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

Cerebrovascular Accident Clinical Trial

Official title:

Comparison of Surface Landmark, Ultrasonography and Electric Stimulation Guidance for Botulinum Toxin Injections in Stroke Patients With Spasticity on Upper Extremities.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02557737
• Other study ID #: CMRPG8B0222
• Status: Recruiting
• Phase: Phase 3
• First received: September 17, 2015
• Last updated: March 28, 2016
• Start date: September 2012
• Est. completion date: July 2016

Study information

• Verified date: March 2016
• Source: Chang Gung Memorial Hospital
• Contact: Pong Ya-Ping, MD
• Phone: 889-7-7317123
• Email: yaping0707[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Stroke may result in acute or chronic hemiplegia and spasticity in stroke patients. Spasticity in upper extremities may interfere with motor voluntary function, activities of daily living and cause muscle pain. Botulinum toxin type A (BTX-A) has been shown to relieve spasticity and pain in upper extremities of stroke patients. There are no researches to compare the efficiency of BTX-A by different injection guidance methods in stroke patients. The aims of our 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. The investigators will enroll 60 hemiplegic stroke patients with upper extremity spasticity more than modified Ashworth scale ( MAS) 1+ and duration more than 6 months. Under different guidance methods (surface anatomy landmark/ ultrasonography /electric stimulation ), BTX-A will be injected to the key spastic muscles on upper extremity. Outcome measures include MAS, motor function ( Brunnstrom stage of upper extremity), range of motion , the degree and visual analog scale of pain , pinch and grasp power，Stroke Impact Scale, Barthel index and upper extremity function (Nine hole peg test，Action Reaearch Arm Test，Wolf Motor Function test，Chedoke Arm and Han Activity Inventory，Fugl-Meyer Assessment Scale，Motor Activity Log). All the assessments will be performed before BTX-A injection and followed up at 4 weeks, 8 weeks, 12 weeks and 24 weeks after injection. After performing all the assessments, investigators will investigate the efficiency of BTX-A by different guidance methods.

Four of arms:

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

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

electric stimulation guidance: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by electric stimulation guidance.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Muscle Spasticity
• Stroke

Intervention

Drug:
• Botulinum Toxin Type A
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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (20)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Depedibi R, Unlü E, Cevikol A, Akkaya T, Cakci A, Cerekçi R, Köse G, Unlüsoy 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. — View Citation

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. Review. — View Citation

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

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

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. Review. — View Citation

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. — View Citation

Jankovic J. Botulinum toxin in clinical practice. J Neurol Neurosurg Psychiatry. 2004 Jul;75(7):951-7. Review. — View Citation

Lim EC, Ong BK, Seet RC. Botulinum toxin-A injections for spastic toe clawing. Parkinsonism Relat Disord. 2006 Jan;12(1):43-7. Epub 2005 Sep 29. — View Citation

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. Review. — View Citation

Mizrahi EM, Angel RW. Impairment of voluntary movement by spasticity. Ann Neurol. 1979 Jun;5(6):594-5. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Brunnstrome Stage	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Condition at 6 months	No
Secondary	Active Range of Motion	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Data at 6 months	No
Secondary	4 Point Categorical Pain Intensity Scale	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Data at 6 months	No
Secondary	Hand-grasp strength Assessment	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Data at 6 months	No
Secondary	Pinch Strength Assessment	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Data at 6 months	No
Secondary	Barthel Index	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Data at 6 months	No
Secondary	Stroke Impact Scale (SIS)	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Data at 6 months	No
Secondary	Action Research Arm Test (ARAT)	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Data at 6 months	No
Secondary	Wolf Motor Function Test	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Data at 6 months	No
Secondary	Chedoke Arm and Hand Activity Inventory (CAHAI)	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Data at 6 months	No
Secondary	Fugl-Meyer Assessment	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Data at 6 months	No
Secondary	Motor Activity Log Scale	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Data at 6 months	No
Secondary	Nine Hole Peg Test	patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection	Change from Baseline Data at 6 months	No