SpondylolysisNCT06666608
Bone Stimulator for Spondylolysis
A study testing Bone Stimulator in people with Spondylolysis and Symptomatic Spondylolysis, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Spondylolysis, Symptomatic Spondylolysis, Athletes
- What is being tested?
- Bone Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Haley Goble, MHA, 713-441-3930, hmgoble@houstonmethodist.org
About this study
Official title: The Efficacy of Bone Stimulator in Treatment and Return-to-Sport 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.
- Conditions
- Spondylolysis, Symptomatic Spondylolysis, Athletes
- Being tested
- Bone Stimulator, Standard of Care Spondylolysis Treatment
- Medical subject headings
- Spondylolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone StimulatorDevice
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 TreatmentOther
Participants will follow the standard of care regimen for spondylolysis treatment at Houston Methodist which will involve physical therapy and wearing a back brace.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care Spondylolysis Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Secondary outcomes (3)
Level of pain
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.
Measured: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Level of pain
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."
Measured: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Effect on Daily Life
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.
Measured: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start3 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Prasarn, The Methodist Hospital Research Institute
- Investigators
- Mark Prasarn, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666608
- Sponsor's protocol ID
- PRO00038514
- Status last verified
- Mar 2026
- First submitted
- 28 Oct 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Bone Stimulator in Treatment and Return-to-Sport for Spondylolysis
- ClinicalTrials.gov ID
- NCT06666608
- Acronym / sponsor ID
- PRO00038514
- Conditions
- Spondylolysis, Symptomatic Spondylolysis, Athletes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone Stimulator Treatment | Experimental | Device: Bone StimulatorIn 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. |
| Standard of Care Treatment | Active comparator | Other: Standard of Care Spondylolysis TreatmentParticipants assigned to this group will undergo the standard of care treatment for spondylosis which is physical therapy and the usage of a back brace. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone StimulatorSubjects 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. | Device | Bone Stimulator Treatment |
| Standard of Care Spondylolysis TreatmentParticipants will follow the standard of care regimen for spondylolysis treatment at Houston Methodist which will involve physical therapy and wearing a back brace. | Other | Standard of Care Treatment |
Primary outcome
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.
3 secondary outcomes
Level of pain
Time frame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Level of pain
Time frame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Effect on Daily Life
Time frame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Prasarn, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Stimulator in people with Spondylolysis and Symptomatic Spondylolysis, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Goble, MHA (713-441-3930, hmgoble@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026; AzTrials last refreshed its copy on 29 Oct 2026.