Clinical Trial: ESWT as a Treatment for Chronic NHO in TBI Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured Patients
Brief 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 Summary:
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.
Sponsor: Loewenstein Hospital
Current Primary Outcome: Change in Visual Analogue Scale (VAS) from baseline to final assessment [ Time Frame: VAS will be assessed at two weekly intervals from week 0 (Baseline) until week 22, at week 26 and at week 38. ]
Original Primary Outcome:
- Change from Visual Analogue Scale (VAS) at baseline [ Time Frame: VAS will be assessed at two weekly intervals from week 0 (Baseline) until week 22, at week 26 and at week 38. ]The Visual Analogue Pain Scale (VAS) will be used in its format of the Faces Rating Scale (FRS). The VAS has been established as reliable and valid in clinical research by a number of authors (Hawker, Mian, Kendzerska, & French, 2011; McCormack, Horne, & Sheather, 1988). 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.
- Change from The 10 Metre Walk at baseline [ Time Frame: If patient is ambulatory: At baseline;week 16,26 and 38 ]
Temporal and Distance Measures (Velocity, Stride Length, Cadence) will be measured using the 10 metre walk test and the 6 -minute walk test (6MWT). These tests are simple, quick and can be used with minimal equipment. They have been shown to be reliable and valid in monitoring improvements in both in TBI and TSCI patient groups(Rossier & Wade, 2001; Van Hedel, Wirz, & Dietz, 2005; van Loo, Moseley, Bosman, De Bie, & Hassett, 2004; Wall, Devlin, Khirchof, & Lackey, 2000).
Test procedure for 10m walk:
The patient stands at one end of the walkway, and uses their regular walking aid. Given the following instructions; "Walk at your comfortable walking speed to the other end of this walkwa
Current Secondary Outcome:
- Change from the 10 Metre Walk at baseline (if patient is ambulatory) [ Time Frame: At baseline; weeks 16, 26 and 38 ]Temporal and distance measures (velocity, stride length, cadence) will be measured using the 10 metre walk test.
- Change from the 6 Minute Walk at baseline (if patient is ambulatory) [ Time Frame: At baseline; weeks 16, 26 and 38 ]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.
- Change from Functional Reach at baseline (if patient is able to stand) [ Time Frame: Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38 ]
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.
- Change from Modified Functional Reach at baseline (if FR not possible) [ Time Frame: Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38 ]
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.
Original Secondary Outcome:
- Change from 6 Minute Walk Test at baseline [ Time Frame: If patient is ambulatory: At baseline;16 weeks,26 weeks and 38 weeks ]
Test procedure for 6MWT:
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. The therapist should avoid giving motivational feedback. If the patient needs to stop, rest periods are included in the measurement time.
- Range of Motion will be assessed every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38 [ Time Frame: At Baseline and every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38 ]Range of motion (ROM) is a description of how much movement exists at a joint. Joint ROM can be assessed through a variety of methods, but in this trial ROM will be measured using a universal goniometer, using the protocol described by Clarkson (2005). A goniometer is a device used to measure joint angles or range-of-motion (in degrees) of joints for either active or passive joint range. Although inter-rater reliability of goniometric measures of ROM has been found to be poor (van Trijffel, van de Pol, Oostendorp, & Lucas, 2010), intra-rater reliability has been found to be good in the clinical setting in both the hip and the knee joints (Boone et al., 1978; Holm et al., 2000; Rothstein, Miller, & Roettger, 1983)
Information By: Loewenstein Hospital
Dates:
Date Received: December 16, 2014
Date Started: October 2014
Date Completion: December 2017
Last Updated: September 26, 2016
Last Verified: September 2016
- Change from the 10 Metre Walk at baseline (if patient is ambulatory) [ Time Frame: At baseline; weeks 16, 26 and 38 ]
