Clinical Effect of LG Medipain for Managing Chronic Pain Disorders (NCT05165901) | Clinical Trial Compass
UnknownNot Applicable
Clinical Effect of LG Medipain for Managing Chronic Pain Disorders
South Korea90 participantsStarted 2022-01-03
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 scr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain relief scoreobtained after 2 weeks of applying