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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
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 moreSecondary 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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Who is running the clinical trial?
Nationwide Children's HospitalLead Sponsor
348 Previous Clinical Trials
5,227,750 Total Patients Enrolled
Children's Hospital ColoradoOTHER
120 Previous Clinical Trials
5,133,131 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I feel numbness or tingling in my lower back area.I have been diagnosed with active spondylolysis confirmed by MRI.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.I had to rest for more than 4 weeks due to lower back pain.I am between 10 and 19 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Rest until pain resolves Group
- Group 2: Immediate Functional Progression Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.