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

NCT ID: NCT05110586

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-08-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1st group: TENS

Tens will be applied.

Group Type: EXPERIMENTAL

Electrotherapy

Intervention Type: OTHER

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

2nd group: Interferential current

Interferential current will be applied.

Group Type: EXPERIMENTAL

Electrotherapy

Intervention Type: OTHER

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

Interventions

Electrotherapy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Zekiye İpek KATIRCI KIRMACI

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zekiye İpek Katırcı Kırmacı

Role: PRINCIPAL_INVESTIGATOR

Kahramanmaras Sutcu Imam University

Locations

Kahramanmaraş Sutcu Imam University

Kahramanmaraş, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Katirci Kirmaci ZI, Adiguzel H, Gogremis M, Kirmaci YS, Inanc Y, Tuncel Berktas D. The effect of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) on pain, functional capacity, and quality of life in patients with multiple sclerosis: A randomized controlled, single-blinded study. Mult Scler Relat Disord. 2023 Mar;71:104541. doi: 10.1016/j.msard.2023.104541. Epub 2023 Jan 29.

Reference Type: DERIVED

PMID: 36738692 (View on PubMed)

Other Identifiers

ipekkirmaci

Identifier Type: -

Identifier Source: org_study_id