, Ohio, United States, 43082
Sub-Investigator: Joshua Kempton, DPT         
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Mitchell Selhorst, DPT Nationwide Childrens Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mitchell Selhorst, Physical Therapist/Research Coordinator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02332200     History of Changes
Other Study ID Numbers: IRB14-00848
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Keywords provided by Mitchell Selhorst, Nationwide Children's Hospital:
Spondylolysis
Spondylolisthesis
Low Back Pain

Additional relevant MeSH terms:
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Spondylolysis
Back Pain
Low Back Pain
Spondylolisthesis
Pain
Neurologic Manifestations
Signs and Symptoms
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases