NCT06153264

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

November 22, 2023

Last Update Submit

August 20, 2024

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisStrengthNeuro mobilizationpain

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Baseline and after 6 weeks

Secondary Outcomes (3)

  • Muscle strength

    Baseline and after 6 weeks

  • Manual Ability Measure-36

    Baseline and after 6 weeks

  • Nine hole peg test

    Baseline and after 6 weeks

Study Arms (2)

Control Group

EXPERIMENTAL

Upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks.

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.

Other: neurodynamic mobilization exerciseOther: strengthening exercises

Interventions

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.

Study Group
strengthening exercisesOTHER

upper extremity strengthening exercises will be applied 10 repetitions a day, 3 days a week for 6 weeks

Control GroupStudy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisPain

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zekiye İpek Katırcı Kırmacı

    Kahramanmaras Sütçü İmam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof

Study Record Dates

First Submitted

November 22, 2023

First Posted

December 1, 2023

Study Start

September 15, 2023

Primary Completion

June 15, 2024

Study Completion

July 15, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)