NCT02203994

Brief Summary

Spasticity is the most problematic self-reported secondary medical problem in patients with spinal cord injury. It has the potential to negatively influence quality of life through restricting activities of daily living. Problematic spasticity can cause pain and fatigue, disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a negative effect on patients morbidity. For this reason there is enormous interest in therapeutic interventions addressing to decrease spasticity in persons with spinal cord injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no studies are published, assessing the effect of extracorporeal shock wave therapy on focal spasticity in patients with spinal cord injury. The purpose of this study is to investigate the effect of a one-time ESWT on lower limb spasticity in patients with an incomplete spinal cord injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

July 28, 2014

Last Update Submit

January 25, 2017

Conditions

Spinal Cord InjurySpasticity

Keywords

extracorporal shock wave therapy (ESWT)spasticityspinal cord injury

Outcome Measures

Primary Outcomes (1)

  • severity of spasticity

    Ashworth Scale

    time 0, time 2h

Secondary Outcomes (7)

  • personal goal attainment

    at day 0, 1, 3 and 5

  • walking speed

    difference between pre- and post-intervention

  • walking distance

    difference between pre- and post-intervention

  • thickness of the treated muscle

    difference between pre- and post-intervention

  • severity of spasticity

    time 0, time 2h

  • +2 more secondary outcomes

Study Arms (1)

extracorporeal shock wave therapy (ESWT)

EXPERIMENTAL

one-time treatment of the spastic muscle/ spastic muscles (adductor muscles and/ or M. triceps surae) with extracorporeal shock wave therapy (device: Duolith® SD 1 "T-Top" (Storz Medical AG, Tägerwilen, Switzerland))

Device: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)

Interventions

Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)DEVICE

2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz

extracorporeal shock wave therapy (ESWT)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Traumatic or non traumatic spinal cord injury
  • Minimum age: 18 years
  • Minimum time since spinal cord injury: two years
  • Lesion: C3-Th10
  • American Association of Spinal Cord Injury Impairment Score C and D
  • Focal spasticity in the adductor muscles and/ or triceps surae
  • Ability to walk 14 meters
  • Spasticity/clonus/spasms disturbing the activities of daily living or participation

You may not qualify if:

  • Changes in spasticity medication during the last 3 months
  • Treatment with botulinum toxin during the last 6 months
  • Anticoagulant medication
  • Thrombosis
  • Malignant tumors
  • Pregnancy
  • Inflammations or skin lesions in the treated area
  • Acute urinary tract infection
  • Intended change in spasticity medication within 5 days after intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord InjuriesMuscle Spasticity

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Baumberger, Dr. med.

    Swiss Paraplegic Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 30, 2014

Study Start

July 1, 2014

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

CH(1)