An exploratory study for NS-US100, a focused ultrasound stimulation system. A randomized single-blind clinical trial for safety and pain relief in patients with neuropathic pain.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0007894

Enrollment

Registered

2022-11-11

Start date

2020-08-31

Completion date

Unknown

Last updated

2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Clinical trial participants must satisfy both selection criteria and exclusion criteria. The participants who passed the criteria will be randomly assigned in to test group or control

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Adults between 19 years old and 75 years old 2)Patients who suffered chronic neuropathic pain for over 6 months with treatment code T093, T060, T061, T913, S141, S241, S246, S341, S342, M961, M890, G564, G5780, G5880, G5881, G546, G530, G500, G631, G632 3)Neuropathic pain did not respond to conventional treatment and could not be controlled after 4 weeks of pain relievers. 4)Treatments such as nerve blocker, epidural steroid injection, motor cortex or spinal cord stimulator failed to relieve the pain. 5)Numeral Rating Scale score of 5 or higher and Pain Disability Index of 30 or higher. 6)Patients capable of communicating about pain sensation. 7)Patients who are willing to participate and follow the clinical trial protocol.

Exclusion criteria

Exclusion criteria: 1)Adults between 19 years old and 75 years old 2)Patients who suffered chronic neuropathic pain for over 6 months with treatment code T093, T060, T061, T913, S141, S241, S246, S341, S342, M961, M890, G564, G5780, G5880, G5881, G546, G530, G500, G631, G632 3)Neuropathic pain did not respond to conventional treatment and could not be controlled after 4 weeks of pain relievers. 4)Treatments such as nerve blocker, epidural steroid injection, motor cortex or spinal cord stimulator failed to relieve the pain. 5)Numeral Rating Scale score of 5 or higher and Pain Disability Index of 30 or higher. 6)Patients capable of communicating about pain sensation. 7)Patients who are willing to participate and follow the clinical trial protocol.

Design outcomes

Primary

Measure	Time frame
Average NRS score will be evaluated before the treatment with the clinical equipment, 2 weeks, and 4 weeks after the treatment. Testing group and control group will be compared.;Changes in NRS scores will be evaluated from before treatment, 2 weeks, and 4 weeks after the treatment. The test group and the control group will be compared using Wilcoxon’s rank sum test (significance level 0.05). Average NRS scores will be evaluated from before treatment, 2 weeks, and 4 weeks after the treatment. The test group and the control group will be compared using Repeated measurement ANOVA (significance level of 0.05).	—

Measure

Time frame

Average NRS score will be evaluated before the treatment with the clinical equipment, 2 weeks, and 4 weeks after the treatment. Testing group and control group will be compared.;Changes in NRS scores will be evaluated from before treatment, 2 weeks, and 4 weeks after the treatment. The test group and the control group will be compared using Wilcoxon’s rank sum test (significance level 0.05). Average NRS scores will be evaluated from before treatment, 2 weeks, and 4 weeks after the treatment. The test group and the control group will be compared using Repeated measurement ANOVA (significance level of 0.05).

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Secondary

Measure	Time frame
Safety Evaluations	—

Countries

Korea, Republic of

Contacts

Public ContactDonghun Shin

Gachon University Gil Medical Center

dr.donghoon.shin@gmail.com+82-32-460-3346

Outcome results