The Efficacy of Bone Stimulator in Treatment and Return-to-Sport for Spondylolysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spondylolysis
- Sponsor
- The Methodist Hospital Research Institute
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Time to Return to Sport After Diagnosis of Spondylolysis and Bone Healing
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Investigators
Mark Prasarn
Orthopedic Surgeon
The Methodist Hospital Research Institute
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •Patients with metabolic bone conditions
- •Patients who use nicotine products
- •Vulnerable populations
- •Non-English speaking services
Outcomes
Primary Outcomes
Time to Return to Sport After Diagnosis of Spondylolysis and Bone Healing
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.
Secondary Outcomes
- Level of pain(Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline)
- Effect on Daily Life(Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline)