ESWT as a Treatment for Chronic NHO in TBI Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-09-13

Brief Summary

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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.

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Detailed Description

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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

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TBI Traumatic Brain Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Usual care only will be provided during Baseline period and Follow-up period.

Group Type NO_INTERVENTION

No interventions assigned to this group

ESWT - Extracorporeal Shockwave Therapy

Participants will receive 4 applications of extracorporeal shockwave therapy to the affected hip and/or knee over a period of 8 weeks (one dose every 2 weeks).

Group Type EXPERIMENTAL

ESWT - Extracorporeal Shockwave Therapy

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Minispec™ extracorporeal shockwave therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No