ESWT as a Treatment for Chronic NHO in TBI Patients

NCT02331628 | Completed DMC

• 1 other identifier: 20-13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI Traumatic Brain Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  At baseline; weeks 16, 26 and 38

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

  At baseline; weeks 16, 26 and 38

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

  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)

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

Other Outcomes (5)

• Change from Functional Independence Measure (FIM) at baseline

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

• Range of Motion

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

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

  At baseline; 16,26 and 38 weeks

Study Arms (2)

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).

Device: ESWT - Extracorporeal Shockwave Therapy

Interventions

ESWT - Extracorporeal Shockwave Therapy 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.

Also known as: Minispec™ extracorporeal shockwave therapy

ESWT - Extracorporeal Shockwave Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Loewenstein Hospital: lead
• James Cook University, Queensland, Australia: collaborator
• University of Melbourne: collaborator
• Medispec: collaborator

Study Sites (1)

Loewenstein Rehabilitation Center

Raanana, Israel

Location

Related Publications (2)

• 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.

  PMID: 28340308 RESULT

• 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.

  PMID: 28340312 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Yaron Sacher, MD

  Loewenstein Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yaron Sacher M.D

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 6, 2015
• Study Start: October 1, 2014
• Primary Completion: September 13, 2018
• Study Completion: September 13, 2018
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

IL (1)