Extracorporeal Shockwave Therapy (ESWT) for the Management of Stress Fractures and High-grade Bone Stress Injuries (BSIs)

Conditions

• Bone Stress Fracture
• Bones Stress Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Extracorporeal shockwave treatment (ESWT). — DEVICE
  Extracorporeal shockwave treatment is a therapeutic modality that uses focused shockwaves through an electrohydraulic process that uses higher energy per unit area.
• Sham Device — DEVICE
  The sham device (placebo) will be used in correlation with the standard of care procedures.

Study Details

The goal of this clinical trial is to evaluate the clinical safety and efficacy of Extracorporeal Shockwave Therapy (ESWT) for the management of high-grade Bone Stress Injuries (BSIs) in collegiate and recreational athletes compared to a control group receiving standard of care with sham ESWT. The primary and secondary endpoints of the study are to evaluate the safety and feasibility of extracorporeal shockwave therapy for the treatment of pelvic and lower limb extremity fracture or BSI. Researchers will compare the ESWT group to the sham ESWT group to see if ESWT results in better safety and efficacy outcomes for treating high-grade BSIs. Participants will: * Undergo a screening period to determine eligibility. * Receive up to 4 treatment sessions of ESWT, with the frequency of sessions being approximately every 5 days (within a range of every 3-10 days). * Be monitored for up to 6 months for research follow-up, with further questionnaires and check-ins during the standard of care follow-up period until they are able to return to sport activity level.

Key Dates

First listed

Sep 24, 2024

Start date

May 1, 2025

Status verified

Jul 2026

Primary completion

May 1, 2027

Completion

Nov 1, 2027

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Standard of Care + ESWT
  Participants in this arm will be receiving Extracorporeal shockwave treatment, supplementing their standard of care.
• Placebo Comparator: Standard of Care + Sham Device
  Participants in this arm will be receiving the sham device mimicking extracorporeal shockwave treatment, supplementing their standard of care.

Primary Outcome Measure

Primary Outcome [ Time Frame: From baseline to the end of treatment at up to 8 months ]

Central Contacts

• Perion L Smith
  310-592-0008
  [email protected]
• Debbie J Argueta Rufino
  310-210-6829
  [email protected]

Locations (4)

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