Bone Stimulator for Spondylolysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-40
SponsorThe Methodist Hospital Research Institute
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bone Stimulator
DeviceSubjects 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 Spondylolysis Treatment
Other interventionParticipants will follow the standard of care regimen for spondylolysis treatment at Houston Methodist which will involve physical therapy and wearing a back brace.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Bone Stimulator TreatmentExperimental treatment 1 intervention
Group B: Standard of Care TreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to Return to Sport After Diagnosis of Spondylolysis and Bone Healing
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 baselineSecondary outcomes
1
Level of pain
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 baseline2
Level of pain
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 baseline3
Effect on Daily Life
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 baselineOther outcomes
1
Physical Therapy Attendance
Attendance at physical therapy will be tracked through EPIC as part of study participation.
Time frame
Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baselineSponsors and contacts
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Source ClinicalTrials.gov