Immediate Physical Therapy for Spondylolysis

Recruiting at 1 trial location

Overseen By Mitchell Selhorst, DPT, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nationwide Children's Hospital

Disqualifiers: Previous rest >4 weeks, Numbness, Other injury, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on physical therapy and does not mention medication changes.

How is the Immediate Functional Progression Program (IFPP) treatment different from other treatments for spondylolysis?

The Immediate Functional Progression Program (IFPP) is unique because it focuses on a structured physical therapy approach that allows for immediate progression in activities, unlike traditional treatments that often rely on bracing and rest. This program aims to restore physical function and relieve pain without the need for restrictive bracing, which can be costly and difficult for patients to comply with. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adolescent athletes aged 10-19 with a recent diagnosis of spondylolysis, which is a type of stress fracture in the lower spine causing back pain. They must be active in sports at least twice weekly and have not taken more than four weeks off due to back pain. Those with previous lumbar surgery, numbness or tingling in the legs, or other serious conditions are excluded.

Inclusion Criteria

I have been diagnosed with active spondylolysis confirmed by MRI.

I am between 10 and 19 years old.

Organized sport participation at least two times per week at the time of diagnosis or onset of LBP

Exclusion Criteria

I feel numbness or tingling in my lower back area.

I do not have any conditions like pregnancy or knee injuries that would change my treatment for a spine condition.

I have had surgery on my lower back.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Functional Progression Program (IFPP)

Participants in the IFPP group begin physical therapy immediately upon diagnosis, progressing through three phases based on function and pain criteria.

Varies until return-to-sport criteria are met

2 visits per week (in-person)

Control Group Treatment

Participants in the control group begin physical therapy after lumbar pain resolves, following a predetermined timeline for progression.

Varies until return-to-sport criteria are met

2 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 month, 3 months, 6 months, and 1 year.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Immediate Functional Progression Program

Trial Overview The study tests an immediate functional progression program (IFPP) against standard care for treating spondylolysis. The IFPP group starts physical therapy within a week after diagnosis while the control group waits until their pain subsides before beginning therapy.

How Is the Trial Designed?

Group I: Immediate Functional Progression Group Experimental Treatment 1 Intervention

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.

Group II: Rest until pain resolves Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Published Research Related to This Trial

A study involving 46 patients with symptomatic spondylolysis and grade I spondylolisthesis showed that a 6-week physical therapy program can effectively relieve pain and restore function without the need for bracing.

Out of the 23 patients who completed the disability assessment, 96% reported minimal disability, with 78% experiencing no pain or functional limitations, indicating that non-bracing conservative management can be a successful treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of Conservative Management in the Treatment of Symptomatic Spondylolysis and Grade I Spondylolisthesis. Boyd, ED., Mundluru, SN., Feldman, DS.[2020]

Isthmic spondylolysis is a common cause of low back pain in adolescent athletes, characterized by pain that worsens with activity, especially during back extension movements.

Despite the frequent recommendation of physical therapy for treating spondylolysis, there is a lack of randomized controlled trials and detailed descriptions of effective rehabilitation strategies for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

REHABILITATION CONSIDERATIONS FOR SPONDYLOLYSIS IN THE YOUTH ATHLETE. Selhorst, M., Allen, M., McHugh, R., et al.[2022]

In a study involving 12 adolescent athletes with active spondylolysis, 92% successfully returned to their sport within an average of 2.5 months, indicating the program's efficacy.

The immediate functional progression program led to significant improvements in pain and function for all participants, with MRI results showing healing in most cases, suggesting it is a promising treatment approach for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate functional progression program in adolescent athletes with a spondylolysis. Selhorst, M., MacDonald, J., Martin, LC., et al.[2022]

Lumbar spondylolysis, a common injury in young athletes due to repetitive hyperextension, can often be effectively managed with conservative treatment, allowing most athletes to return to full participation in sports.

A structured physical therapy program is crucial for recovery from acute pars fractures, although there is limited existing literature on specific PT protocols for spondylolysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spondylolysis in Young Athletes: An Overview Emphasizing Nonoperative Management. Goetzinger, S., Courtney, S., Yee, K., et al.[2020]

In a study of 29 young patients with presumed traumatic spondylolysis treated nonoperatively, only 2 patients healed, indicating that this condition may not be as benign as previously thought.

The treatment regimen included activity modification, full-time bracing, and nonsteroidal anti-inflammatory drugs, suggesting that early and comprehensive management may improve outcomes for patients diagnosed with acute spondylolysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study of the efficacy of nonoperative treatment of presumed traumatic spondylolysis in a young patient population. Daniel, JN., Polly, DW., Van Dam, BE.[2017]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Outcome of Conservative Management in the Treatment of Symptomatic Spondylolysis and Grade I Spondylolisthesis. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

REHABILITATION CONSIDERATIONS FOR SPONDYLOLYSIS IN THE YOUTH ATHLETE. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Immediate functional progression program in adolescent athletes with a spondylolysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Spondylolysis in Young Athletes: An Overview Emphasizing Nonoperative Management. [2020]

5. England pubmed.ncbi.nlm.nih.gov

A study of the efficacy of nonoperative treatment of presumed traumatic spondylolysis in a young patient population. [2017]