Athletes, Spondylolysis, Symptomatic Spondylolysis
Conditions
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.
Interventions
DEVICEBone Stimulator
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.
OTHERStandard of Care Spondylolysis Treatment
Participants will follow the standard of care regimen for spondylolysis treatment at Houston Methodist which will involve physical therapy and wearing a back brace.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Return to Sport After Diagnosis of Spondylolysis and Bone Healing | 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
| Measure | Time frame | Description |
|---|---|---|
| Level of pain | 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. |
| Effect on Daily Life | 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. |
Countries
United States
Contacts
CONTACTHaley Goble, MHA
PRINCIPAL_INVESTIGATORMark Prasarn, MD
The Methodist Hospital Research Institute
Outcome results
None listed