Immediate Physical Therapy for Spondylolysis

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new physical therapy program for young athletes with spondylolysis, a condition causing back pain due to a small stress fracture in the spine. The goal is to determine if starting physical therapy immediately, rather than waiting for pain to subside, improves pain, function, and quality of life. It compares two groups: one begins therapy immediately, and the other waits until the pain subsides. Athletes between 10 and 19 years old with a recent diagnosis of spondylolysis who play organized sports at least twice a week may be a good fit.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance treatment strategies for young athletes.

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.

What prior data suggests that the Immediate Functional Progression Program is safe for adolescent athletes with spondylolysis?

Research has shown that the Immediate Functional Progression Program (IFPP) could be a promising treatment for spondylolysis in young athletes. Spondylolysis is a stress fracture in the lower back. Studies suggest that this program might be a well-tolerated method for managing this condition. Previous research described the program as a good option, showing potential for managing active spondylolysis.

Although detailed safety information about this program is limited, its testing in clinical settings suggests a certain level of safety and tolerability. As a pilot study, it aims to assess the program's practicality and safety before larger studies are conducted. In the IFPP, participants begin physical therapy soon after diagnosis, rather than waiting for pain to subside. This early intervention is believed to improve movement and possibly reduce long-term issues.

This approach is still under study, and ongoing research will provide more information about its safety and effectiveness. Prospective participants should discuss with their doctor how this program might fit into their treatment plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Immediate Functional Progression Program for spondylolysis because it allows athletes to start physical therapy almost immediately after diagnosis, which is a big shift from the usual "rest until pain resolves" approach. While traditional treatments often require athletes to wait until their pain subsides before beginning physical therapy, this program introduces exercises early, aiming to maintain function and potentially speed up recovery. This proactive approach can help athletes return to their sport faster and with potentially better outcomes, as it focuses on progressing through functional stages rather than just waiting for pain to disappear.

What evidence suggests that the Immediate Functional Progression Program is effective for treating spondylolysis?

Research shows that the Immediate Functional Progression Program (IFPP), which participants in this trial may receive, can help treat spondylolysis in young athletes. Studies have found that starting physical therapy immediately and progressing based on individual performance leads to faster improvements in pain and movement. In one study, 90% of participants showed healing in the affected area within three months. Most participants also reported significant improvements by the end of the program. These findings suggest that IFPP may help young athletes return to sports more quickly and with better results. ^{1 2 4 5 6}

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

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]

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]

Citations

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pubmed.ncbi.nlm.nih.gov

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Immediate functional progression program in adolescent ...

All participants demonstrated marked improvements in pain and function by the end of the program. One participant (8%) had an adverse reaction during care with ...

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Study Details | NCT05505981 | An Immediate Functional ...

The IFPP is a systematic rehabilitation program divided into three phases to allow adolescent athletes with an active spondylolysis to begin exercise ...

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apta.confex.com

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An Immediate Functional Progression Program for ...

Conclusions: Starting PT immediately and progressing based on function ability (IFPP group) resulted in significantly quicker improvements in pain and ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1466853X21001437

Immediate functional progression program in adolescent ...

90% of participants demonstrated healing of spondylolytic lesion at three months. Abstract. Objective. To assess the preliminary evidence for the efficacy and ...

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nationwidechildrens.org

nationwidechildrens.org/-/media/nch/specialties/sports-pt/w1442050-clinical-therapies_sopt_spondylosis-protocol_oct-2024_interactive.pdf

Immediate Functional Progression Program for ...

Immediate Functional Progression Program (IFPP). Athletes with an active spondylolysis randomized into the IFPP group will be referred to physical therapy (PT).

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7872438/

An Alternative Model of Care for the Treatment ...

This pilot study demonstrated that the physical therapist guided functional progression program may be a viable method for treating young athletes with LBP.