The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex

NCT03860662 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: MustafaKUPMR
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Stroke Sequelae; Spastic Hemiplegia

Keywords

Antispastic drugs; Nociceptive flexor reflex; Baclofen; Botulinum toxin

Outcome Measures

Primary Outcomes (5)

• thershold of nociceptive flexor reflex

  The nociceptive flexion reflex (NFR) is a physiological, polysynaptic reflex allowing for painful stimuli to activate an appropriate withdrawal response

  6 weeks

• Barthel index

  The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. The index also indicates the need for assistance in care.The final score on the Barthel index ranges from 0, or complete dependence, to 100, or complete independence .

  6 weeks

• Vısual analog scale

  When using a VAS to assess pain, subjects are asked to indicate intensity by marking a (usually) 100-mm-long horizontal line that is labeled "no pain" at one end and "worst pain possible" at the other end. This requires the patient to be able to equate the length of the line (as measured from the left-hand side to the point marked) with the amount of pain they are experiencing. Higher values represent worse outcome.

  6 weeks

• Range of motion

  Range of motion (ROM) is the measurement of the amount of movement around a specific joint or body part

  6 weeks

• Modified Ashworth scale

  The Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Higher values represent worse outcome. (0) No increase in muscle tone (1) Slight increase in muscle tone, manifested by a catch and release or byminimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension.(1+) Slight increase in muscle tone, manifested by a catch, followed by minimalresistance throughout the remainder (less than half) of the ROM.(2) More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved.(3) Considerable increase in muscle tone, passive movement difficult.(4) Affected part(s) rigid in flexion or extension

  6 weeks

Study Arms (2)

Spastic hemiplegia , Botox

ACTIVE COMPARATOR

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.

Diagnostic Test: Nociceptor flexor reflex; Drug: Botox

Spastic hemiplegia, Baclofen

OTHER

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.

Diagnostic Test: Nociceptor flexor reflex; Drug: Baclofen

Interventions

Nociceptor flexor reflex DIAGNOSTIC_TEST

The nociceptive flexion reflex (NFR) is a physiological, polysynaptic reflex allowing for painful stimuli to activate an appropriate withdrawal response

Spastic hemiplegia , Botox; Spastic hemiplegia, Baclofen

Botox DRUG

botox

Spastic hemiplegia , Botox

Baclofen DRUG

baclofen

Spastic hemiplegia, Baclofen

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 18-60
• To accept voluntary participation in the study
• Spastic Hemiplegia (Modified Ashworth Scale 2 and above)

You may not qualify if:

• Pregnant women, breastfeeding and younger than 18 years
• 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

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia

Interventions

Botulinum Toxins, Type A; Baclofen

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant doctor

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: March 4, 2019
• Study Start: May 26, 2018
• Primary Completion: March 21, 2019
• Study Completion: April 21, 2019
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

TU (1)