Multiple SclerosisNCT06153264
Neural Mobilization on Multiple Sclerosis
A study testing neurodynamic mobilization exercise and strengthening exercises in people with Multiple Sclerosis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- neurodynamic mobilization exercise and strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with MS according to McDonald 2010 diagnostic criteria
- Being between the ages of 18-65
- Volunteering to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- neurodynamic mobilization exercise, strengthening exercises
- Keywords
- Multiple Sclerosis, Strength, Neuro mobilization, pain
- Medical subject headings
- Multiple Sclerosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurodynamic mobilization exerciseOther
Upper extremity neurodynamic mobilization exercises and upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks.
strengthening exercisesOther
upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks. Receives: Other: strengthening exercises |
| Study Group | Experimental | Upper extremity neurodynamic mobilization exercises and upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks. Receives: Other: neurodynamic mobilization exercise; Other: strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
It is a scale used to determine the severity of pain and to clinically monitor pain.0 worst score/10 best score
Measured: Baseline and after 6 weeks
Leeds Assessment of Neuropathic Symptoms and Signs Scale
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.
Measured: Baseline and after 6 weeks
Secondary outcomes (3)
Muscle strength
Upper extremity muscles will be evaluated using a digital dynamometer (Knect).
Measured: Baseline and after 6 weeks
Manual Ability Measure-36
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
Measured: Baseline and after 6 weeks
Nine hole peg test
It is a validated test in MS where manual dexterity is measured in seconds based on performance. A lower time is better score.
Measured: Baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start15 Sep 2023
- Primary completion15 Jun 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekiye İpek KATIRCI KIRMACI, Kahramanmaras Sutcu Imam University
- Investigators
- Zekiye İpek Katırcı Kırmacı, Principal investigator, Kahramanmaras Sütçü İmam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153264
- Sponsor's protocol ID
- ipek.kirmaci
- Status last verified
- Aug 2024
- First submitted
- 22 Nov 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurodynamic Mobilization Exercises on Pain, Muscle Strength and Manual Dexterity in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT06153264
- Acronym / sponsor ID
- ipek.kirmaci
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Strength, Neuro mobilization, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: strengthening exercisesUpper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks. |
| Study Group | Experimental | Other: neurodynamic mobilization exercise, Other: strengthening exercisesUpper extremity neurodynamic mobilization exercises and upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being diagnosed with MS according to McDonald 2010 diagnostic criteria
- Being between the ages of 18-65
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurodynamic mobilization exerciseUpper extremity neurodynamic mobilization exercises and upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks. | Other | Study Group |
| strengthening exercisesupper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks | Other | Control Group, Study Group |
Primary outcome
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
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.
3 secondary outcomes
Muscle strength
Time frame: Baseline and after 6 weeks
Manual Ability Measure-36
Time frame: Baseline and after 6 weeks
Nine hole peg test
Time frame: Baseline and after 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zekiye İpek Katırcı Kırmacı principal investigator
Kahramanmaras Sütçü İmam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurodynamic mobilization exercise and strengthening exercises in people with Multiple Sclerosis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Baseline and after 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024; AzTrials last refreshed its copy on 28 Oct 2026.