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NCT Number: NCT06666608

Bone Stimulator for Spondylolysis

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.

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Key information

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Haley Goble, MHA

CONTACT

[email protected]

713-441-3930

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Time to Return to Sport After Diagnosis of Spondylolysis and Bone Healing

    Time frame: 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 outcomes

  1. Level of pain

    Time frame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline

    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.

  2. Level of pain

    Time frame: 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."

  3. Effect on Daily Life

    Time frame: 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.

Other outcomes

  1. Physical Therapy Attendance

    Time frame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline

    Attendance at physical therapy will be tracked through EPIC as part of study participation.

Study contacts

Contact information is provided by the study sponsor or research team.

Haley Goble, MHA

CONTACT

[email protected]

713-441-3930

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

The Efficacy of Bone Stimulator in Treatment and Return-to-Sport for Spondylolysis

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Oct 30, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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