The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex
NCT ID: NCT03860662
Last Updated: 2021-06-18
Study Results
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Basic Information
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COMPLETED
PHASE4
29 participants
INTERVENTIONAL
2018-05-26
2019-04-21
Brief Summary
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Detailed Description
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The objective of spasticity treatment minimizes the negative effects of hypertension without endangering function. Systematic medication treatment (baclofen, diazepam, dantrolen, and tizanidine) or local treatment (botulinum toxin, phenyl injection) are administered in spasticity treatment. The botulinum toxin prevents the secretion of acetylcholine in nerve endings and creates a presynaptic neuromuscular block. There are numerous studies that show that botulinum toxin is effective in spasticity.
Baclofen is a gamma aminobutyric acid (GABA) agonist. It passes through the blood-brain barrier and binds to the GABAb receptors of the spinal cord. Baclofen decreases spasms, clonus, and resistance to germs.
Various studies of electrophysiological reflexes are conducted to evaluate spasticity and to study neuronal circuits. The electrophysiological test is a tool used in studying the changes in spinal cord function and spinal reflexes in patients. The flexor reflex known as the recoil reflex is a polysynaptic and multisegmental reflex. It provides for avoidance and protection from internal and external stimulants that may be harmful for the body.
The purpose of the study is to research the effect of oral baclofen treatment and botulinum toxin injection treatments over the electromyographic nociceptive flexor reflex (NFR) threshold in hemiplegic patients with spasticity.
PURPOSE OF THE RESEARCH The purpose of this thesis is to research the effect of oral baclofen treatment and botulinum toxin injection treatments over the electromyographic nociceptive flexor reflex (NFR) threshold in hemiplegic patients with spasticity. The results of the study evaluated the Modified Ashworth Scale, joint range of motion, muscle strength, Brunnstrom stages, Barthel daily life activities index, electromyographic nociceptive flexor reflex (NFR) threshold
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Spastic hemiplegia , Botox
Botulinum toxin (BTX), being one of the most potent biological toxins, acts by blocking neuromuscular transmission via inhibiting acetylcholine release. Currently, focal spasticity is being treated successfully with BTX via injecting in the spastic muscles( Dose: 300-400 iu). Two antigenically distinct serotypes of BTX are available on the market as type A and B.
Nociceptor flexor reflex
The nociceptive flexion reflex (NFR) is a physiological, polysynaptic reflex allowing for painful stimuli to activate an appropriate withdrawal response
Botox
botox
Spastic hemiplegia, Baclofen
Baclofen is an agonist that has presynaptic and postsynaptic effects on monosynaptic and polysynaptic pathways by binding to GABA B receptors. The recommended dosing regimen is initiated with 5 mg 3 times a day. It can be increased by 15-mg/d increments at 3-day intervals as needed. Dosing should not exceed 80 mg/d.
Nociceptor flexor reflex
The nociceptive flexion reflex (NFR) is a physiological, polysynaptic reflex allowing for painful stimuli to activate an appropriate withdrawal response
Baclofen
baclofen
Interventions
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Nociceptor flexor reflex
The nociceptive flexion reflex (NFR) is a physiological, polysynaptic reflex allowing for painful stimuli to activate an appropriate withdrawal response
Botox
botox
Baclofen
baclofen
Eligibility Criteria
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Inclusion Criteria
* To accept voluntary participation in the study
* Spastic Hemiplegia (Modified Ashworth Scale 2 and above)
Exclusion Criteria
* To have medication and substance use causing neuropathy in the history of the disease and / or neuropathy
* Companies that have received botulinum toxin injection therapy and / or oral antispastic therapy within the last 6 months
* Have a history of allergies and hypersensitivity to usability drug
* Injection treatment planned purification hematoma, cleaning or skin lesion to be
18 Years
60 Years
ALL
Yes
Sponsors
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Mustafa Kemal University
OTHER
Responsible Party
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ERTURK GUNTURK
research assistant doctor
Locations
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Hatay Mustafa Kemal University
Hatay, , Turkey (Türkiye)
Countries
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Other Identifiers
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MustafaKUPMR
Identifier Type: -
Identifier Source: org_study_id
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