Bone Stimulator for Spondylolysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Spondylolysis Symptomatic Spondylolysis Athletes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bone Stimulator

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Standard of Care Spondylolysis Treatment

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No