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Immediate Physical Therapy for Spondylolysis

N/A

Recruiting

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 3 months, 6 months, 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new rehabilitation strategy, the immediate functional progression program (IFPP), for treating active spondylolysis in adolescent athletes. The goal is to see if it is more effective than the current standard of care, which is to wait until the pain has resolved before starting physical therapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't detailed, tolerability between immediate physical therapy and delayed treatment post-pain resolution will be compared. Potential side effects may include discomfort from exercise or issues related to untreated prolonged rest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 months, 6 months, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 3 months, 6 months, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months, 6 months, 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Micheli Functional Scale (MFS)

Change in Quality of Life

Change in edema on MRI

+1 more

Secondary study objectives

Change in Cross Sectional Area of Lumbar Multifidus

Change in Depressive Symptoms

Change in Fear Avoidance Beliefs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate Functional Progression GroupExperimental Treatment1 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 GroupActive Control1 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.

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