Extracorporeal Shockwave Therapy (ESWT) to Improve Function in Chronic ASIA-A Patients

Not Applicable

• Conditions: Spinal Cord Injuries
• Interventions: Device: ESWT; Device: Placebo ESWT

• Registration Number: NCT03399968
• Lead Sponsor: AUVA Trauma Center Meidling

Brief Summary

The global prevalence of spinal cord injury is estimated between 236 to 4187/Million. A spontaneous recovery of the sense-motoric function is decreasing with the time after injury and is only seen sporadically after 1 to 2 years. Treatment options are mainly limited to improvement of the quality of life.

The present prospective randomized study is intended as a double-blind, placebo controlled multi-center investigation. Patients suffering from chronic paraplegia (lesion between THII and THX, ASIA A = complete central lesion) at least for 1 year after the initial trauma without spontaneous remission of the last 6 months are considered to be included in the study. Meeting the inclusion criteria and signing the informed consent, patients are treated in one of the two study centers. At study inclusion, a baseline evaluation comprising neurological, neurophysiological, functional and clinical investigation is performed. Patients dedicated to the ESWT intervention group will be treated once a week over 6 weeks with local non-invasive low energy extracorporeal shockwave therapy (=6 treatments with an electrohydraulic device). The follow-up will include neurological, neurophysiological, clinical as well as functional evaluation at the time points 6 weeks, 3 months and 6 months. Additionally, patients will be provided with a diary for documentation of drug adaptation, grade of spasticity and pain. Those patients dedicated to the Placebo ESWT group, will receive the identical scheme in treatment (but without application of shockwaves) and follow-up as the patients in the ESWT group. However, after positive completion of the study, these patients will be offered ESWT as well.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-26
• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05
• Primary Completion: 2019-12-31
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• patients with a spinal cord injury classified as ASIA A between the level of THII to THX (complete central lesion)
• at least 1 year after trauma
• no signs of spontaneous recovery over the last 6 months
• signed informed consent

Exclusion Criteria

• central therapies over the last 6 months (eg stem cells, electro-therapy)
• Baclofen pump
• Joint contraction lower limb > 40° (hip or knee)
• Body weight > 135 kg
• Body height > 202 cm
• non-compliant patients
• Decubital ulcers at grade II or higher
• participation in an other clinical trial within the last 6 months
• Co-morbidities which make study completion doubtful or impossible
• Additional neurological diseases which may lead to further damage to the nerval system
• Malignant tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESWT	ESWT	Application of shockwaves non-invasively at the level of injury
Placebo ESWT	Placebo ESWT	Positioning of the therapy head at the injury level without application of shockwaves

Primary Outcome Measures

Name	Time	Method
Motor function	24 weeks	Motor function of the lower limbs assessed by gait analysis tool (Lokomat (R))

Secondary Outcome Measures

Name	Time	Method
Sensitivity and Motor function	24 weeks	Assessment of levels by the ASIA score ASIA score - a neurologic assessment for patients with spinal cord injury developed by the American Spinal Injury Association.; Examination includes the pin-prick discrimination assessment at 28 specific sensory locations bilaterally but also 10 muscles bilaterally.; Sensory levels for each dermatome (nt...not testable, 0...absent sensation, 1...present sensation but impaired, 2...normal) Motor function of 5 upper extremity and 5 lower extremity key muscles (0...complete paralysis, 1...palpable or visible contraction, 2...active movement, full range of motion, gravity eliminated, 3...active movement, full range of motion, against gravity, 4...active movement, full range of motion, against gravity and provides some resistance, 5...active movement, full range of motion, against gravity and provides normal resistance, nt...not testable)
Spasticity	24 weeks	Evaluation of spasticity degree assessed by the Tardieu test (muscle resistance to passive movement at both slow and fast speed) 2 measurements are performed: 1. Quality of muscle reaction; 2. Angle of muscle reaction 3 speed definitions: 1) V1 is slow as possible 2) V2 speed of limb falling under gravity 3) V3 moving as fast as possible Quality of Muscle Reaction (scored 0-5); 0 is no resistance to passive ROM to 5 indicating joint is immobile (Some versions scored 0-4).
Lung function	24 weeks	Assessment of lung function by peak flow measurements
Trunk control	24 weeks	evaluation of trunk control by the modified functional reach test and Ott test
Quality of life	24 weeks	Assessed by the disability scale SCIM (spinal cord independence measure); Subscores include self-care (range von 0-20 points), respiration and sphincter management (range from 0-40), and mobility (range from 0-40); In total scale range from 0-100 (0 = total dependence, 100 = complete independence).

Trial Locations

Locations (2)

AUVA Rehabilitation Center Tobelbad; 🇦🇹 Haselsdorf, Styria, Austria

AUVA Rehabilitation Center Weisser Hof; 🇦🇹 Klosterneuburg, Lower Austria, Austria