An Immediate Functional Progression Program for Adolescent Athletes With Spondylolysis

NCT05505981 | Completed

• 1 other identifier: STUDY00002285
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

Spondylolysis, a stress fracture in the pars interarticularis of a lumbar vertebra, is the most common identifiable cause of low back pain (LBP) in adolescent athletes, occurring in 14-30% of athletes who experience LBP. Spondylolysis can cause significant pain and disability and months of exclusion from sports or an active lifestyle. Standard care of spondylolysis in adolescent athletes is primarily based on expert opinion, with dramatic variations in clinical practice, including restrictive bracing, extended rest periods before the intervention, long durations out of sport and activity, and suboptimal long-term clinical outcomes. As the next step towards our research goal, the overall objective of this pilot study is to perform a pilot randomized controlled trial to assess a novel rehabilitation strategy, the immediate functional progression program (IFPP), for treating active spondylolysis in adolescent athletes. Participants randomized to the IFPP group will begin physical therapy immediately (\<1 week) after diagnosis. In contrast, those in the standard care group (control) will not start physical therapy until their pain has resolved. Aim 1 will evaluate the effects of the IFPP on outcomes (Function, Pain, Quality of Life, and Edema on MRI) among adolescent athletes with an active spondylolysis. Aim 2 will assess the feasibility of performing a full randomized trial using the novel IFPP to treat athletes ages 10-19 with an active spondylolysis. Aim 3 will compare the tolerability of the IFPP to standard care. This pilot study will lay the necessary groundwork to perform a larger hypothesis-driven randomized controlled trial.

Conditions

Lumbar Spondylosis

Keywords

Adolescent; Athlete; low back pain

Outcome Measures

Primary Outcomes (4)

• Change in Micheli Functional Scale (MFS)

  The Micheli Functional Scale is a measure of function and pain designed for adolescent athletes with low back pain. The MFS is score on 0-100% scale with 0% representing no disability and 100% representing maximum disability.

  Baseline, 1 month, 3 months, 6 months, 1 year

• Change in edema on MRI

  Patients will have a repeat MRI performed at 3 months. A radiologist will assess for change in the spondylolytic lesion, edema and anterolisthesis.

  Baseline, 3 months

• Change in Quality of Life

  Pediatric Quality of Life Inventory (PedsQL). The PedsQL is a 23-item health status instrument that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18. Each item uses a 5-point Likert scale from 0 (Never) to 4 (Almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better Health Related Quality of Life.

  Baseline, 1 month, 3 months, 6 months, 1 year

• Time to return to sport (days)

  The number of days from diagnosis of spondylolysis to the point the patient passes all criteria of the PT program and is cleared to return to sport.

  1-6 months

Secondary Outcomes (3)

• Change in Cross Sectional Area of Lumbar Multifidus

  Baseline, 3 months

• Change in Depressive Symptoms

  Baseline, 1 month, 3 months, 6 months, 1 year

• Change in Fear Avoidance Beliefs

  Baseline, 1 month, 3 months, 6 months, 1 year

Study Arms (2)

Immediate Functional Progression Group

EXPERIMENTAL

Athletes randomized to this group will start Physical Therapy immediately (with 7 days of diagnosis). Once in PT, Athletes will perform phase I (neutral spine) of the program and progress to phase II (functional motion) as able without an increase in pain and without compensations noted in function. The athlete will be assessed at each session to determine if they meet the criteria to begin the next step of functional progression program. Once the athlete has met the criteria of phase II, they will progress into the final phase of the functional progression program for return to sport activity. As these athletes progress through the third phase, and are able to meet the return to sport criteria, they will be released to return to sport. Athletes will not be released to return to sport prior to their first physician follow-up visit at 4 weeks.

Other: Immediate PT

Rest until pain resolves Group

ACTIVE COMPARATOR

Athletes with an active spondylolysis randomized into the control group will rest from all activity until their pain has resolved. Physicians will assess pain resolution at each visit which occurs every four weeks. Once the pain has resolved, the patient will be referred to physical therapy (PT) two times per week. The time, frequency, and exercise progression will be the same as the IFPP group. Since the pain has resolved in these participants be-fore initiating PT, the criteria to progress through phases will be time-based, not pain and function-based.

Other: Rest until pain resolves

Interventions

Immediate PT OTHER

Patients will start PT immediately

Immediate Functional Progression Group

Rest until pain resolves OTHER

Patients will wait to start PT until their pain resolves

Rest until pain resolves Group

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 10 and 19 years.
• Active spondylolysis diagnosed by a participating physician using MRI. Signs of active spondylolysis are defined as edema in the posterior elements of the lumbar vertebrae at the pars interarticularis with or without a fracture.
• Organized sport participation at least two times per week at the time of diagnosis or onset of LBP.

You may not qualify if:

• Previous rest from activity \> four weeks due to LBP
• Numbness or tingling in any lumbar dermatome.
• Other injury or condition that would alter the plan of care for spondylolysis (i.e., pregnancy, anterior cruci-ate ligament tear in the knee, concussion).
• History of lumbar spine surgery.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Children's Hospital Colorado: collaborator

Study Sites (2)

Children's Hospital of Colorado

Denver, Colorado, 80045, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

Location

Related Publications (7)

• 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

• 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

• Selhorst M, Allen M, McHugh R, MacDonald J. REHABILITATION CONSIDERATIONS FOR SPONDYLOLYSIS IN THE YOUTH ATHLETE. Int J Sports Phys Ther. 2020 Apr;15(2):287-300.

  PMID: 32269862 BACKGROUND

• 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 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

• Selhorst M, MacDonald J, Martin LC, Rodenberg R, Krishnamurthy R, Ravindran R, Fischer A. Immediate functional progression program in adolescent athletes with a spondylolysis. Phys Ther Sport. 2021 Nov;52:140-146. doi: 10.1016/j.ptsp.2021.08.009. Epub 2021 Aug 23.

  PMID: 34487947 RESULT

• Selhorst M, Sweeney E, Martin LC, Yang J, Benedict J, Brna M; Spondylolysis Physician Group; Fischer AN. Immediate physical therapy is beneficial for adolescent athletes with active lumbar spondylolysis: a multicentre randomised trial. Br J Sports Med. 2026 Jan 19;60(2):125-132. doi: 10.1136/bjsports-2025-110606.

  PMID: 41402030 DERIVED

MeSH Terms

Conditions

Spondylosis; Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 18, 2022
• Study Start: August 22, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (2)