Clinical Trial Finder

Bone Stimulator for Spondylolysis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 16 Years - 40 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06666608
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 The Methodist Hospital Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Mark Prasarn, MD
Principal Investigator Affiliation The Methodist Hospital Research Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Spondylolysis, Symptomatic Spondylolysis, Athletes
Arms & Interventions

Arms

Experimental: Bone Stimulator Treatment

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.

Active Comparator: Standard of Care Treatment

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.

Interventions

Device: - Bone 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.

Other: - Standard 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Houston Methodist Hospital, Houston, Texas

Status

Address

Houston Methodist Hospital

Houston, Texas, 77030

Site Contact

Haley Goble, MHA

[email protected]

713-441-3930

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