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

NCT03399968 | Unknown DMC

• 1 other identifier: ESWT_SCI/1.9-2014
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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

Keywords

shockwave; ESWT

Outcome Measures

Primary Outcomes (1)

• Motor function

  Motor function of the lower limbs assessed by gait analysis tool (Lokomat (R))

  24 weeks

Secondary Outcomes (5)

• Sensitivity and Motor function

  24 weeks

• Spasticity

  24 weeks

• Trunk control

  24 weeks

• Lung function

  24 weeks

• Quality of life

  24 weeks

Study Arms (2)

ESWT

EXPERIMENTAL

Application of shockwaves non-invasively at the level of injury

Device: ESWT

Placebo ESWT

PLACEBO COMPARATOR

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

Device: Placebo ESWT

Interventions

ESWT 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

Also known as: Extracorporeal shockwave therapy

ESWT

Placebo ESWT 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

Placebo ESWT

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AUVA Trauma Center Meidling: lead

Study Sites (2)

AUVA Rehabilitation Center Weisser Hof

Klosterneuburg, Lower Austria, 3400, Austria

RECRUITING

AUVA Rehabilitation Center Tobelbad

Haselsdorf, Styria, 8144, Austria

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Wolfgang Schaden, MD

CONTACT

+435939320100; wolfgang.schaden@auva.at

Rainer Mittermayr, MD

CONTACT

+435939345000; Rainer.Mittermayr@auva.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized controlled double blinded clinical intervention study

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: March 26, 2015
• Primary Completion: December 31, 2019
• Study Completion: May 31, 2020
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)