The Efficacy of Bone Stimulator in Treatment and Return-to-Sport for Spondylolysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Time to Return to Sport After Diagnosis of Spondylolysis and Bone Healing
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Bone Stimulator Treatment
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.
干预措施: Bone Stimulator (Device)
Standard of Care Treatment
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.
干预措施: Standard of Care Spondylolysis Treatment (Other)
结局指标
主要结局
Time to Return to Sport After Diagnosis of Spondylolysis and Bone Healing
时间窗: 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.
次要结局
- 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)
研究者
Mark Prasarn
Orthopedic Surgeon
The Methodist Hospital Research Institute