Bone Stimulator for Spondylolysis

NCT06666608 | Recruiting FDA Device

• 1 other identifier: PRO00038514
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondylolysis; Symptomatic Spondylolysis; Athletes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Level of pain

  Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline

• 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

Other Outcomes (1)

• Physical Therapy Attendance

  Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline

Study Arms (2)

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.

Device: Bone Stimulator

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.

Other: Standard of Care Spondylolysis Treatment

Interventions

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.

Bone Stimulator Treatment

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.

Standard of Care Treatment

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Spondylolysis

Condition Hierarchy (Ancestors)

Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Mark Prasarn, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Goble, MHA

CONTACT

713-441-3930; hmgoble@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)