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Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

48 Participants Needed

Bone Stimulator for Spondylolysis

Overseen ByHaley Goble, MHA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Pacemaker, Spine surgery, Nicotine, others

Stay on Your Current MedsYou can continue your current medications while participating

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Bone Stimulator for Spondylolysis?

Research shows that bone growth stimulators, like the one used for spinal fusion, can significantly improve fusion rates. In one study, patients using a bone growth stimulator had an 81% success rate in achieving spinal fusion, compared to 54% without it, suggesting it may help in conditions like spondylolysis.¹ ² ³ ⁴ ⁵

How does the bone stimulator treatment for spondylolysis differ from other treatments?

The bone stimulator treatment for spondylolysis is unique because it uses electrical currents to promote bone growth and fusion, which is different from traditional surgical methods. This approach has shown to significantly increase the success rate of spinal fusion, especially in patients with previous failed fusions or other high-risk factors.¹ ² ⁶ ⁷ ⁸

What is the purpose of this trial?

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.

Research Team

Mark Prasarn, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

This trial is for athletes experiencing back pain due to spondylolysis. Participants should be diagnosed with this condition and seeking additional treatment options beyond standard care.

Inclusion Criteria

I plan to attend all my physical therapy sessions.

Patients who participate in a regular sport whether that be professional, collegiate or recreational

I am between 16 and 40 years old and have been diagnosed with spondylolysis.

Exclusion Criteria

Any condition which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions

Patients with pacemaker and implantable cardioverter defibrillator

Patients who use nicotine products

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bone stimulator therapy as adjunct treatment for 12 weeks

12 weeks

Daily use of bone stimulator for at least 30 minutes

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Visits at baseline, 6 weeks, 12 weeks, and 6 months

Treatment Details

Interventions

Bone Stimulator

Trial Overview The study is testing the effectiveness of a bone stimulator device alongside usual spondylolysis treatments, focusing on pain relief, functional recovery, healing of bones, and how quickly athletes can return to sports.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Bone Stimulator TreatmentExperimental Treatment1 Intervention

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 II: Standard of Care TreatmentActive Control1 Intervention

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.