Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Stimulator Treatment | Experimental | 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. |
|
| Standard of Care Treatment | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Stimulator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Therapy Attendance | Attendance at physical therapy will be tracked through EPIC as part of study participation. | Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haley Goble, MHA | Contact | 713-441-3930 | hmgoble@houstonmethodist.org |
| Name | Affiliation | Role |
|---|---|---|
| Mark Prasarn, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| ID | Term |
|---|---|
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of Care Spondylolysis Treatment | Other | Participants will follow the standard of care regimen for spondylolysis treatment at Houston Methodist which will involve physical therapy and wearing a back brace. |
|
| 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." |
| Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline |
| 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. | Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline |