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Evaluation of Peripheral Nerve Stimulation System to alleviate peripheral nerve pain associated with the effectiveness and safety of a prospective, multi-center, randomized, controlled, superiority clinical trial

Evaluation of Peripheral Nerve Stimulation System to alleviate peripheral nerve pain associated with the effectiveness and safety of a prospective, multi-center, randomized, controlled, superiority clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076816
Enrollment
Unknown
Registered
2023-10-19
Start date
2023-10-19
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

peripherally-induced neuropathic pain

Interventions

Experimental group:stimulation for the first seven days

Sponsors

Chinese People's Liberation Army Eastern Theater Command General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age =18 years old, gender unlimited; (2) peripheral nerve related pain; (3) 24-hour average pain (BIP#5) =5 points per day in the past 3 days; (4) Not participating in other clinical trials within the past 3 months; (5) Be able to understand the purpose of the test and voluntarily sign the informed consent; (6) The subjects are willing to undergo follow-up evaluation as required by the protocol.

Exclusion criteria

Exclusion criteria: (1) There is mental or cognitive impairment or no autonomous behavioral ability, unable to cooperate with researchers; An accurate assessment of the effectiveness and safety of the device; (2) Those who have implanted deep brain stimulation system, pacemaker, defibrillator and other stimulation current pathways overlapping with peripheral nerve stimulation electrodes; (3) diseases that increase the risk of infection (e.g. valvular heart disease, compromised immune system, history of recurrent skin infections); (4) analgesic drug dependence; (5) Patients who have undergone surgery within 1 month; (6) Patients who are allergic to tapes and adhesives; (7) Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period; (8) Those who were not considered suitable for inclusion by the researchers;

Design outcomes

Primary

MeasureTime frame
BPI#5;

Secondary

MeasureTime frame
Brief pain inventory (BPI);Beck depression inventory for depression evaluation;Patient Global Impression Change (PGIC) score;Drug usage;In-vivo retention rate of the peripheral nerve stimulation system;Investigator's evaluation of operational performance of investigational equipment;

Countries

China

Contacts

Public ContactJin Yi

Chinese People's Liberation Army Eastern Theater Command General Hospital

kimye@vip.163.com+86 138 5151 6946

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026