Bone stimulator treatment for spondylolysis in athletes
The Efficacy of Bone Stimulator in Treatment and Return-to-Sport for Spondylolysis
This project will test whether adding a bone stimulator to usual care helps athletes aged 16 to 40 with symptomatic spondylolysis reduce pain, improve function, heal the bone, and return to sport sooner.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 16 Years to 40 Years |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06666608 on ClinicalTrials.gov |
What this trial studies
This is a prospective interventional study enrolling athletes with symptomatic spondylolysis who will receive bone stimulation in addition to standard-of-care treatment and prescribed physical therapy, compared with those receiving standard care alone. Investigators will track outcomes including pain scores, functional improvement, radiographic osseous union, and time to return to sport. Key eligibility includes ages 16–40, regular sports participation, and ability to attend physical therapy, while exclusions include prior spine surgery, pacemaker/ICD, metabolic bone disease, nicotine use, and other contraindications. The study is conducted at Houston Methodist Hospital and targets athletic populations to define the adjunct role of bone stimulation for pars defects.
Who should consider this trial
Good fit: Ideal candidates are athletes aged 16 to 40 with symptomatic spondylolysis who can attend prescribed physical therapy and have no contraindications to bone stimulation.
Not a fit: Patients with prior spine surgery, implanted cardiac devices, metabolic bone disease, nicotine use, or other contraindications are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding bone stimulation could speed bone healing, reduce pain, and shorten time to return to sport for athletes with spondylolysis.
How similar studies have performed: Bone stimulators have demonstrated benefit for certain fractures and nonunions, but data specifically for spondylolysis in athletes are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between the ages of 16 to 40 years of age diagnosed with symptomatic spondylolysis by one of the investigators * Patients who plan to attend prescribed physical therapy * Patients who participate in a regular sport whether that be professional, collegiate or recreational Exclusion Criteria: * Any condition which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions * Patients with contraindications to bone stimulator therapy * Patients with pacemaker and implantable cardioverter defibrillator * Patients with previous spine surgery * Patients with metabolic bone conditions * Patients who use nicotine products * Vulnerable populations * Non-English speaking services
Where this trial is running
Houston, Texas
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Mark Prasarn, MD — The Methodist Hospital Research Institute
- Study coordinator: Haley Goble, MHA
- Email: hmgoble@houstonmethodist.org
- Phone: 713-441-3930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.