Recruiting

Bone Stimulator

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06666608

Conditions

Spondylolysis

Symptomatic Spondylolysis

Athletes

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Not accepted

Interventions

Bone Stimulator

Standard of Care Spondylolysis Treatment

Study Details

Brief 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

Study ID

NCT06666608

Start date

Dec 3, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

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 and Locations

Central contacts

Haley Goble, MHA

713-441-3930hmgoble@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Haley Goble, MHA

713-441-3930hmgoble@houstonmethodist.org

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-03-25.