Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07482618

Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection

Tolperison is an antispastic agent used in the treatment of spasticity. Studies on tolperison are limited, and the literature on its effectiveness against spasticity and neuropathic pain is also limited.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Spastic Hemiplegia Hemiplegia Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 month–80 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Kayseri City Hospital Physical Medicine and Rehabilitation

Kayseri, Kocasinan, Turkey (Türkiye)

About this study

Botulinum toxin injection is the most commonly used antispastic agent in the treatment of regional spasticity in hemiplegia patients. Both botulinum toxin injections and oral antispastic agents are widely used. Many studies have shown that botulinum toxin injection is more effective in treating regional spasticity. Because botulinum toxin injection is more frequently preferred, the study included patients who received botulinum toxin injections. Patients receiving botulinum toxin injections benefit from the injection, but in some patients, the injection is insufficient. Additionally, oral antispastic agents such as baclofen, tizanidine, and tolperisone are also added to the treatment. Reimbursement for tolperisone for hemiplegia patients has recently begun. It is covered by the Social Security Institution (SGK), but it is not a widely used drug. The researcher will screen patients diagnosed with hemiplegia who have been initiated with daily botulinum toxin injections (+/- tolperison). Patients will be followed prospectively. Patients prescribed tolperison will be examined before receiving the medication, and post-treatment follow-ups will be evaluated using questionnaires. The aim was to observe whether tolperison makes a difference between the groups. Patients in the botulinum toxin injection group will be followed before and after the injection. The aim of this study is to examine the effectiveness of tolperison in antispasticity and neuropathic pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to stand
  • History of previous hemorrhagic or ischemic stroke
  • Stroke-related spasticity (MAS ≥2)
  • Men and women aged 18-80 years
  • Agreement to participate in the study

Exclusion criteria

  • Diabetes patients
  • people who have undergone orthopedic surgery
  • Individuals with non-stroke neurological diseases
  • Those receiving oral antispastic treatment (non-tolperison medications)
  • Those who have undergone surgery for spasticity
  • Individuals lacking orientation and cooperation
  • Those undergoing surgery, such as with intrathecal baclofen
  • Individuals receiving medical treatment for neuropathic pain
  • Individuals under 18 and over 80 years of age
  • History of allergy or hypersensitivity to the medication to be used
  • Presence of a fixed contracture in the affected extremity

Treatment and study plan

Primary outcomes

  1. Modified Ashworth Scale(MAS)

    Time frame: Time Frame: Baseline (Day O), Day 15, Month 1, and Month 3.

    Spasticity severity will be assessed using the Modified Ashworth Scale (MAS). The MAS evaluates resistance during passive soft-tissue stretching and is graded on a 6-point scale (0, 1, 1+, 2, 3, 4). Higher scores indicate greater spasticity. Measurements will be recorded before botulinum toxin injection and during follow-up visits.

  2. Douleur Neuropathique 4 (DN4)

    Time frame: Time Frame: Baseline (Day O), Day 15, Month 1, and Month 3.

    Neuropathic pain will be evaluated using the Douleur Neuropathique 4 (DN4) questionnaire.The DN4 consists of 10 items assessing neuropathic pain symptoms and sensory examination findings. Each item is scored as 0 (no) or 1 (yes). A total score ≥4 indicates neuropathic pain.

Secondary outcomes

  1. Walking Speed Assessed by the 10-Meter Walk Test (10MWT)

    Time frame: Time Frame: Baseline (Day 0), Day 15, Month 1, and Month 3.

    Walking ability will be evaluated using the 10-Meter Walk Test. Participants will be asked to walk a distance of 10 meters at their comfortable walking speed. Walking speed will be calculated in meters per second.

Sponsors and collaborators

Lead sponsor

Ayse Guc

Other Gov

Collaborators

  • Kayseri City Hospital

Registry information

Official study title

Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection: A Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.