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

• ClinicalTrials.gov Identifier: NCT03860662
• Recruitment Status: Completed
• First Posted: March 4, 2019
• Last Update Posted: June 18, 2021
• Sponsor: Mustafa Kemal University
• Information provided by (Responsible Party): ERTURK GUNTURK, Mustafa Kemal University

Tracking Information

• First Submitted Date: February 8, 2019
• First Posted Date: March 4, 2019
• Last Update Posted Date: June 18, 2021
• Actual Study Start Date: May 26, 2018
• Actual Primary Completion Date: March 21, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 1, 2019)

• thershold of nociceptive flexor reflex [ Time Frame: 6 weeks ]
  The nociceptive flexion reflex (NFR) is a physiological, polysynaptic reflex allowing for painful stimuli to activate an appropriate withdrawal response
• Barthel index [ Time Frame: 6 weeks ]
  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 .
• Vısual analog scale [ Time Frame: 6 weeks ]
  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.
• Range of motion [ Time Frame: 6 weeks ]
  Range of motion (ROM) is the measurement of the amount of movement around a specific joint or body part
• Modified Ashworth scale [ Time Frame: 6 weeks ]
  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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex
• Official Title: Doctor, Physical Medicine and Rehabilitation
• 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

• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition

• Stroke Sequelae
• Spastic Hemiplegia

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
• Drug: Baclofen
  baclofen

Study Arms

• Active Comparator: 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.
  Interventions:

  • Diagnostic Test: Nociceptor flexor reflex
  • Drug: 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.
  Interventions:

  • Diagnostic Test: Nociceptor flexor reflex
  • Drug: Baclofen

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 13, 2021): 29
• Original Estimated Enrollment (submitted: March 1, 2019): 30
• Actual Study Completion Date: April 21, 2019
• Actual Primary Completion Date: March 21, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT03860662
• Other Study ID Numbers: MustafaKUPMR
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: ERTURK GUNTURK, Mustafa Kemal University
• Original Responsible Party: Same as current
• Current Study Sponsor: Mustafa Kemal University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Mustafa Kemal University
• Verification Date: June 2021