Bone Stimulator for Spondylolysis

Overseen By Haley 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 Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a bone stimulator to determine its effectiveness for individuals with spondylolysis, particularly athletes. Researchers aim to discover if this device can reduce pain, improve movement, aid bone healing, and expedite athletes' return to sports. Participants will either use the bone stimulator alongside standard treatments, such as physical therapy and a back brace, or receive only the standard treatments. The trial seeks active individuals diagnosed with spondylolysis who regularly play sports. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve recovery options for athletes.

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 prior data suggests that this bone stimulator is safe for treating spondylolysis?

Research has shown that bone stimulators are generally safe and easy to use. Studies have found no major differences in side effects, such as pain or disability, when comparing these devices to other treatments. This indicates that bone stimulators do not add extra risk. However, the safety of using electrical stimulation in children or those still growing remains unconfirmed. Overall, for adults, these devices are considered safe, with no major side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for spondylolysis involve wearing a back brace and participating in physical therapy. However, the bone stimulator offers a new approach by using electrical stimulation to promote bone healing. Researchers are excited because this device can be worn at rest for just 30 minutes a day, potentially speeding up recovery and improving outcomes compared to traditional methods. Plus, the device tracks usage, allowing for better monitoring of patient compliance.

What evidence suggests that the bone stimulator is effective for spondylolysis?

This trial will compare the use of a bone stimulator with standard care for spondylolysis. Studies have shown promising results for bone stimulators in treating this condition. In some cases, patients using bone growth stimulation, such as electric and pulsed electromagnetic fields, reported excellent outcomes. Research indicates that about 78% of patients experienced no pain and could return to full activities after using a bone stimulator. Additionally, electrical stimulation has successfully healed both one-sided and two-sided spondylolysis. While not everyone achieves complete bone healing, many still see good results, suggesting that this treatment could effectively improve pain and function. ^{4 6 7 8 9}

Who Is on the Research Team?

Mark Prasarn, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

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

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

I plan to attend all my physical therapy sessions.

Exclusion Criteria

I cannot use bone stimulator therapy due to health reasons.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Bone Stimulator Treatment Experimental Treatment 1 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 Treatment Active Control 1 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.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4993622/

Athletic Population with Spondylolysis: Review of ... Two case reports used bone growth stimulation in the form of electric and pulsed electromagnetic field. Both studies showed excellent results.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1529943022001681

Management of lumbar spondylolysis in the adolescent ... Excellent or good results with no pain and return to full activities were seen in 78% of these patients [31]. The use of external bone stimulator was associated ...

3. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/37470-spondylolysis

Spondylolysis | Published in Orthopedic Reviews Prior cases have also cited significant success in healing of both unilateral and bilateral spondylolysis with use of electrical stimulation ...

4. spine.org spine.org/Portals/0/assets/downloads/PolicyPractice/CoverageRecommendations/Elect-Stim-Bone-Healing-71524-DRAFT.pdf

Electrical Stimulation for Bone Healing - DRAFT Clearly, there are patients that do not achieve successful bone fusion by radio- graphic criteria yet obtain good outcomes. Until this issue is resolved, the ...

5. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-09219-1

Comparative outcomes of motion-preserving techniques for ... Conclusions. This study demonstrates that all three surgical techniques—MST, PSS, and DSC—are effective in improving pain and functional ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230025B.pdf

Summary of Safety and Effectiveness Data (SSED) The Xstim Spine Fusion Stimulator promotes bone healing by passing a specific current between the patient electrodes, which generates a low-energy electrical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12577074/

Comparative outcomes of motion-preserving techniques for ... Symptomatic lumbar spondylolysis often disables young athletes. We compared three motion-preserving techniques—modified Scott (MST), pedicle ...

8. aetna.com aetna.com/cpb/medical/data/300_399/0343.html

Bone Growth Stimulators - Medical Clinical Policy Bulletins No differences in adverse events or clinical outcomes (pain, disability) were observed between groups, indicating that PEMF is safe but may only accelerate, ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1466853X21001437

Immediate functional progression program in adolescent ... 90% of participants demonstrated healing of spondylolytic lesion at three months. Abstract. Objective. To assess the preliminary evidence for the efficacy and ...