NCT06666608

Bone Stimulator for Spondylolysis

The Efficacy of Bone Stimulator in Treatment and Return-to-Sport for Spondylolysis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Spondylolysis
• Symptomatic Spondylolysis
• Athletes

Interventions

Type	Name	Description
DEVICE	Bone Stimulator	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.
OTHER	Standard of Care Spondylolysis Treatment	Participants will follow the standard of care regimen for spondylolysis treatment at Houston Methodist which will involve physical therapy and wearing a back brace.

Timeline

• Start date: 2025-12-03
• Primary completion: 2027-12-01
• Completion: 2029-12-01
• First posted: 2024-10-30
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study