Actively Recruiting
The Efficacy of Bone Stimulator in Treatment and Return-to-Sport for Spondylolysis
Led by The Methodist Hospital Research Institute · Updated on 2026-03-25
48
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of bone stimulator therapy as an additional treatment for spondylolysis in athletes. This study aims to understand how bone stimulation may affect pain relief, functional improvement, bone healing, and the time it takes for athletes to return to sport. The study is sponsored by The Methodist Hospital Research Institute and focuses on a common but challenging condition affecting athletic populations. Participants are randomly assigned to one of two groups. One group receives standard care, which includes wearing a back brace and following a physical therapy regimen. The other group receives this standard care plus a bone stimulator device to wear for at least 30 minutes daily while at rest, for 12 weeks. The device tracks usage to monitor compliance. There is no maximum daily usage time for the bone stimulator. Throughout the study, participants will be evaluated at baseline, 6 weeks, 12 weeks, and 6 months. Researchers will measure the time it takes for participants to return to sport and assess bone healing. They will also monitor pain levels and how the condition affects daily life. The study duration and follow-up visits ensure thorough tracking of treatment effects and participant progress.
CONDITIONS
Brief Title
Bone Stimulator for Spondylolysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 16 to 40 years diagnosed with symptomatic spondylolysis by an investigator
- Patients who plan to attend prescribed physical therapy
- Patients who participate regularly in sports, including professional, collegiate, or recreational levels
You will not qualify if you...
- Conditions that may interfere with the ability to follow study instructions as judged by the investigator
- Contraindications to bone stimulator therapy
- Presence of pacemaker or implantable cardioverter defibrillator
- Previous spine surgery
- Metabolic bone conditions
- Use of nicotine products
- Vulnerable populations
- Non-English speaking individuals requiring services
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 12 weeks
Participants receive either a bone stimulator device to wear at rest for at least 30 minutes daily for 12 weeks along with standard care, or standard care alone involving physical therapy and a back brace.
Visits at baseline, 6 weeks, and 12 weeks after baseline
Duration - Up to 6 months after baseline
Participants are monitored to assess return to sport, pain levels, and effects on daily life after treatment completion.
Visit at 6 months after baseline
Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Haley Goble, MHA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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