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

NCT ID: NCT03399968

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-26
• Study Completion Date: 2020-05-31

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ESWT

Application of shockwaves non-invasively at the level of injury

Group Type: EXPERIMENTAL

ESWT

Intervention Type: DEVICE

at low energy, shockwaves are applied non-invasively at the injury level and 5 segments up and down of the spinal cord paravertebrally left and right

Placebo ESWT

Positioning of the therapy head at the injury level without application of shockwaves

Group Type: PLACEBO_COMPARATOR

Placebo ESWT

Intervention Type: DEVICE

the ESWT therapy head is positioned at the level of injury and is moved up and down identically as described in the Verum intervention group (ESWT) but without application of shockwaves. The sound which is normally produced by shockwave generation is played by high quality sound recordings in the same amount as in the Verum group

Interventions

ESWT

at low energy, shockwaves are applied non-invasively at the injury level and 5 segments up and down of the spinal cord paravertebrally left and right

Intervention Type: DEVICE

Placebo ESWT

the ESWT therapy head is positioned at the level of injury and is moved up and down identically as described in the Verum intervention group (ESWT) but without application of shockwaves. The sound which is normally produced by shockwave generation is played by high quality sound recordings in the same amount as in the Verum group

Intervention Type: DEVICE

Other Intervention Names

Extracorporeal shockwave therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AUVA Trauma Center Meidling

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AUVA Rehabilitation Center Weisser Hof

Klosterneuburg, Lower Austria, Austria

Site Status: RECRUITING

AUVA Rehabilitation Center Tobelbad

Haselsdorf, Styria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Wolfgang Schaden, MD

Role: CONTACT

wolfgang.schaden@auva.at

+435939320100

Rainer Mittermayr, MD

Role: CONTACT

Rainer.Mittermayr@auva.at

+435939345000

Facility Contacts

Karin Gstaltner, MD

Role: primary

+435939351000

Renate Wildburger, MD

Role: primary

+435939353000

Other Identifiers

ESWT_SCI/1.9-2014

Identifier Type: -

Identifier Source: org_study_id