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NCT Number: NCT05110586

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaraş Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electrotherapy

Other

Applications will be applied for 4 weeks, 5 days a week

Primary outcomes

  1. The Visual Analog Scale (VAS)

    Time frame: Change from Baseline at 4 weeks

    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.

  2. Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain questionnaire

    Time frame: Change from Baseline at 4 weeks

    The scale is scored between 0-24 points and above 12 points suggests neuropathic pain.

Secondary outcomes

  1. 2 min walk test

    Time frame: Change from Baseline at 4 weeks

    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.

  2. Multiple Sclerosis International Quality of Life Questionnaire

    Time frame: Change from Baseline at 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

The Effect of Different Electrical Stimulations on Pain, Functional Capacity and Quality of Life in Multiple Sclerosis Patients

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2021
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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