Neuropathic PainNCT05165901
Clinical Effect of LG Medipain for Managing Chronic Pain Disorders
A study testing Scrambler Therapy in people with Neuropathic Pain and Pain, run by Jeeyoun Moon at 1 site in South Korea.
Trial summary
Scrambler Therapy is a type of non-invasive neuromodulation. According to the researches that studied the effects of the existing Scrambler therapy, 10 times of Scrambler Therapy showed a significant pain relief lasting for more than 1-3 months in various pain disorders such as post-herpetic neuralgia, cancer-related… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Neuropathic Pain, Pain, Refractory Pain
- What is being tested?
- Scrambler Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2022to 15 Jan 2025
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain disease (pain over 3 months) as an adult 19 years of age or older
- Patients with 11-pointed NRS pain score ≥ 4 for the corresponding pain on the day of admission
- Patients taking oral pain treatment drugs in the same type and dose up to 1 month before participating in the study, and taking the same medication until 1 month after participating in the study (at the time of obtaining the primary endpoint)
- Those who voluntarily and in writing consent to participate in the study
- A person who has agreed in writing to return the Scrambler Therapy device
- By the classification of pain disorder, patients include with nociceptive pain such as joint pain, myofascial pain syndrome and with neuropathic pain such as postherpetic neuralgia, peripheral nerve injury and nerve entrapment syndrome and with mixed pain.
Who cannot join
- Refusal of the patient
- In case pain relief effect was not obtained in the past Scrambler Therapy
- Patients currently undergoing Scrambler therapy for pain control at outpatient clinics at the Pain Center
- Patients who had previously taken Scrambler Therapy 6 months before participating in the study
- In case of systemic infection or local infection in the area around the treatment (the patch attachment site)
- Patients who has cognitive decline that cannot understand the contents of the Numeric Pain Rating (NRS), questionnaire, and scrambler self application method
Show all 10Show fewer
- If it is difficult to self-administer 10 scrambler treatments for 2 weeks during the treatment period
- Women during pregnancy
- In case of implantation of a pacemaker, brain stimulator, etc.
- Those who are not suitable for this clinical trial under the judgment of other investigators
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Jee Y Moon, PhD, +82 2 2072 2462, jymoon0901@gmail.com
Jee Y Moon, PhD
About this study
Official title: Clinical Effect of LG Medipain for Managing Chronic Pain Disorders: A Prospective Observational Study
Scrambler Therapy is a type of non-invasive neuromodulation. According to the researches that studied the effects of the existing Scrambler therapy, 10 times of Scrambler Therapy showed a significant pain relief lasting for more than 1-3 months in various pain disorders such as post-herpetic neuralgia, cancer-related neuropathic pain, and mixed pain. No treatment-related side effects have been reported in Scrambler therapy conducted in previous studies.
The most inconvenient thing about Scrambler Therapy is that it has to be treated more than 10 times during specific period, so frequent visits to the hospital for treatment linked to the higher burden for the patient's cost and even those are not fully covered by the government's insurance. To reduce this discomfort and expand the range of treatment in the era of Corona of untact treatment, LG Electronics devised a home self-scrambler treatment device for pain patients.
Read more
The LG Medipain device has the same treatment function as the existing hospital Scrambler treatment device, but there has been no study on its efficacy and safety. Therefore, the investigators want to conduct this research and find out about the safety and equal efficiency of the LG Medipain Therapy.
In this study, it is expected that pain relief and improvement of quality of life can be obtained for patients with various types of chronic pain through self-application of LG Medipain device.
Read the detailed description
Scrambler Therapy is a type of non-invasive neuromodulation. Scrambler Therapy is a different type of pain treatment from the theory that converts pain signals into general sensory information (non-pain signals) generated in the human body through artificial neurons and transmits them to the CNS through A-delta and C-nerve fibers, which are pain-transmitting nerve fibers. The non-pain signal converted through Scrambler Therapy exhibits a pain modulatory effect through CNS education, and eventually, the pain signal is continuously disturbed into a pain-free signal, resulting in pain relief. This will function to normalize neuronal plasticity, the cause of chronic pain, which is different from existing pain treatments based on the gate control theory that temporarily blocks or alleviates the recognition of pain stimuli in the CNS.
Scrambler therapy is similar to the existing TENS treatment, but the treatment process is very different from TENS. TENS is a principle that replaces the delivery of pain stimulus to the brain with a stimulus other than pain stimulus and transmits it to the brain. However, Scrambler Therapy is a treatment that reduces the perception of pain in the brain by scrambling the conversion of pain stimulation into electrical signals in the peripheral nerves, similar to TENS, but can convert pain signals into pain-free signals through repetitive brain learning. So to speak, the investigators could state that it is a treatment method that fundamentally suppresses the generation of pain signals.
According to the researches that studied the effects of the existing Scrambler therapy, 10 times of Scrambler Therapy showed a significant pain relief lasting for more than 1-3 months in various pain disorders such as post-herpetic neuralgia, cancer-related neuropathic pain, and mixed pain. No treatment-related side effects have been reported in Scrambler therapy conducted in previous studies.
The most inconvenient thing about Scrambler Therapy is that it has to be treated more than 10 times during specific period, so frequent visits to the hospital for treatment linked to the higher burden for the patient's cost and even those are not fully covered by the government's insurance. To reduce this discomfort and expand the range of treatment in the era of Corona of untact treatment, LG Electronics devised a home self-scrambler treatment device, LG Medipain for pain patients.
While the hospital Scrambler Therapy device uses up to 5 channels (with 10 patches attached) for treatment and the size of the machine is large, the LG Medipain device uses 2 channels (up to 4 patches attached) and is portable and easy to use which is designed to be convenient. The LG Medipain device has the same treatment function as the existing hospital Scrambler treatment device, but there has been no study on its efficacy and safety. Therefore, the investigators want to conduct this research and find out about the safety and equal efficiency of the LG Medipain Therapy. In addition, in order to explore the mechanism of LG Medipain treatment, 30 patients who responded to treatment will be selected and the investigators have plan to examine their EEG waveform of 32 channel with their consents.
After 2 weeks of applying the LG Medipain Therapy for various chronic pain diseases, meaningful (MCD 30% for each group) pain relief effect will be obtained. The purpose of this study is to check whether pain relief can be obtained after 2 weeks of applying 10 times of the LG Medipain therapy for various chronic pain diseases. The secondary purpose of this study is to compare the pain and related-function improvement effects of the LG Medipain Therapy by pain classification. Scrambler treatment has been reported to have a pain relief effect on postherpetic neuralgia, various cancer pains, and musculoskeletal pain through basic 10 applications. In this study, it is expected that pain relief and improvement of quality of life can be obtained for patients with various types of chronic pain through self-application of the LG Medipain device.
- Conditions
- Neuropathic Pain, Pain, Refractory Pain, Chronic Pain
- Being tested
- Scrambler Therapy
- Medical subject headings
- Neuralgia, Pain, Pain, Intractable, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scrambler TherapyDevice
LG Medipain is a type of non-invasive neuromodulation.
| Study group | Role | What they receive |
|---|---|---|
| Nociceptive pain | Experimental | patients with joint pain (knee and shoulder), myofascial pain syndrome Receives: Device: Scrambler Therapy |
| Neuropathic pain | Experimental | patients with postherpetic neuralgia, peripheral nerve injury (CRPS type II, brachial plexopathy, nerve entrapment syndrome) Receives: Device: Scrambler Therapy |
| Mixed pain | Experimental | patients with spine or SIJ origin back and buttock pain or neck pain and SPINE-origin back pain과 neck pain, SIJ-origin back and buttock pain Receives: Device: Scrambler Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief scoreobtained after 2 weeks of applying
Pain relief by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)
Measured: after 2 weeks of applying
Secondary outcomes (6)
The painDETECT questionnaire (PD-Q)
The painDETECT questionnaire (PD-Q) for neuropathic pain score assessment
Measured: during 1 year of treatment
EuroQol-5 dimention(EQ-5D)
EuroQol-5 dimention(EQ-5D) for describing and valuing the health of life
Measured: during 1 year of treatment
patient global impression of change (PGIC)
patient global impression of change (PGIC) in self-report 5 scale reflects a patient's belief about the efficacy of treatment
Measured: during 1 year of treatment
Insomnia Severity Index
Insomnia Severity Index for assessing sleep difficulty
Measured: during 1 year of treatment
Oswestry Disability Index(ODI)
Oswestry Disability Index(ODI) for back \& neck functional disability
Measured: during 1 year of treatment
The Western Ontario and McMaster Universities(WOMAC) Index
The Western Ontario and McMaster Universities(WOMAC) Index to evaluate the patient's Hip and Knee Osteoarthritis.
Measured: during 1 year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start3 Jan 2022
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 different chronic pain classification
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeeyoun Moon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeeyoun Moon, Seoul National University
- Investigators
- Jee Yoon Moon, Pf, Study director, Seoul national universitiy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165901
- Sponsor's protocol ID
- 2110-017-1260
- Status last verified
- May 2024
- First submitted
- 1 Nov 2021
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of LG Medipain for Managing Chronic Pain Disorders: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05165901
- Acronym / sponsor ID
- 2110-017-1260
- Conditions
- Neuropathic Pain, Pain, Refractory Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jeeyoun MoonUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 21 Dec 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.
Scrambler Therapy is a type of non-invasive neuromodulation. According to the researches that studied the effects of the existing Scrambler therapy, 10 times of Scrambler Therapy showed a significant pain relief lasting for more than 1-3 months in various pain disorders such as post-herpetic neuralgia, cancer-related neuropathic pain, and mixed pain. No treatment-related side effects have been reported in Scrambler therapy conducted in previous studies.
The most inconvenient thing about Scrambler Therapy is that it has to be treated more than 10 times during specific period, so frequent visits to the hospital for treatment linked to the higher burden for the patient's cost and even those are not fully covered by the government's insurance. To reduce this discomfort and expand the range of treatment in the era of Corona of untact treatment, LG Electronics devised a home self-scrambler treatment device for pain patients.
The LG Medipain device has the same treatment function as the existing hospital Scrambler treatment device, but there has been no study on its efficacy and safety. Therefore, the investigators want to conduct this research and find out about the safety and equal efficiency of the LG Medipain Therapy.
In this study, it is expected that pain relief and improvement of quality of life can be obtained for patients with various types of chronic pain through self-application of LG Medipain device.
Detailed description
Scrambler Therapy is a type of non-invasive neuromodulation. Scrambler Therapy is a different type of pain treatment from the theory that converts pain signals into general sensory information (non-pain signals) generated in the human body through artificial neurons and transmits them to the CNS through A-delta and C-nerve fibers, which are pain-transmitting nerve fibers. The non-pain signal converted through Scrambler Therapy exhibits a pain modulatory effect through CNS education, and eventually, the pain signal is continuously disturbed into a pain-free signal, resulting in pain relief. This will function to normalize neuronal plasticity, the cause of chronic pain, which is different from existing pain treatments based on the gate control theory that temporarily blocks or alleviates the recognition of pain stimuli in the CNS.
Scrambler therapy is similar to the existing TENS treatment, but the treatment process is very different from TENS. TENS is a principle that replaces the delivery of pain stimulus to the brain with a stimulus other than pain stimulus and transmits it to the brain. However, Scrambler Therapy is a treatment that reduces the perception of pain in the brain by scrambling the conversion of pain stimulation into electrical signals in the peripheral nerves, similar to TENS, but can convert pain signals into pain-free signals through repetitive brain learning. So to speak, the investigators could state that it is a treatment method that fundamentally suppresses the generation of pain signals.
According to the researches that studied the effects of the existing Scrambler therapy, 10 times of Scrambler Therapy showed a significant pain relief lasting for more than 1-3 months in various pain disorders such as post-herpetic neuralgia, cancer-related neuropathic pain, and mixed pain. No treatment-related side effects have been reported in Scrambler therapy conducted in previous studies.
The most inconvenient thing about Scrambler Therapy is that it has to be treated more than 10 times during specific period, so frequent visits to the hospital for treatment linked to the higher burden for the patient's cost and even those are not fully covered by the government's insurance. To reduce this discomfort and expand the range of treatment in the era of Corona of untact treatment, LG Electronics devised a home self-scrambler treatment device, LG Medipain for pain patients.
While the hospital Scrambler Therapy device uses up to 5 channels (with 10 patches attached) for treatment and the size of the machine is large, the LG Medipain device uses 2 channels (up to 4 patches attached) and is portable and easy to use which is designed to be convenient. The LG Medipain device has the same treatment function as the existing hospital Scrambler treatment device, but there has been no study on its efficacy and safety. Therefore, the investigators want to conduct this research and find out about the safety and equal efficiency of the LG Medipain Therapy. In addition, in order to explore the mechanism of LG Medipain treatment, 30 patients who responded to treatment will be selected and the investigators have plan to examine their EEG waveform of 32 channel with their consents.
After 2 weeks of applying the LG Medipain Therapy for various chronic pain diseases, meaningful (MCD 30% for each group) pain relief effect will be obtained. The purpose of this study is to check whether pain relief can be obtained after 2 weeks of applying 10 times of the LG Medipain therapy for various chronic pain diseases. The secondary purpose of this study is to compare the pain and related-function improvement effects of the LG Medipain Therapy by pain classification. Scrambler treatment has been reported to have a pain relief effect on postherpetic neuralgia, various cancer pains, and musculoskeletal pain through basic 10 applications. In this study, it is expected that pain relief and improvement of quality of life can be obtained for patients with various types of chronic pain through self-application of the LG Medipain device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 different chronic pain classification
| Arm | Type | Receives |
|---|---|---|
| Nociceptive pain | Experimental | Device: Scrambler Therapypatients with joint pain (knee and shoulder), myofascial pain syndrome |
| Neuropathic pain | Experimental | Device: Scrambler Therapypatients with postherpetic neuralgia, peripheral nerve injury (CRPS type II, brachial plexopathy, nerve entrapment syndrome) |
| Mixed pain | Experimental | Device: Scrambler Therapypatients with spine or SIJ origin back and buttock pain or neck pain and SPINE-origin back pain과 neck pain, SIJ-origin back and buttock pain |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic pain disease (pain over 3 months) as an adult 19 years of age or older
- Patients with 11-pointed NRS pain score ≥ 4 for the corresponding pain on the day of admission
- Patients taking oral pain treatment drugs in the same type and dose up to 1 month before participating in the study, and taking the same medication until 1 month after participating in the study (at the time of obtaining the primary endpoint)
- Those who voluntarily and in writing consent to participate in the study
- A person who has agreed in writing to return the Scrambler Therapy device
Key exclusion criteria (10 listed)
- Refusal of the patient
- In case pain relief effect was not obtained in the past Scrambler Therapy
- Patients currently undergoing Scrambler therapy for pain control at outpatient clinics at the Pain Center
- Patients who had previously taken Scrambler Therapy 6 months before participating in the study
- In case of systemic infection or local infection in the area around the treatment (the patch attachment site)
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 |
|---|---|---|
| Scrambler TherapyLG Medipain is a type of non-invasive neuromodulation. | Device | Mixed pain, Neuropathic pain, Nociceptive pain |
Primary outcome
Pain relief scoreobtained after 2 weeks of applying
Time frame: after 2 weeks of applying
Pain relief by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)
6 secondary outcomes
The painDETECT questionnaire (PD-Q)
Time frame: during 1 year of treatment
EuroQol-5 dimention(EQ-5D)
Time frame: during 1 year of treatment
patient global impression of change (PGIC)
Time frame: during 1 year of treatment
Insomnia Severity Index
Time frame: during 1 year of treatment
Oswestry Disability Index(ODI)
Time frame: during 1 year of treatment
The Western Ontario and McMaster Universities(WOMAC) Index
Time frame: during 1 year of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
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.
Jee Yoon Moon, Pf study director
Seoul national universitiy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scrambler Therapy in people with Neuropathic Pain and Pain, run by Jeeyoun Moon at 1 site in South Korea.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 May 2024. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jee Yoon Moon, Pf (+82 2 2072 2462, jymoon0901@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief scoreobtained after 2 weeks of applying (time frame: after 2 weeks of applying). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2024.