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

NCT05110586 | Completed

• 1 other identifier: ipekkirmaci
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

pain; functional capacity; Quality of life; electrotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from Baseline at 4 weeks

• 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.

  Change from Baseline at 4 weeks

Secondary Outcomes (2)

• 2 min walk test

  Change from Baseline at 4 weeks

• Multiple Sclerosis International Quality of Life Questionnaire

  Change from Baseline at 4 weeks

Study Arms (2)

1st group: TENS

EXPERIMENTAL

Tens will be applied.

Other: Electrotherapy

2nd group: Interferential current

EXPERIMENTAL

Interferential current will be applied.

Other: Electrotherapy

Interventions

Electrotherapy OTHER

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

1st group: TENS; 2nd group: Interferential current

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36738692 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Pain

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Zekiye İpek Katırcı Kırmacı

  Kahramanmaras Sutcu Imam 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: October 14, 2021
• First Posted: November 8, 2021
• Study Start: May 1, 2022
• Primary Completion: August 15, 2022
• Study Completion: August 30, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)