Bone Stimulator for Spondylolysis

Not Applicable

Not yet recruiting

• Conditions: Spondylolysis; Symptomatic Spondylolysis; Athletes

• Registration Number: NCT06666608
• Lead Sponsor: The Methodist Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-29
• Study First Posted: 2024-10-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Study Start: 2025-12
• Primary Completion: 2027-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Level of pain	Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline	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."
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.

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States