Clinical Effect of LG Medipain for Managing Chronic Pain Disorders

NCT05165901 | Recruiting DMC

• 1 other identifier: 2110-017-1260
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain; Pain; Refractory Pain; Chronic Pain

Outcome Measures

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)

  after 2 weeks of applying

Secondary Outcomes (6)

• The painDETECT questionnaire (PD-Q)

  during 1 year of treatment

• EuroQol-5 dimention(EQ-5D)

  during 1 year of treatment

• patient global impression of change (PGIC)

  during 1 year of treatment

• Insomnia Severity Index

  during 1 year of treatment

• Oswestry Disability Index(ODI)

  during 1 year of treatment

Study Arms (3)

Nociceptive pain

EXPERIMENTAL

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

Device: Scrambler Therapy

Neuropathic pain

EXPERIMENTAL

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

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

Device: Scrambler Therapy

Interventions

Scrambler Therapy DEVICE

LG Medipain is a type of non-invasive neuromodulation.

Mixed pain; Neuropathic pain; Nociceptive pain

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeeyoun Moon: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Neuralgia; Pain; Pain, Intractable; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jee Yoon Moon, Pf

  Seoul national universitiy Hospital

  STUDY DIRECTOR

Central Study Contacts

Jee Yoon Moon, Pf

CONTACT

+82 2 2072 2462; jymoon0901@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief director, pain management center, Seoul National University Hospital

Model Details: 3 different chronic pain classification

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: December 21, 2021
• Study Start: January 3, 2022
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)