Clinical trial NCT03860662: The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex
Official title: Doctor, Physical Medicine and Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke Sequelae
Spastic Hemiplegia
Keywords: Antispastic drugs
Nociceptive flexor reflex
Baclofen
Botulinum toxin
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: thershold of nociceptive flexor reflex
timeFrame: 6 weeks
measure: Barthel index
timeFrame: 6 weeks
measure: Vısual analog scale
timeFrame: 6 weeks
measure: Range of motion
timeFrame: 6 weeks
measure: Modified Ashworth scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University
Study officials:
References: