Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities

NCT02557737 | Unknown Phase 3

• 1 other identifier: CMRPG8B0222
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study were to compare the injection locations of key spastic muscles on upper extremity by three different guidance localization methods ( surface anatomy landmark, ultrasonography, electric stimulation) and the effectiveness.

Conditions

Cerebrovascular Accident

Keywords

stroke; upper extremity; spasticity; botulinum toxin; ultrasonography; electric stimulation

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth Scale

  patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection

  Change from Baseline Muscle Tone at 6 months

Secondary Outcomes (13)

• Brunnstrome Stage

  Change from Baseline Condition at 6 months

• Active Range of Motion

  Change from Baseline Data at 6 months

• 4 Point Categorical Pain Intensity Scale

  Change from Baseline Data at 6 months

• Hand-grasp strength Assessment

  Change from Baseline Data at 6 months

• Pinch Strength Assessment

  Change from Baseline Data at 6 months

Study Arms (3)

Ultrasonography direct-guidance

EXPERIMENTAL

To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance.

Drug: Botulinum Toxin Type A

Electric stimulation

EXPERIMENTAL

To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Electric stimulation

Drug: Botulinum Toxin Type A

Surface anatomy landmark

ACTIVE COMPARATOR

To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Surface anatomy landmark.

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A DRUG

To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance, Ultrasonography direct-guidance, Electric stimulation and Surface anatomy landmark.

Also known as: Botulinum toxin

Electric stimulation; Surface anatomy landmark; Ultrasonography direct-guidance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• first onset.
• at least onset before 6 months.
• elbow, wrist and fingers are above Modified Ashworth Scale(MAS) 1+.
• Mini-Mental State Exam above 24.
• can follow all of the follow up and instruction.
• patients never accept botox, phenol and alcohol injections before.

You may not qualify if:

• contracture deformity on upper extremity.
• patients had accepted botox before or had have phenol, alcohol injections and operation 6 months ago.
• allergy to botox.
• have neither infection nor skin disorder on inject site.
• now accept aminoglycoside or other medicine treatment which may affect neuromuscular transition.
• combine other systemic disease of neurological or skelectomuscular system
• cognition disorder or aphasia after stroke.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Related Publications (20)

• Mizrahi EM, Angel RW. Impairment of voluntary movement by spasticity. Ann Neurol. 1979 Jun;5(6):594-5. doi: 10.1002/ana.410050620. No abstract available.

  PMID: 475355 BACKGROUND

• Gracies JM, Nance P, Elovic E, McGuire J, Simpson DM. Traditional pharmacological treatments for spasticity. Part II: General and regional treatments. Muscle Nerve Suppl. 1997;6:S92-120.

  PMID: 9826984 BACKGROUND

• Gracies JM, Elovic E, McGuire J, Simpson DM. Traditional pharmacological treatments for spasticity. Part I: Local treatments. Muscle Nerve Suppl. 1997;6:S61-91.

  PMID: 9826983 BACKGROUND

• Difazio M, Jabbari B. A focused review of the use of botulinum toxins for low back pain. Clin J Pain. 2002 Nov-Dec;18(6 Suppl):S155-62. doi: 10.1097/00002508-200211001-00007.

  PMID: 12569963 BACKGROUND

• Jankovic J. Botulinum toxin in clinical practice. J Neurol Neurosurg Psychiatry. 2004 Jul;75(7):951-7. doi: 10.1136/jnnp.2003.034702.

  PMID: 15201348 BACKGROUND

• Lim EC, Seet RC. Use of botulinum toxin in the neurology clinic. Nat Rev Neurol. 2010 Nov;6(11):624-36. doi: 10.1038/nrneurol.2010.149. Epub 2010 Oct 12.

  PMID: 21045798 BACKGROUND

• Brashear A, Gordon MF, Elovic E, Kassicieh VD, Marciniak C, Do M, Lee CH, Jenkins S, Turkel C; Botox Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002 Aug 8;347(6):395-400. doi: 10.1056/NEJMoa011892.

  PMID: 12167681 BACKGROUND

• Yablon SA, Brashear A, Gordon MF, Elovic EP, Turkel CC, Daggett S, Liu J, Brin MF. Formation of neutralizing antibodies in patients receiving botulinum toxin type A for treatment of poststroke spasticity: a pooled-data analysis of three clinical trials. Clin Ther. 2007 Apr;29(4):683-90. doi: 10.1016/j.clinthera.2007.04.015.

  PMID: 17617291 BACKGROUND

• Yablon SA, Agana BT, Ivanhoe CB, Boake C. Botulinum toxin in severe upper extremity spasticity among patients with traumatic brain injury: an open-labeled trial. Neurology. 1996 Oct;47(4):939-44. doi: 10.1212/wnl.47.4.939.

  PMID: 8857723 BACKGROUND

• Bakheit AM, Thilmann AF, Ward AB, Poewe W, Wissel J, Muller J, Benecke R, Collin C, Muller F, Ward CD, Neumann C. A randomized, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of botulinum toxin type A (Dysport) with placebo in upper limb spasticity after stroke. Stroke. 2000 Oct;31(10):2402-6. doi: 10.1161/01.str.31.10.2402.

  PMID: 11022071 BACKGROUND

• Francisco GE. Botulinum toxin for post-stroke spastic hypertonia: a review of its efficacy and application in clinical practice. Ann Acad Med Singap. 2007 Jan;36(1):22-30.

  PMID: 17285183 BACKGROUND

• Chin TY, Nattrass GR, Selber P, Graham HK. Accuracy of intramuscular injection of botulinum toxin A in juvenile cerebral palsy: a comparison between manual needle placement and placement guided by electrical stimulation. J Pediatr Orthop. 2005 May-Jun;25(3):286-91. doi: 10.1097/01.bpo.0000150819.72608.86.

  PMID: 15832139 BACKGROUND

• Molloy FM, Shill HA, Kaelin-Lang A, Karp BI. Accuracy of muscle localization without EMG: implications for treatment of limb dystonia. Neurology. 2002 Mar 12;58(5):805-7. doi: 10.1212/wnl.58.5.805.

  PMID: 11889247 BACKGROUND

• Lim EC, Ong BK, Seet RC. Botulinum toxin-A injections for spastic toe clawing. Parkinsonism Relat Disord. 2006 Jan;12(1):43-7. doi: 10.1016/j.parkreldis.2005.06.008. Epub 2005 Sep 29.

  PMID: 16198612 BACKGROUND

• O'Brien CF. Injection techniques for botulinum toxin using electromyography and electrical stimulation. Muscle Nerve Suppl. 1997;6:S176-80.

  PMID: 9826989 BACKGROUND

• Alter KE. High-frequency ultrasound guidance for neurotoxin injections. Phys Med Rehabil Clin N Am. 2010 Aug;21(3):607-30. doi: 10.1016/j.pmr.2010.05.001.

  PMID: 20797552 BACKGROUND

• Berweck S, Schroeder AS, Fietzek UM, Heinen F. Sonography-guided injection of botulinum toxin in children with cerebral palsy. Lancet. 2004 Jan 17;363(9404):249-50. doi: 10.1016/S0140-6736(03)15351-2. No abstract available.

  PMID: 14738817 BACKGROUND

• Schroeder AS, Berweck S, Lee SH, Heinen F. Botulinum toxin treatment of children with cerebral palsy - a short review of different injection techniques. Neurotox Res. 2006 Apr;9(2-3):189-96. doi: 10.1007/BF03033938.

  PMID: 16785117 BACKGROUND

• Depedibi R, Unlu E, Cevikol A, Akkaya T, Cakci A, Cerekci R, Kose G, Unlusoy D. Ultrasound-guided botulinum toxin type A injection to the iliopsoas muscle in the management of children with cerebral palsy. NeuroRehabilitation. 2008;23(3):199-205.

  PMID: 18560136 BACKGROUND

• Henzel MK, Munin MC, Niyonkuru C, Skidmore ER, Weber DJ, Zafonte RD. Comparison of surface and ultrasound localization to identify forearm flexor muscles for botulinum toxin injections. PM R. 2010 Jul;2(7):642-6. doi: 10.1016/j.pmrj.2010.05.002.

  PMID: 20659720 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Botulinum Toxins, Type A; Botulinum Toxins

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Pong Ya-Ping, MD

  Rehabilitation

  STUDY CHAIR

Central Study Contacts

Pong Ya-Ping, MD

CONTACT

889-7-7317123; yaping0707@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 23, 2015
• Study Start: September 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 30, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)