ESWT as a Treatment for Chronic NHO in TBI Patients

Loewenstein Hospital

Status: Completed

Conditions: TBI Traumatic Brain Injury

Treatments: Device: ESWT - Extracorporeal Shockwave Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02331628

20-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

Control

No Intervention group

Description:

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

ESWT - Extracorporeal Shockwave Therapy

Experimental group

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).

Treatment:

Device: ESWT - Extracorporeal Shockwave Therapy