Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing
NCT ID: NCT02586142
Last Updated: 2015-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
30 participants
INTERVENTIONAL
2010-08-31
2013-07-31
Brief Summary
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1. assess the efficiency of BTX-A injection under ultrasonographyic guidance on improving lower extremities function, pain and spasticity in patients with symptomatic claw toes.
2. assess if regular stretching exercise can strength the efficiency of BTX-A injection on improving lower extremities function, pain and spasticity.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Botulinum toxin type A(BTX-A) injection
To inject Botulinum toxin type A on the spasticity lower extremities for participants by ultrasounds guidance.
Botulinum Toxin Type A
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
BTX-A injection plus stretching exercise
Inject Botulinum toxin type A on the spasticity lower extremity for participants by ultrasounds guidance. After injection, arrange them to receive stretching exercise in Kaoshiung Chang Gung Memorial Hospital 3 time per week for 3 months.
Botulinum Toxin Type A
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
Stretching exercise
After accepting Botulinum toxin type A injection, participants will be arranged to receive stretch exercise in Kaohsiung Chang Gung Memorial Hospital 3 times per week, for 3 month.
Interventions
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Botulinum Toxin Type A
To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
Stretching exercise
After accepting Botulinum toxin type A injection, participants will be arranged to receive stretch exercise in Kaohsiung Chang Gung Memorial Hospital 3 times per week, for 3 month.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* MAS scale of metatarsophalange joint and interphalangeal joint more than 2
* Pain during walking, abnormal gait patterns and can't wear shoess due to claw toe
* Haven't received botox or phenol or alcohol injections before
Exclusion Criteria
* Had received botox injections or phenol injections or before due to lower extremities spasticity
* Combine other neuromuscular system disease
* Severe cognition disorder or aphasia after stroke
* Significant atrophy of flexor digitorum longus and brevis
* Allergy to botox
* Infection on injection site
* Have systemic infection
* Now accept aminioglycoside or other medicine will affect neuromusclar transition
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Pong Ya-Ping, MD
Role: STUDY_CHAIR
Rehabilitation
Locations
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Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Countries
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References
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Yelnik AP, Bonan IV. [Post stroke hemiplegia: lower limb benefit from botulinum toxin (review)]. Ann Readapt Med Phys. 2003 Jul;46(6):281-5. doi: 10.1016/s0168-6054(03)00111-9. French.
Rivera-Dominguez M, DiBenedetto M, Frisbie JH, Rossier AB. Pes cavus and claw toes deformity in patients with spinal cord injury and multiple sclerosis. Paraplegia. 1979 Feb;16(4):375-82. doi: 10.1038/sc.1978.71.
Mizel MS, Yodlowski ML. Disorders of the Lesser Metatarsophalangeal Joints. J Am Acad Orthop Surg. 1995 May;3(3):166-173. doi: 10.5435/00124635-199505000-00006.
Feeney MS, Williams RL, Stephens MM. Selective lengthening of the proximal flexor tendon in the management of acquired claw toes. J Bone Joint Surg Br. 2001 Apr;83(3):335-8. doi: 10.1302/0301-620x.83b3.11506.
Boulton AJ. Pressure and the diabetic foot: clinical science and offloading techniques. Am J Surg. 2004 May;187(5A):17S-24S. doi: 10.1016/S0002-9610(03)00297-6.
Myerson MS, Shereff MJ. The pathological anatomy of claw and hammer toes. J Bone Joint Surg Am. 1989 Jan;71(1):45-9.
Truckenbrodt H, Hafner R, von Altenbockum C. Functional joint analysis of the foot in juvenile chronic arthritis. Clin Exp Rheumatol. 1994 Sep-Oct;12 Suppl 10:S91-6.
Cyphers SM, Feiwell E. Review of the Girdlestone-Taylor procedure for clawtoes in myelodysplasia. Foot Ankle. 1988 Apr;8(5):229-33. doi: 10.1177/107110078800800501.
Bernbach EH, Bernbach MR. A box joint arthrodesis for the proximal interphalangeal joint in claw toe deformity. J Am Podiatr Med Assoc. 1985 Nov;75(11):575-80. doi: 10.7547/87507315-75-11-575. No abstract available.
Gracies JM, Elovic E, McGuire J, Simpson DM. Traditional pharmacological treatments for spasticity. Part I: Local treatments. Muscle Nerve Suppl. 1997;6:S61-91.
Gajiwala KJ, Sams SB, Pandya N, Wagh A. A new dynamic lumbrical simulating splint for claw hand deformity. Plast Reconstr Surg. 1991 Jan;87(1):170-3. doi: 10.1097/00006534-199101000-00030.
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.
O'Brien CF. Treatment of spasticity with botulinum toxin. Clin J Pain. 2002 Nov-Dec;18(6 Suppl):S182-90. doi: 10.1097/00002508-200211001-00011.
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Korelitz BI, Sommers SC. Responses to drug therapy in ulcerative colitis. Evaluation by rectal biopsy and histopathological changes. Am J Gastroenterol. 1975 Nov;64(5):365-70.
Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.
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.
Suputtitada A. Local botulinum toxin type A injections in the treatment of spastic toes. Am J Phys Med Rehabil. 2002 Oct;81(10):770-5. doi: 10.1097/00002060-200210000-00009.
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.
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.
O'Brien CF. Injection techniques for botulinum toxin using electromyography and electrical stimulation. Muscle Nerve Suppl. 1997;6:S176-80.
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.
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Rivest J, Lees AJ, Marsden CD. Writer's cramp: treatment with botulinum toxin injections. Mov Disord. 1991;6(1):55-9. doi: 10.1002/mds.870060110.
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Other Identifiers
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NMRPG890041
Identifier Type: -
Identifier Source: org_study_id
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