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Electrical Stimulations on Pain, Functional Capacity and Quality of Life in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Electrotherapy
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring pain, functional capacity, Quality of life, electrotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having been diagnosed with MS according to McDonald 2010 diagnostic criteria
  • 18-65 years old
  • Volunteering to participate in the study

Exclusion Criteria:

  • Less than 18 years old, over 65 years old
  • Having a history of trauma in the last 1 year
  • Having alcohol and substance addiction
  • Having diabetes mellitus
  • Presence of other known neurological disease
  • Having a pregnancy

Sites / Locations

  • Kahramanmaraş Sutcu Imam University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1st group: TENS

2nd group: Interferential current

Arm Description

Tens will be applied.

Interferential current will be applied.

Outcomes

Primary Outcome Measures

The Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a scale used to determine the severity of pain. Two end definitions of the parameter to be evaluated are written on the two end points of a 100 mm line and the patient is asked to indicate where his/her condition is appropriate on this line.
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain questionnaire
The scale is scored between 0-24 points and above 12 points suggests neuropathic pain.

Secondary Outcome Measures

2 min walk test
Individuals are asked to walk as fast as possible in a 25 m corridor without running. The distance they walked for two minutes is recorded.
Multiple Sclerosis International Quality of Life Questionnaire
The questionnaire indicates quality of life. the index score are linearly transformed and standardized on a 0 to 100 scale, where 0 indicates the worst possible level of QoL and 100 indicates the best level.

Full Information

First Posted
October 14, 2021
Last Updated
November 14, 2022
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT05110586
Brief Title
Electrical Stimulations on Pain, Functional Capacity and Quality of Life in Multiple Sclerosis
Official Title
The Effect of Different Electrical Stimulations on Pain, Functional Capacity and Quality of Life in Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Multiple Sclerosis (MS) is a chronic neurological disease with local inflammation, gliosis and demyelination in the central nervous system (CNS). It is characterized by demyelinating plaques in the brain and spinal cord. Many different symptoms can be seen in the CNS, depending on the affected areas. One of the most common symptoms in these patients is pain. Approximately 50% of patients complain of pain at some point in their lives, and pain is one of the initial symptoms in 20%. 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 . In conclusion, pain in MS negatively affects the physical and emotional functions and quality of life of patients. In addition to pharmacological treatments, non-pharmacological interventions such as electrotherapy and exercise are present among the available treatments for pain in MS patients.
Detailed Description
In electrotherapy applications, Transcutaneous Electrical Nerve Stimulation (TENS) is defined as a method of applying high-frequency low-intensity electric current to the nervous system through superficial electrodes placed on the painful area or the nerve innervating that area, used all over the world in the treatment of pain, FDA approved in the United States. Its effectiveness is thought to be the result of a combination of effects such as stimulation of large-scale afferent fibers that inhibit the activity of primary afferent pain neurons or endogenous opioid-dependent mechanisms including the release of dynorphins, enkephalins and endorphins in the central nervous system . Interferential current are medium frequency currents. The analgesic effect of this current is based on the gate control theory. The disadvantage compared to TENS is that it provides lower neural adaptations with higher currents. As a result of this study, it is thought that the determination of effective treatment methods for pain, which is one of the common symptoms of MS patients, will increase the functional capacity and quality of life of the patient. In the study, patients who meet the inclusion criteria will be divided into 2 groups by randomization, TENS will be applied to the 1st group, and interference current will be applied to the 2nd group. Applications will be applied for 4 weeks, 5 days a week. Evaluations will be made by a blind physiotherapist twice, before and after the treatment. Assessments include sociodemographic information, pain, functional capacity, and quality of life. In addition to the studies in the literature, this study will be the first to compare the effectiveness of different electrical stimulations in pain in MS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
pain, functional capacity, Quality of life, electrotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1st group: TENS
Arm Type
Experimental
Arm Description
Tens will be applied.
Arm Title
2nd group: Interferential current
Arm Type
Experimental
Arm Description
Interferential current will be applied.
Intervention Type
Other
Intervention Name(s)
Electrotherapy
Intervention Description
Applications will be applied for 4 weeks, 5 days a week
Primary Outcome Measure Information:
Title
The Visual Analog Scale (VAS)
Description
The Visual Analog Scale (VAS) is a scale used to determine the severity of pain. Two end definitions of the parameter to be evaluated are written on the two end points of a 100 mm line and the patient is asked to indicate where his/her condition is appropriate on this line.
Time Frame
Change from Baseline at 4 weeks
Title
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain questionnaire
Description
The scale is scored between 0-24 points and above 12 points suggests neuropathic pain.
Time Frame
Change from Baseline at 4 weeks
Secondary Outcome Measure Information:
Title
2 min walk test
Description
Individuals are asked to walk as fast as possible in a 25 m corridor without running. The distance they walked for two minutes is recorded.
Time Frame
Change from Baseline at 4 weeks
Title
Multiple Sclerosis International Quality of Life Questionnaire
Description
The questionnaire indicates quality of life. the index score are linearly transformed and standardized on a 0 to 100 scale, where 0 indicates the worst possible level of QoL and 100 indicates the best level.
Time Frame
Change from Baseline at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having been diagnosed with MS according to McDonald 2010 diagnostic criteria 18-65 years old Volunteering to participate in the study Exclusion Criteria: Less than 18 years old, over 65 years old Having a history of trauma in the last 1 year Having alcohol and substance addiction Having diabetes mellitus Presence of other known neurological disease Having a pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zekiye İpek Katırcı Kırmacı
Organizational Affiliation
Kahramanmaraş Sütçü İmam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaraş Sutcu Imam University
City
Kahramanmaraş
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Electrical Stimulations on Pain, Functional Capacity and Quality of Life in Multiple Sclerosis

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