What this study is
This prospective study aims to investigate the effectiveness of bone stimulator therapy as adjunct treatment of spondylolysis in athletic populations. By evaluating its impact on pain reduction, functional improvement, osseous bony union and return-to-sport time, the investigators seek to provide valuable insights into the role of bone stimulation therapy as a potential treatment modality for this challenging condition.
What's being tested
- Bone Stimulator
Intervention · DEVICE
Subjects will be asked to wear their device (if applicable) for a minimum of 30 minutes a day for 12 weeks with no maximum usage time. The device will track compliance. Bone stimulator should be worn at rest.
- Standard of Care Spondylolysis Treatment
Intervention · OTHER
Participants will follow the standard of care regimen for spondylolysis treatment at Houston Methodist which will involve physical therapy and wearing a back brace.
Study details
- Official title
- The Efficacy of Bone Stimulator in Treatment and Return-to-Sport for Spondylolysis
- Sponsor
- The Methodist Hospital Research Institute
- Conditions
- Spondylolysis · Symptomatic Spondylolysis · Athletes
- Enrolling
- 48 people
- Starts
- 2025-12-03
- Est. completion
- 2029-12
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 16 Years – 40 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openHouston Methodist Hospital
Houston, Texas, United States
- Haley Goble, MHA · Contact713-441-3930hmgoble@houstonmethodist.org
Recruiting
Study team
Sponsor
The Methodist Hospital Research Institute
Study ID PRO00038514
Principal investigator
Mark Prasarn, MD
The Methodist Hospital Research Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.