Multiple SclerosisNCT05110586
Electrical Stimulations on Pain, Functional Capacity and Quality of Life in Multiple Sclerosis
A study testing Electrotherapy in people with Multiple Sclerosis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Electrotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with MS according to McDonald 2010 diagnostic criteria
- 18-65 years old
- Volunteering to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sutcu Imam University
Kahramanmaraş
About this study
Official title: The Effect of Different Electrical Stimulations on Pain, Functional Capacity and Quality of Life in Multiple Sclerosis Patients
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.
Read the 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
- Being tested
- Electrotherapy
- Keywords
- pain, functional capacity, Quality of life, electrotherapy
- Medical subject headings
- Multiple Sclerosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrotherapyOther
Applications will be applied for 4 weeks, 5 days a week
| Study group | Role | What they receive |
|---|---|---|
| 1st group: TENS | Experimental | Tens will be applied. Receives: Other: Electrotherapy |
| 2nd group: Interferential current | Experimental | Interferential current will be applied. Receives: Other: Electrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline at 4 weeks
Secondary outcomes (2)
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.
Measured: Change from Baseline at 4 weeks
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.
Measured: Change from Baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 May 2022
- Primary completion15 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekiye İpek KATIRCI KIRMACI, Kahramanmaras Sutcu Imam University
- Investigators
- Zekiye İpek Katırcı Kırmacı, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110586
- Sponsor's protocol ID
- ipekkirmaci
- Status last verified
- Nov 2022
- First submitted
- 14 Oct 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36738692
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Electrical Stimulations on Pain, Functional Capacity and Quality of Life in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05110586
- Acronym / sponsor ID
- ipekkirmaci
- Conditions
- Multiple Sclerosis
- Keywords
- pain, functional capacity, Quality of life, electrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st group: TENS | Experimental | Other: ElectrotherapyTens will be applied. |
| 2nd group: Interferential current | Experimental | Other: ElectrotherapyInterferential current will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having been diagnosed with MS according to McDonald 2010 diagnostic criteria
- 18-65 years old
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrotherapyApplications will be applied for 4 weeks, 5 days a week | Other | 1st group: TENS, 2nd group: Interferential current |
Primary outcome
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.
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.
2 secondary outcomes
2 min walk test
Time frame: Change from Baseline at 4 weeks
Multiple Sclerosis International Quality of Life Questionnaire
Time frame: Change from Baseline at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 36738692Katirci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zekiye İpek Katırcı Kırmacı principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrotherapy in people with Multiple Sclerosis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analog Scale (VAS) (time frame: Change from Baseline at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05110586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.