NCT03131791

Brief Summary

Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 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

April 1, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

April 21, 2017

Last Update Submit

August 17, 2018

Conditions

Post-Stroke Upper Limb Spasticity

Keywords

Extracorporeal Shock WaveSpasticity in stokesBotulinum toxin

Outcome Measures

Primary Outcomes (1)

  • The change of spasticity of elbow

    Modified Ashworth Scale (MAS) for spasticity

    Between baseline and 4 weeks post-treatment

Secondary Outcomes (2)

  • The change of Tardieu scale scores for the elbow and wrist

    Between baseline and 1, 4,8 weeks post-treatment

  • The change of upper limb function

    Between baseline and 1,4,8 weeks post-treatment

Study Arms (2)

shock wave

EXPERIMENTAL

The interventions were focused in the hypertonic muscles of the upper limb of 3000 impulses, a pressure of 1.5 bar and frequency of 5Hz were used to treat the biceps brachii, flexor carpi ulnaris and flexor carpi radialis, mainly in the middle of the belly.

Device: Shock Wave

Botulinum toxin A

EXPERIMENTAL

We performed BoNT-A 500 unit in 2cc 0.9% normal saline at biceps brachii, flexor carpi ulnaris and flexor carpi radialis, mainly in the middle of the belly.

Drug: Botulinum toxin A

Interventions

Shock WaveDEVICE

42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment.

shock wave
Botulinum toxin ADRUG

42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment.

Botulinum toxin A

Eligibility Criteria

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

You may qualify if:

  • Aged between 18-80 year-old
  • The onset of stroke must be at least 6 months previously
  • Spasticity measured as Modified Asthow Scale more(MAS) than 1+
  • Signed informed consent form

You may not qualify if:

  • Patients with marked contractures in the elbow and wrist (MAS\>4)
  • Resistant hypertension, coagulation disorders, malignant tumors, pregnancy, pacemakers, cognitive disorders
  • Prior or planned treatment with phenol or alcohol nerve blocks, intrathecal baclofen, or BoNT-A injection within the six months preceding the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Wu YT, Yu HK, Chen LR, Chang CN, Chen YM, Hu GC. Extracorporeal Shock Waves Versus Botulinum Toxin Type A in the Treatment of Poststroke Upper Limb Spasticity: A Randomized Noninferiority Trial. Arch Phys Med Rehabil. 2018 Nov;99(11):2143-2150. doi: 10.1016/j.apmr.2018.05.035. Epub 2018 Jul 4.

    PMID: 30392753DERIVED

MeSH Terms

Interventions

Extracorporeal Shockwave TherapyBotulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationBotulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: group A : shock wave, group B: Botulinum Toxin Injection
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

April 21, 2017

First Posted

April 27, 2017

Study Start

April 1, 2017

Primary Completion

July 1, 2017

Study Completion

September 30, 2017

Last Updated

August 20, 2018

Record last verified: 2018-08

Locations

TW(1)