Bone Stimulator for Spondylolysis

Conditions

• Athletes
• Spondylolysis
• Symptomatic Spondylolysis

Eligibility Criteria

Sex

ALL

Age

16 Years - 40 Years

Healthy Volunteers

Not accepted

Interventions

• Bone Stimulator — 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 — 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

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.

Key Dates

Start date

Dec 3, 2025

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bone Stimulator Treatment
  In addition to the standard of care treatment at Houston Methodist for spondylolysis (provision of a back brace and prescribed physical therapy regimen), participants assigned to this group will be provided a bone stimulator wherein they will be asked to wear their device for a minimum of 30 minutes a day for 12 weeks with no maximum usage time. The device will track compliance, and will be worn when at rest.
• Active Comparator: Standard of Care Treatment
  Participants assigned to this group will undergo the standard of care treatment for spondylosis which is physical therapy and the usage of a back brace.

Primary Outcome Measure

Time to Return to Sport After Diagnosis of Spondylolysis and Bone Healing [ Time Frame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline ]

Central Contacts

• Haley Goble, MHA
  713-441-3930
  [email protected]

Locations (1)

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