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ESWT as a Treatment for Chronic NHO in TBI Patients

Primary Purpose

TBI Traumatic Brain Injury

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

ESWT - Extracorporeal Shockwave Therapy

About this trial

This is an interventional treatment trial for TBI Traumatic Brain Injury focused on measuring TBI Traumatic Brain Injury, HO Heterotopic Ossification, NHO Neurogenic Heterotopic Ossification, ESWT Extracorporeal Shock Wave Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Loewenstein Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

ESWT - Extracorporeal Shockwave Therapy

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT02331628

First Posted

December 16, 2014

Last Updated

February 17, 2021

Sponsor

Loewenstein Hospital

Collaborators

James Cook University, Queensland, Australia, University of Melbourne, Medispec

1. Study Identification

Unique Protocol Identification Number

NCT02331628

Brief Title

ESWT as a Treatment for Chronic NHO in TBI Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

September 13, 2018 (Actual)

Study Completion Date

September 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Loewenstein Hospital

Collaborators

James Cook University, Queensland, Australia, University of Melbourne, Medispec

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

TBI Traumatic Brain Injury

Keywords

TBI Traumatic Brain Injury, HO Heterotopic Ossification, NHO Neurogenic Heterotopic Ossification, ESWT Extracorporeal Shock Wave Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Arm Title

ESWT - Extracorporeal Shockwave Therapy

Arm Type

Experimental

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

ESWT - Extracorporeal Shockwave Therapy

Other Intervention Name(s)

Minispec™ extracorporeal shockwave therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Visual Analogue Scale (VAS) from baseline to final assessment

Description

Time Frame

VAS will be assessed at two weekly intervals from week 0 (Baseline) until week 22, at week 26 and at week 38.

Secondary Outcome Measure Information:

Title

Change from the 10 Metre Walk at baseline (if patient is ambulatory)

Description

Temporal and distance measures (velocity, stride length, cadence) will be measured using the 10 metre walk test.

Time Frame

At baseline; weeks 16, 26 and 38

Title

Change from the 6 Minute Walk at baseline (if patient is ambulatory)

Description

Time Frame

At baseline; weeks 16, 26 and 38

Title

Change from Functional Reach at baseline (if patient is able to stand)

Description

Time Frame

Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38

Title

Change from Modified Functional Reach at baseline (if FR not possible)

Description

Time Frame

Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38

Other Pre-specified Outcome Measures:

Title

Change from Functional Independence Measure (FIM) at baseline

Description

The Functional Independence Measure (FIM) assesses physical and cognitive disability. It consists of two subscales, motor and socio-cognitive with 18 assessable items in total. The tool is completed by observation of performance. The motor subscale, which is the portion to be assessed in this trial includes 13 items: eating, grooming bathing, dressing upper extremity, dressing lower extremity, bowel management, bladder management, transfers to bed, chair or wheelchair, transfer to tub, toilet and shower, walking or wheelchair propulsion and stair climbing. Each item is scored on a 7 point ordinal scale ranging from 1 (total dependence) to a score of 7 (total independence). Motor FIM scores range from 13 (total dependence) to 91 (total independence). Reliability and validity is well-established. The FIM has been translated into 10 languages, including English and Hebrew, the languages to be used in this study.

Time Frame

At baseline; then at 8, 16, 26 and 38 weeks

Title

Range of Motion

Description

Range of Motion (ROM) of the affected hip and knee will be measured using a universal goniometer, using the protocol described by Clarkson (2005).

Time Frame

Every two weeks from week 0 up to week 22; then at weeks 26 and 38

Title

Change from The European Quality Of Life -Dimensions questionnaire (EQ-5D) at baseline

Description

The European Quality Of Life -Dimensions questionnaire (EQ-5D) is a standardised generic instrument designed for describing and valuing health by providing a single summary index value representing the overall health-related quality of life of an individual by quantifying a preference for his or her health state. The EQ-5D instrument consists of a self-classifier/ descriptive system to describe the respondent's own health in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents can value their health in each dimension at three ordinal levels: no problems, some or moderate problems, and severe or extreme problems. The second measurement component of the EQ-5D is a 20 cm vertical Visual Analogue Scale (EQ VAS) to rate the respondent's own health. The third component of the EQ-5D is a questionnaire on the respondent's background including medical history.

Time Frame

At baseline; 16,26 and 38 weeks

Title

Change from Plain X-ray at baseline

Description

Neurogenic Heterotopic Ossification (NHO) becomes evident on plain radiography approximately 2 to 6 weeks after clinical diagnosis (Freed, Hahn, Menter, & Dillon, 1982; Orzel & Rudd, 1985). An X-ray view will be set up for each patient and recorded so that it can be repeated. The view does not need to be a standard view; it is the patient's particular view that is important and reproducible. Measurements will be made along co-ordinates - set up for that patient - e.g. the largest and shortest diameters. Plain X-ray will be taken pre-intervention and six months post-intervention. Changes in the size of NHO will be calculated using UTHSCSA ImageTool (2002).plain radiography .

Time Frame

At baseline and six months post first intervention

Title

Change from Serum Alkaline Phosphatase Levels (SAP) at baseline

Description

Overview Alkaline Phosphatase Uses Preparation Procedure Risks Results More on Healthline Part 1 of 7: Overview What Is an Alkaline Phosphatase Level Test? An alkaline phosphatase level test (ALP test) measures the amount of alkaline phosphatase enzyme in your bloodstream. The test requires a simple blood draw and is often a routine part of other blood tests.

Time Frame

At base line, week 12, week 16, week 38

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yaron Sacher, MD

Organizational Affiliation

Loewenstein Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loewenstein Rehabilitation Center

City

Ra'anana

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

28340308

Citation

Reznik JE, Biros E, Lamont AC, Sacher Y, Kibrik O, Milanese S, Gordon S, Galea MP. A preliminary investigation on the effect of extracorporeal shock wave therapy as a treatment for neurogenic heterotopic ossification following traumatic brain injury. Part I: Effects on pain. Brain Inj. 2017;31(4):526-532. doi: 10.1080/02699052.2017.1283059. Epub 2017 Mar 24.

Results Reference

result

PubMed Identifier

28340312

Citation

Reznik JE, Biros E, Sacher Y, Kibrik O, Milanese S, Gordon S, Galea MP. A preliminary investigation on the effect of extracorporeal shock wave therapy as a treatment for neurogenic heterotopic ossification following traumatic brain injury. Part II: Effects on function. Brain Inj. 2017;31(4):533-541. doi: 10.1080/02699052.2017.1283060. Epub 2017 Mar 24.

Results Reference

result

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ESWT as a Treatment for Chronic NHO in TBI Patients

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