Rest Before Physical Therapy in Adolescents With Active Spondylolysis and Spondylolisthesis

NCT02332200 | Completed

• 1 other identifier: IRB14-00848
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 4

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.

Conditions

Spondylolysis; Spondylolisthesis; Low Back Pain

Keywords

Spondylolysis; Spondylolisthesis; Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Rest before cleared for return to sport

  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)

  Time to event (up to 52 weeks)

• Significant recurrence of symptoms

  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 .

  At follow-up questionnaire (1-5 years after treatment)

Secondary Outcomes (4)

• Numeric Pain Rating Scale (NRPS)

  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)

• Number of Physician Visits

  Time to discharge from physicians care (up to 104 weeks)

• Number of Physical Therapy Visits

  Time to discharge from physical therapy care (up to 104 weeks)

• Compliance with prescribed care

  Time to discharge from physicians care (up to 104 weeks)

Study Arms (2)

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

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

Interventions

Physical Therapy OTHER

Physical therapy will consist of standard physical therapy care for spondylolysis or spondylolisthesis.

Early referral to therapy; Later referral to therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (4)

Nationwide Children's Hospital Sports and Ortho PT Ortho Center

Columbus, Ohio, 43205, United States

Location

Nationwide Children's Hospital Sports and Ortho PT East Broad

Columbus, Ohio, 43213, United States

Location

Nationwide Children's Hospital Sports and Ortho PT Dublin

Dublin, Ohio, 43017, United States

Location

Nationwide Children's Hospital Sports and Ortho PT Westerville

Westerville, Ohio, 43082, United States

Location

Related Publications (2)

• Selhorst M, Fernandez-Fernandez A, Schmitt L, Hoehn J. Effect of a Psychologically Informed Intervention to Treat Adolescents With Patellofemoral Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Jul;102(7):1267-1273. doi: 10.1016/j.apmr.2021.03.016. Epub 2021 Apr 7.

  PMID: 33838141 DERIVED

• Selhorst M, Fischer A, Graft K, Ravindran R, Peters E, Rodenberg R, MacDonald J. Long-Term Clinical Outcomes and Factors That Predict Poor Prognosis in Athletes After a Diagnosis of Acute Spondylolysis: A Retrospective Review With Telephone Follow-up. J Orthop Sports Phys Ther. 2016 Dec;46(12):1029-1036. doi: 10.2519/jospt.2016.7028. Epub 2016 Nov 8.

  PMID: 27825292 DERIVED

MeSH Terms

Conditions

Spondylolysis; Spondylolisthesis; Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Mitchell Selhorst, DPT

  Nationwide Childrens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist/Research Coordinator

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 6, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Locations

US (4)