Clinical trial NCT05110586: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: pain
functional capacity
Quality of life
electrotherapy
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Visual Analog Scale (VAS)
timeFrame: Change from Baseline at 4 weeks
measure: Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain questionnaire
timeFrame: Change from Baseline at 4 weeks
Secondary outcomes:
measure: 2 min walk test
timeFrame: Change from Baseline at 4 weeks
measure: Multiple Sclerosis International Quality of Life Questionnaire
timeFrame: Change from Baseline at 4 weeks
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaraş Sutcu Imam University
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Zekiye İpek Katırcı Kırmacı
role: PRINCIPAL_INVESTIGATOR
References: