Neural Mobilization on Multiple Sclerosis

August 20, 2024 updated by: Zekiye İpek KATIRCI KIRMACI, Kahramanmaras Sutcu Imam University

Effect of Neurodynamic Mobilization Exercises on Pain, Muscle Strength and Manual Dexterity in Multiple Sclerosis Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Kahramanmaraş, Turkey
        • Kahramanmaras Sutcu Imam University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Being diagnosed with MS according to McDonald 2010 diagnostic criteria
  2. Being between the ages of 18-65
  3. Volunteering to participate in the study

Exclusion Criteria:

  1. Being under 18 years of age and over 65 years of age
  2. Having a history of trauma within the last year
  3. Having alcohol and substance addiction
  4. Having diabetes mellitus
  5. Having another known neurological disease
  6. Being pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control Group
Upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks.
Other: strengthening exercises
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.
Other: strengthening exercises
upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks
Other: neurodynamic mobilization exercise
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
Baseline and after 6 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zekiye İpek Katırcı Kırmacı, Kahramanmaras Sutcu Imam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ipek.kirmaci

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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