Actively Recruiting
Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device for Chronic Knee, Elbow, or Shoulder Pain
Led by Nervonik · Updated on 2026-04-13
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the Nervonik peripheral nerve stimulation device in adults experiencing chronic severe pain in the knee, elbow, or shoulder areas. The study focuses on patients with peripheral nerve disorders causing significant pain, including post-surgical or traumatic nerve pain. It is an early-phase, multicenter trial involving 30 patients to assess the device's potential for pain relief. Participants are divided into two groups. The first group will use the Nervonik neurostimulator for up to 8 hours while staying near the care facility to allow adjustments until satisfactory pain relief is achieved, after which the device will be removed. The second group includes patients from the first group who found the device beneficial and agree to a permanent implant, as well as new patients meeting the trial criteria who consent to participate. During the study, participants will undergo evaluations to monitor pain relief and device effectiveness over different time periods—an average of 1 day for the first group and an average of 1 year for the second group. Researchers will collect data through study visits, monitor stable pain and medication use, and assess safety. The entire participation period varies depending on the group and treatment phase.
CONDITIONS
Brief Title
Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 to 80 years at enrollment
- Diagnosed with chronic knee, arm, or shoulder pain with a pain score of at least 5 out of 10
- Chronic pain related to post-surgical or post-traumatic peripheral neuralgia, nerve injury, scar formation, nerve entrapment, mononeuropathy, or other neuropathic pain
- Willing to comply with study procedures and complete all visits
- Stable, non-escalating pain for 60 days before consent
- Stable pain medication use and dosage for 30 days before consent
- Psychologically qualified to receive a peripheral nerve stimulator without interfering conditions
- Able to properly place or use the wearable device components as instructed
You will not qualify if you...
- Having an active implantable medical device like a drug pump, spinal cord stimulator, or pacemaker
- Previous failure of peripheral nerve stimulation or spinal cord stimulation therapies
- Pain completely absent at rest
- Diagnosis of complex regional pain syndrome, metabolic neuropathy, post-herpetic neuralgia, or certain genetic neuropathies
- Medical conditions preventing study participation as judged by investigators
- Successful interventional procedure for the same pain in past 3 months
- Uncontrolled depression or psychiatric disorders
- Participation in another active treatment clinical trial
- Allergic or sensitive to device materials or unable to tolerate the wearable
- Pending legal or compensation issues related to pain condition
- Coagulation disorders or progressive vascular disease not corrected
- Active systemic infection
- Unable to read/write Spanish or give informed consent
- Life expectancy under 1 year
- Active cancer or paraneoplastic syndrome
- Uncontrolled diabetes with neuropathy
- Recent alcohol or drug dependency
- Pregnancy or breastfeeding; females must use birth control if sexually active
- Taking over 90 mg morphine equivalent daily
- Prior ablative treatments on target nerves or related nerve roots except certain approved procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 hours for initial cohort; up to 1 year for permanent implant cohort
Participants receive the Nervonik peripheral nerve stimulator device to manage chronic knee, elbow, or shoulder pain. The initial cohort will have the device implanted temporarily for up to 8 hours with program adjustments until satisfactory pain relief is achieved. The device will then be removed at the end of the evaluation. Participants in the second cohort may receive a permanent implant if suitable pain relief is confirmed.
Multiple visits for implant programming and evaluation, including device removal or permanent implantation
Trial Site Locations
Total: 1 location
1
Hospital Punta Pacifica
Panama City, Provincia de Panamá, Panama, 0831-01593
Actively Recruiting
Research Team
D
Depatment Chairman, Neurology
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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