Clinical trial NCT02331628: 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
Overall status: COMPLETED
Phase: NA
Conditions: TBI Traumatic Brain Injury
Keywords: TBI Traumatic Brain Injury
HO Heterotopic Ossification
NHO Neurogenic Heterotopic Ossification
ESWT Extracorporeal Shock Wave Therapy
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
Collaborators: name: James Cook University, Queensland, Australia
name: University of Melbourne
name: Medispec
First posted: 2015-01-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Visual Analogue Scale (VAS) from baseline to final assessment
timeFrame: VAS will be assessed at two weekly intervals from week 0 (Baseline) until week 22, at week 26 and at week 38.
Secondary outcomes:
measure: Change from the 10 Metre Walk at baseline (if patient is ambulatory)
timeFrame: At baseline; weeks 16, 26 and 38
measure: Change from the 6 Minute Walk at baseline (if patient is ambulatory)
timeFrame: At baseline; weeks 16, 26 and 38
measure: Change from Functional Reach at baseline (if patient is able to stand)
timeFrame: Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38
measure: Change from Modified Functional Reach at baseline (if FR not possible)
timeFrame: Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38
Other outcomes:
measure: Change from Functional Independence Measure (FIM) at baseline
timeFrame: At baseline; then at 8, 16, 26 and 38 weeks
measure: Range of Motion
timeFrame: Every two weeks from week 0 up to week 22; then at weeks 26 and 38
measure: Change from The European Quality Of Life -Dimensions questionnaire (EQ-5D) at baseline
timeFrame: At baseline; 16,26 and 38 weeks
measure: Change from Plain X-ray at baseline
timeFrame: At baseline and six months post first intervention
measure: Change from Serum Alkaline Phosphatase Levels (SAP) at baseline
timeFrame: At base line, week 12, week 16, week 38
Locations:
city: Ra'anana
country: Israel
facility: Loewenstein Rehabilitation Center
Study officials:
affiliation: Loewenstein Hospital
name: Yaron Sacher, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.