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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonography direct-guidance | Experimental | To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance. |
|
| Electric stimulation | Experimental | To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Electric stimulation |
|
| Surface anatomy landmark | Active Comparator | To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Surface anatomy landmark. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Brunnstrome Stage | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Condition at 6 months |
| Active Range of Motion | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pong Ya-Ping, MD | Contact | 889-7-7317123 | 6286 | yaping0707@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pong Ya-Ping, MD | Rehabilitation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 475355 | Background | 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. | |
| 9826984 | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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|
| Change from Baseline Data at 6 months |
| 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 |
| 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 |
| 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 |
| Barthel Index | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 9826983 | 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. |
| 12569963 | 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. |
| 15201348 | Background | Jankovic J. Botulinum toxin in clinical practice. J Neurol Neurosurg Psychiatry. 2004 Jul;75(7):951-7. doi: 10.1136/jnnp.2003.034702. |
| 21045798 | 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. |
| 12167681 | 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. |
| 17617291 | 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. |
| 8857723 | 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. |
| 11022071 | 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. |
| 17285183 | 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. |
| 15832139 | 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. |
| 11889247 | 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. |
| 16198612 | 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. |
| 9826989 | Background | O'Brien CF. Injection techniques for botulinum toxin using electromyography and electrical stimulation. Muscle Nerve Suppl. 1997;6:S176-80. |
| 20797552 | 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. |
| 14738817 | 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. |
| 16785117 | 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. |
| 18560136 | 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. |
| 20659720 | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |