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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Micheli Functional Scale (MFS)

Change in Quality of Life

Change in edema on MRI

+1 more

Secondary outcome measures

Change in Cross Sectional Area of Lumbar Multifidus

Change in Depressive Symptoms

Change in Fear Avoidance Beliefs

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,446 Total Patients Enrolled

Children's Hospital ColoradoOTHER

116 Previous Clinical Trials

5,132,555 Total Patients Enrolled

Media Library

Immediate Functional Progression Program Clinical Trial Eligibility Overview. Trial Name: NCT05505981 — N/A

Lumbar Spondylosis Research Study Groups: Rest until pain resolves Group, Immediate Functional Progression Group

Lumbar Spondylosis Clinical Trial 2023: Immediate Functional Progression Program Highlights & Side Effects. Trial Name: NCT05505981 — N/A

Immediate Functional Progression Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05505981 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the general public engaging in this clinical experiment?

"Affirmative. The clinical trial's webpage found on the website of clinicaltrials.gov reveals that it is actively seeking candidates since its initiation on August 22nd 2022 and most recently updated on the same day. In total, 60 patients need to be recruited between two medical sites."

Answered by AI

Who are the eligible participants in this experiment?

"Eligible participants must have a diagnosis in the lumbar region, and be between 10 to 19 years old. This research is currently accepting approximately 60 patients."

Answered by AI

Is this research recruiting participants at the moment?

"Affirmative. According to the information provided on clinicaltrials.gov, this trial is actively looking for participants since it was initially posted on August 22nd 2022 and recently updated on that same date. A total of 60 patients are needed across two medical centres."

Answered by AI