CompletedNot Applicable

ESWT as a Treatment for Chronic NHO in TBI Patients

Israel12 participantsStarted 2014-10

Plain-language summary

Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured (TBI) patients Chronic Neurogenic Heterotopic Ossification (NHO) - Heterotopic ossification is a well known late complication of traumatic brain injury. Extracorporeal Shock Wave Therapy - ESWT- is used in various medical situations and is being tested for feasibility of use in TBI patients.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years * Brain injured patients with a diagnosis of NHO around the hip and/ or knee for a period of greater than one year. * Patients who are able, or legal guardians who are willing, to provide informed consent after both oral and written information. Exclusion Criteria: * Pregnancy. * Rheumatoid arthritis, ankylosing spondylitis, or femoral neck fractures * Elevated serum alkaline phosphatase (SAP) levels and/or evidence of active bone remodelling in bone scan

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Visual Analogue Scale (VAS) from baseline to final assessment

Timeframe: VAS will be assessed at two weekly intervals from week 0 (Baseline) until week 22, at week 26 and at week 38.

Trial details

NCT IDNCT02331628

SponsorLoewenstein Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-13

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