- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06153264
Neural Mobilization on Multiple Sclerosis
Effect of Neurodynamic Mobilization Exercises on Pain, Muscle Strength and Manual Dexterity in Multiple Sclerosis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Multiple Sclerosis (MS) is a chronic neurological disease characterized by local inflammation, gliosis and demyelination in the central nervous system (CNS). It is characterized by demyelinating plaques seen in the brain and medulla spinalis. Many different symptoms can be seen depending on the affected areas in the CNS. One of the common symptoms in these patients is pain. Approximately 50% of patients complain of pain at some point in their lives, and in 20% of them, pain is one of the initial symptoms. Pain may originate from the musculoskeletal system; It may also develop due to inflammation and upper motor neuron damage and may have a neuropathic character. As a result, pain in MS negatively affects patients' physical, emotional functions and quality of life.
Current treatments for pain in MS patients include the use of non-pharmacological interventions such as electrotherapy and exercise, as well as pharmacological treatments. Neurodynamic mobilization exercises are an intervention that aims to restore homeostasis in and around the nervous system by activating the nervous system itself or the structures surrounding the nervous system. Neurodynamic mobilization facilitates movement between neural structures and their environment through manual techniques and exercise. Human and animal studies reveal that neurodynamic mobilization reduces intraneural edema, improves intraneural fluid distribution, reduces thermal and mechanical hyperalgesia, and reverses increased immune responses following a nerve injury.
As a result of this study, it is thought that the determination of effective treatment methods for pain, which is a common symptom of MS patients, will increase the patient's muscle strength and dexterity.
The aim of the study is to examine the effects of neurodynamic mobilization exercises on pain, muscle strength and dexterity in Multiple Sclerosis patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kahramanmaraş, Turkey
- Kahramanmaraş Sütçü İmam University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being diagnosed with MS according to McDonald 2010 diagnostic criteria
- Being between the ages of 18-65
- Volunteering to participate in the study
Exclusion Criteria:
- Being under 18 years of age and over 65 years of age
- Having a history of trauma within the last year
- Having alcohol and substance addiction
- Having diabetes mellitus
- Having another known neurological disease
- Being pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
Upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks.
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upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks
|
|
Experimental: Study Group
Upper extremity neurodynamic mobilization exercises and upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks.
|
upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks
Upper extremity neurodynamic mobilization exercises and upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: Baseline and after 6 weeks
|
It is a scale used to determine the severity of pain and to clinically monitor pain.0 worst score/10 best score
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Baseline and after 6 weeks
|
|
Leeds Assessment of Neuropathic Symptoms and Signs Scale
Time Frame: Baseline and after 6 weeks
|
It is a multidimensional scale based on the analysis of short-term survey data that can be applied to the patient at the bedside and is especially used to differentiate between neuropathic and nociceptive pain.
The scale is scored between 0 and 24 points, and a A score higher than 12 points indicates neuropathic pain.
|
Baseline and after 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle strength
Time Frame: Baseline and after 6 weeks
|
Upper extremity muscles will be evaluated using a digital dynamometer (Knect).
|
Baseline and after 6 weeks
|
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Manual Ability Measure-36
Time Frame: Baseline and after 6 weeks
|
In this survey, in order to evaluate manual dexterity, it is questioned how difficult it is to perform 36 activities determined to represent daily living activities without the use of assistive devices.
Items are rated on a 4-point Likert-type scale from 0 (almost never performed) to 4 (easy).
Scores on the 36 items were summed to create a raw total score, and then the raw scores were converted to transformed manual ability measures, which range from 0 to 100
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Baseline and after 6 weeks
|
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Nine hole peg test
Time Frame: Baseline and after 6 weeks
|
It is a validated test in MS where manual dexterity is measured in seconds based on performance.
A lower time is better score.
|
Baseline and after 6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zekiye İpek Katırcı Kırmacı, Kahramanmaraş Sütçü İmam University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ipek.kirmaci
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
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