ESWT as a Treatment for Chronic NHO in TBI Patients

Study Overview
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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.

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.

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

Conditions
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TBI Traumatic Brain Injury

Intervention / Treatment
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* Device: ESWT - Extracorporeal Shockwave Therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care only will be provided during Baseline period and Follow-up period. | |
| Experimental: ESWT - Extracorporeal Shockwave Therapy<br>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). | Device: ESWT - Extracorporeal Shockwave Therapy<br>* 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.<br>* Other names: Minispec™ extracorporeal shockwave therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogue Scale (VAS) from baseline to final assessment | The Visual Analogue Pain Scale (VAS) will be used in its format of the Faces Rating Scale (FRS). The FRS is in the format of six facial expressions suggesting various pain intensities. The patient will be asked to choose the face that best describes how they feel. The far left face indicates 'No hurt' and the far right face indicates 'Hurts worst'. The number below the face chosen will be documented. | VAS will be assessed at two weekly intervals from week 0 (Baseline) until week 22, at week 26 and at week 38. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from the 10 Metre Walk at baseline (if patient is ambulatory) | Temporal and distance measures (velocity, stride length, cadence) will be measured using the 10 metre walk test. | At baseline; weeks 16, 26 and 38 | 
| Change from the 6 Minute Walk at baseline (if patient is ambulatory) | The patient is positioned at the start of the walking track and given the standardized instructions; Walk as quickly as you can for six minutes to cover as much ground as possible. You may stop if you have to, but continue again as soon as you are able. On the instruction to start the therapist starts the stopwatch. At six minutes the patient is instructed to stop and the distance travelled is calculated. If the patient needs to stop, rest periods are included in the measurement time. | At baseline; weeks 16, 26 and 38 | 
| Change from Functional Reach at baseline (if patient is able to stand) | The patient is instructed to stand next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the starting position at the 3rd metacarpal head on the yardstick. The patient is instructed to Reach as far as you can forward without taking a step. The location of the 3rd metacarpal is recorded. The difference between the start and end position is the reach distance, usually measured in centimeters. Three trials are done and the average of the last two is noted. | Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38 | 
| Change from Modified Functional Reach at baseline (if FR not possible) | Modified Functional Reach (MFR) is a reliable measure of sitting balance for those patients unable to stand. This test is performed with a leveled yardstick mounted on the wall at the height of the patient's acromion level while sitting in a chair. Hips, knees and ankles are positioned at 90 degree of flexion, with feet flat on the floor. The initial reach is measured with the patient sitting against the back of the chair with the arm flexed to 90 degrees. The measurement is taken from the distal end of the third metacarpal along the yardstick. There are three conditions over three trials: Sitting with the arm near the wall and leaning forward Sitting with the back to the wall and leaning right Sitting with the back to the wall leaning left. Instructions are leaning as far as possible in each direction without rotation and without touching the wall. The distance in centimetres covered in each direction will be recorded. | Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HO Heterotopic Ossification, TBI Traumatic Brain Injury, NHO Neurogenic Heterotopic Ossification, ESWT Extracorporeal Shock Wave Therapy