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RecruitingNCT05165901Updated May 29, 2024

Clinical Effect of LG Medipain for Managing Chronic Pain Disorders

An interventional study of Scrambler Therapy in Neuropathic Pain, Pain and Refractory Pain, sponsored by Jeeyoun Moon. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.

Sponsored by Jeeyoun Moon · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study 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 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.

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.

02

Conditions studied

  • Neuropathic Pain
  • Pain
  • Refractory Pain
  • Chronic Pain
03

In context

Neuralgia

1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.

This study's planned enrollment of 90 is above the median of 52 across 831 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Jeeyoun Moon is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Nociceptive pain

    patients with joint pain (knee and shoulder), myofascial pain syndrome

    Device: Scrambler Therapy

  • Experimental
    Neuropathic pain

    patients with postherpetic neuralgia, peripheral nerve injury (CRPS type II, brachial plexopathy, nerve entrapment syndrome)

    Device: Scrambler Therapy

  • Experimental
    Mixed pain

    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

    Device: Scrambler Therapy

Interventions

  • DeviceScrambler Therapy

    LG Medipain is a type of non-invasive neuromodulation.

06

What researchers measure

Primary outcomes

  1. Pain relief scoreobtained after 2 weeks of applying

    Pain relief by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)

    Time frame: after 2 weeks of applying

Secondary outcomes

  1. The painDETECT questionnaire (PD-Q)

    The painDETECT questionnaire (PD-Q) for neuropathic pain score assessment

    Time frame: during 1 year of treatment

  2. EuroQol-5 dimention(EQ-5D)

    EuroQol-5 dimention(EQ-5D) for describing and valuing the health of life

    Time frame: during 1 year of treatment

  3. 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

    Time frame: during 1 year of treatment

  4. Insomnia Severity Index

    Insomnia Severity Index for assessing sleep difficulty

    Time frame: during 1 year of treatment

  5. Oswestry Disability Index(ODI)

    Oswestry Disability Index(ODI) for back \& neck functional disability

    Time frame: during 1 year of treatment

  6. 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.

    Time frame: during 1 year of treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05165901
Lead sponsor
Jeeyoun Moon
Responsible party
Jeeyoun Moon (Chief director, pain management center, Seoul National University Hospital, Seoul National University) — Sponsor-investigator
First posted
Dec 21, 2021
Start date
Jan 3, 2022
Primary completion
Jan 15, 2025 (estimated)
Completion
Jan 15, 2025 (estimated)
Last update
May 29, 2024

Study contacts

Jee Yoon Moon, Pf
Contact
jymoon0901@gmail.com
+82 2 2072 2462
Jee Yoon Moon, Pf
study director · Seoul national universitiy Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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