Bone Stimulator for Spondylolysis

The Methodist Hospital Research Institute (TMHRI)

Status: Enrolling

Conditions: Athletes; Spondylolysis; Symptomatic Spondylolysis

Treatments: Other: Standard of Care Spondylolysis Treatment; Device: Bone Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT06666608

PRO00038514

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Bone Stimulator Treatment

Experimental group

Description:

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.

Treatment:

Device: Bone Stimulator

Standard of Care Treatment

Active Comparator group

Description:

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.

Treatment:

Other: Standard of Care Spondylolysis Treatment