Clinical Effect of LG Medipain for Managing Chronic Pain Disorders

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Chronic Pain; Neuropathic Pain; Refractory Pain
• Intervention / Treatment: Device: Scrambler Therapy

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jee Yoon Moon, Pf; Phone Number: +82 2 2072 2462; Email: jymoon0901@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital
    • Contact: Jee Y Moon, PhD; Phone Number: +82 2 2072 2462; Email: jymoon0901@gmail.com
    • Principal Investigator: Jee Y Moon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nociceptive pain; patients with joint pain (knee and shoulder), myofascial pain syndrome	Device: Scrambler Therapy; LG Medipain is a type of non-invasive neuromodulation.
Experimental: Neuropathic pain; patients with postherpetic neuralgia, peripheral nerve injury (CRPS type II, brachial plexopathy, nerve entrapment syndrome)	Device: Scrambler Therapy; LG Medipain is a type of non-invasive neuromodulation.
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; LG Medipain is a type of non-invasive neuromodulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief scoreobtained after 2 weeks of applying	Pain relief by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)	after 2 weeks of applying

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The painDETECT questionnaire (PD-Q)	The painDETECT questionnaire (PD-Q) for neuropathic pain score assessment	during 1 year of treatment
EuroQol-5 dimention(EQ-5D)	EuroQol-5 dimention(EQ-5D) for describing and valuing the health of life	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	during 1 year of treatment
Insomnia Severity Index	Insomnia Severity Index for assessing sleep difficulty	during 1 year of treatment
Oswestry Disability Index(ODI)	Oswestry Disability Index(ODI) for back & neck functional disability	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.	during 1 year of treatment

Collaborators and Investigators

• Sponsor: Jeeyoun Moon
• Investigators: Study Director: Jee Yoon Moon, Pf, Seoul national universitiy Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Estimated): January 15, 2025
• Study Completion (Estimated): January 15, 2025

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Neuralgia; Somatoform Disorders; Pain, Intractable
• Other Study ID Numbers: 2110-017-1260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No