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

Stroke Sequelae Clinical Trial

Official title:

Doctor, Physical Medicine and Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860662
• Other study ID #: MustafaKUPMR
• Status: Completed
• Phase: Phase 4
• Start date: May 26, 2018
• Est. completion date: April 21, 2019

Study information

• Verified date: June 2021
• Source: Mustafa Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Spasticity is defined as increased resistance tied to speed against passive movements and is related to hyperactive reflexes after upper motor neuron lesions. The hemiplegia table, which develops after subsiding, brings many problems along with it. Spasticity is one of these problems. Spasticity frequently leads to difficulty in the activities of daily life. It delays functional recovery, causes pain, and leads to secondary complications.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 21, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Being between the ages of 18-60

• To accept voluntary participation in the study

• Spastic Hemiplegia (Modified Ashworth Scale 2 and above)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hemiplegia
• Spastic Hemiplegia
• Stroke Sequelae

Intervention

Diagnostic Test:
• Nociceptor flexor reflex
The nociceptive flexion reflex (NFR) is a physiological, polysynaptic reflex allowing for painful stimuli to activate an appropriate withdrawal response

Drug:
• Botox
botox
• Baclofen
baclofen

Locations

Country	Name	City	State
Turkey	Hatay Mustafa Kemal University	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Visual 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
Primary	Range of motion	Range of motion (ROM) is the measurement of the amount of movement around a specific joint or body part	6 weeks
Primary	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