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ESWT as a Treatment for Chronic NHO in TBI Patients

NCT02331628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-02-21

No results posted yet for this study

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.

Conditions

  • TBI Traumatic Brain Injury

Interventions

DEVICE

ESWT - Extracorporeal Shockwave Therapy

Patients will receive: * Four applications of EWST to be delivered to the affected hip and /or knee over a period of eight weeks : starting week 8\\52 from baseline until and including week 14\\52, one dose every two weeks ± 3 days), administered by the principal investigator. * Dosage will be calculated for each participant, by the manufacturer, according to the size of NHO as recorded on X-ray. * The energy flux density (EFD) will be 'high level' * All participants will be supplied with headphones to reduce the noise level emitted by the machine.

Sponsors & Collaborators

  • James Cook University, Queensland, Australia

    collaborator OTHER

  • University of Melbourne

    collaborator OTHER

  • Medispec

    collaborator INDUSTRY

  • Loewenstein Hospital

    lead OTHER

Principal Investigators

  • Yaron Sacher, MD · Loewenstein Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-09-13
Completion
2018-09-13

Countries

  • Israel

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02331628 on ClinicalTrials.gov