NCT02331628

ESWT as a Treatment for Chronic NHO in TBI Patients

Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Loewenstein Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PROTOCOL SYNOPSIS Title Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured (TBI) patients. The investigators primary objective is to determine whether Extracorporeal Shock Wave Therapy (ESWT) is effective in reducing pain and improving function in people with traumatic brain injury who have heterotopic ossification around the hip or knee. The investigators hypothesize that four applications of ESWT to the affected hip or knee joint in the patient group will demonstrate a positive physiological effect and this will lead to a reduction in pain and improved function.

Conditions

• TBI Traumatic Brain Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-09-13
• Completion: 2018-09-13
• First posted: 2015-01-06
• Last updated: 2021-02-21

Locations

1 site across 1 country: Israel