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

NCT02861456 | Completed

• 1 other identifier: IRB16-00032
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

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.

Conditions

Low Back Pain; Spondylolysis; Spondylolisthesis

Keywords

Adolescent; Low Back Pain; Athlete

Outcome Measures

Primary Outcomes (2)

• Utilization of advanced imaging

  Advanced imaging will be defined as anything beyond radiography (x-ray) used to diagnose patients low back pain

  Approximately 3 months (Discharge from medical care (both physician and physical therapist))

• Total cost of care

  Total billed from hospital for the low back pain episode of care

  Approximately 3 months (Discharge from medical care (both physician and physical therapist))

Secondary Outcomes (3)

• The number of days to return to all sporting activity.

  Approximately 3 months (Discharge from medical care (both physician and physical therapist))

• Change in Numeric Pain Rating Scale

  Baseline, Approximately 3 months (Discharge from medical care (both physician and physical therapist))

• Change in Micheli Functional Scale

  Baseline, Approximately 3 months (Discharge from medical care (both physician and physical therapist))

Study Arms (2)

Standard Care Group

ACTIVE COMPARATOR

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

Functional Progression Group

EXPERIMENTAL

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

Interventions

Standard Model of Care OTHER

Standard Care Group

Alternative Model of Care OTHER

Also known as: Functional progression program

Functional Progression Group

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Advanced imaging performed already (MRI, SPECT, CT)
• 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)
• Numbness and tingling in any lumbar dermatome
• Previous rest from sport \>4 weeks without improved symptoms
• Other orthopedic injury or condition that would alter the plan of care for LBP (i.e. pregnancy, concomitant anterior cruciate ligament tear)
• History of lumbar surgery

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (4)

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 New Albany

New Albany, Ohio, 43054, United States

Location

Nationwide Children's Hospital Sports and Orthopedic PT Westerville location

Westerville, Ohio, 43082, United States

Location

Related Publications (13)

• Balague F, Dutoit G, Waldburger M. Low back pain in schoolchildren. An epidemiological study. Scand J Rehabil Med. 1988;20(4):175-9.

  PMID: 2976526 BACKGROUND

• Burton AK, Clarke RD, McClune TD, Tillotson KM. The natural history of low back pain in adolescents. Spine (Phila Pa 1976). 1996 Oct 15;21(20):2323-8. doi: 10.1097/00007632-199610150-00004.

  PMID: 8915066 BACKGROUND

• Ebrall PS. The epidemiology of male adolescent low back pain in a north suburban population of Melbourne, Australia. J Manipulative Physiol Ther. 1994 Sep;17(7):447-53.

  PMID: 7989878 BACKGROUND

• Micheli LJ, Wood R. Back pain in young athletes. Significant differences from adults in causes and patterns. Arch Pediatr Adolesc Med. 1995 Jan;149(1):15-8. doi: 10.1001/archpedi.1995.02170130017004.

  PMID: 7827653 BACKGROUND

• d'Hemecourt PA, Zurakowski D, d'Hemecourt CA, Curtis C, Ugrinow V, Deriu L, Micheli LJ. Validation of a new instrument for evaluating low back pain in the young athlete. Clin J Sport Med. 2012 May;22(3):244-8. doi: 10.1097/JSM.0b013e318249a3ce.

  PMID: 22382433 BACKGROUND

• Miller R, Beck NA, Sampson NR, Zhu X, Flynn JM, Drummond D. Imaging modalities for low back pain in children: a review of spondyloysis and undiagnosed mechanical back pain. J Pediatr Orthop. 2013 Apr-May;33(3):282-8. doi: 10.1097/BPO.0b013e318287fffb.

  PMID: 23482264 BACKGROUND

• El Rassi G, Takemitsu M, Glutting J, Shah SA. Effect of sports modification on clinical outcome in children and adolescent athletes with symptomatic lumbar spondylolysis. Am J Phys Med Rehabil. 2013 Dec;92(12):1070-4. doi: 10.1097/PHM.0b013e318296da7e.

  PMID: 24141103 BACKGROUND

• Iwamoto J, Sato Y, Takeda T, Matsumoto H. Return to sports activity by athletes after treatment of spondylolysis. World J Orthop. 2010 Nov 18;1(1):26-30. doi: 10.5312/wjo.v1.i1.26.

  PMID: 22474624 BACKGROUND

• Selhorst M, Fischer A, Graft K, Ravindran R, Peters E, Rodenberg R, Welder E, MacDonald J. Timing of Physical Therapy Referral in Adolescent Athletes With Acute Spondylolysis: A Retrospective Chart Review. Clin J Sport Med. 2017 May;27(3):296-301. doi: 10.1097/JSM.0000000000000334.

  PMID: 27347866 BACKGROUND

• Klein G, Mehlman CT, McCarty M. Nonoperative treatment of spondylolysis and grade I spondylolisthesis in children and young adults: a meta-analysis of observational studies. J Pediatr Orthop. 2009 Mar;29(2):146-56. doi: 10.1097/BPO.0b013e3181977fc5.

  PMID: 19352240 BACKGROUND

• Congeni J, McCulloch J, Swanson K. Lumbar spondylolysis. A study of natural progression in athletes. Am J Sports Med. 1997 Mar-Apr;25(2):248-53. doi: 10.1177/036354659702500220.

  PMID: 9079183 BACKGROUND

• Iwamoto J, Takeda T, Wakano K. Returning athletes with severe low back pain and spondylolysis to original sporting activities with conservative treatment. Scand J Med Sci Sports. 2004 Dec;14(6):346-51. doi: 10.1111/j.1600-0838.2004.00379.x.

  PMID: 15546329 BACKGROUND

• Childs JD, Fritz JM, Wu SS, Flynn TW, Wainner RS, Robertson EK, Kim FS, George SZ. Implications of early and guideline adherent physical therapy for low back pain on utilization and costs. BMC Health Serv Res. 2015 Apr 9;15:150. doi: 10.1186/s12913-015-0830-3.

  PMID: 25880898 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Spondylolysis; Spondylolisthesis

Condition Hierarchy (Ancestors)

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

Study Officials

• Mitchell Selhorst, DPT

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist/Principle Investigator

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 10, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)