Houston Methodist Hospital
Houston, Texas, 77030, United States
Location status: Recruiting
NCT Number: NCT06666608
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.
Interested in participating?
Request Info16 year–40 year
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants will follow the standard of care regimen for spondylolysis treatment at Houston Methodist which will involve physical therapy and wearing a back brace.
Time frame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
This outcome will be evaluated via REDCap with a Return to Sport Questionnaire, which will ask what sport(s) participant played prior to injury, if they have returned to the sports they played prior to back injury, what level of sports they returned to (recreational, organized, professional), what level of play they have returned to (same as before injury, higher than before injury, or lower than before injury), and if they report that they did not return to sport, what the reason was. This outcome will also be evaluated by the Tegner Activity Level, which will ask participants to rate their highest level of activity they participated in before their injury and at the current moment on a scale of 0 to 10 where 0 is sick leave or disability pension because of spine problems and 10 is competitive sports at the national elite level.
Time frame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Pain levels will be assessed with the visual analog scale, which asks patients to place a mark on a scale from no pain to worst possible pain level where they think their pain level is best represented.
Time frame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Pain levels will be assessed with one question on the Oswestry Disability Index which asks about a subjective rating of pain intensity from "I have no pain at the moment" to "the pain is the worst imaginable at the moment."
Time frame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
This outcome will be measured with the Oswestry Disability Index which asks participants to rate various aspects of their lives with subjective measures on how they are faring with daily tasks such as personal care, lifting, walking, sitting, social life, travel, etc. This scale consists of ten questions which are each scored from 0 to 5. A higher total cumulative score reflects worse outcomes with 81-100% indicating a participant is bedbound, and lower scores indicating better outcomes with 0-20% reflecting little hindrance to ability to cope with daily life.
Time frame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Attendance at physical therapy will be tracked through EPIC as part of study participation.
Contact information is provided by the study sponsor or research team.
The Methodist Hospital Research Institute
Other
The Efficacy of Bone Stimulator in Treatment and Return-to-Sport for Spondylolysis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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