TBI Traumatic Brain InjuryNCT02331628
ESWT as a Treatment for Chronic NHO in TBI Patients
A study testing ESWT - Extracorporeal Shockwave Therapy in people with TBI Traumatic Brain Injury, run by Loewenstein Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TBI Traumatic Brain Injury
- What is being tested?
- ESWT - Extracorporeal Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to 13 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured Patients
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.
Read the 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
- Being tested
- ESWT - Extracorporeal Shockwave Therapy
- Keywords
- TBI Traumatic Brain Injury, HO Heterotopic Ossification, NHO Neurogenic Heterotopic Ossification, ESWT Extracorporeal Shock Wave Therapy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWT - Extracorporeal Shockwave TherapyDevice
Also called Minispec™ 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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care only will be provided during Baseline period and Follow-up period. |
| ESWT - Extracorporeal Shockwave Therapy | Experimental | 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). Receives: Device: ESWT - Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: VAS will be assessed at two weekly intervals from week 0 (Baseline) until week 22, at week 26 and at week 38.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startOct 2014
- Primary completion13 Sep 2018
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TBI Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- James Cook University, Queensland, Australia, University of Melbourne, Medispec
- Responsible party
- Principal investigator, yaron sacher, Loewenstein Hospital
- Investigators
- Yaron Sacher, MD, Principal investigator, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331628
- Sponsor's protocol ID
- 20-13
- Status last verified
- Feb 2021
- First submitted
- 16 Dec 2014
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28340308Reznik 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.
PubMed 28340312
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured Patients
- ClinicalTrials.gov ID
- NCT02331628
- Acronym / sponsor ID
- 20-13
- Conditions
- TBI Traumatic Brain Injury
- Keywords
- TBI Traumatic Brain Injury, HO Heterotopic Ossification, NHO Neurogenic Heterotopic Ossification, ESWT Extracorporeal Shock Wave Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Collaborators
- James Cook University, Queensland, Australia, University of Melbourne, Medispec
- Study start
- Oct 2014
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care only will be provided during Baseline period and Follow-up period. |
| ESWT - Extracorporeal Shockwave Therapy | Experimental | Device: ESWT - Extracorporeal Shockwave TherapyParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESWT - Extracorporeal Shockwave TherapyAlso: Minispec™ extracorporeal shockwave therapyPatients 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. | Device | ESWT - Extracorporeal Shockwave Therapy |
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.
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.
4 secondary outcomes
Change from the 10 Metre Walk at baseline (if patient is ambulatory)
Time frame: At baseline; weeks 16, 26 and 38
Change from the 6 Minute Walk at baseline (if patient is ambulatory)
Time frame: At baseline; weeks 16, 26 and 38
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Results publication: PubMed 28340308Reznik 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 publication: PubMed 28340312Reznik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Sacher, MD principal investigator
Loewenstein Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT - Extracorporeal Shockwave Therapy in people with TBI Traumatic Brain Injury, run by Loewenstein Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02331628, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.