Non-Invasive Pulsed Radiofrequency for the Treatment of Neuropathic Pain

Conditions

• Pain, Nerve

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Active Treatment — DEVICE
  The treatment is a non-invasive pulsed radio frequency current that emits a high frequency magnetic field. It has a pulse width of 0.2ms, a pulse rate of 2Hz and an intensity between 0 - 30ma. There is a 'beep' sound as the pulses occur. There are 2 electrodes used - one is the indifferent electrode that is placed on the skin at a suitable distance away from the active electrode and the other, an active electrode - is a probe that is applied to the target nerve to treat the mononeuropathy
• Non-active Treatment — DEVICE
  The placebo device will be inert with nil current emitted however the device will look and be used in exactly the same way. There will also be a 'beep' sound emitted and only the investigator will know the difference. The placebo device will not deliver any electrical stimulation.

Study Details

The purpose of this study is to examine non-invasive pulsed radiofrequency (NIPRF) and the effect it has on chronic neuropathic pain. Chronic neuropathic pain after peripheral nerve injury most often occurs in the context of post-traumatic or post-surgical pain. It is often treated with nerve blocks, prescription medication, physical therapy, neuromodulation, and surgery. The study team will be examining the efficacy of NIPRF and determining if it would be an appropriate treatment for chronic neuropathic pain after peripheral nerve injury.The Stimpod used in the present study is FDA approved and will be used for on label purposes.

Key Dates

Start date

Nov 1, 2024

Status verified

Apr 2026

Primary completion

Jan 1, 2028

Completion

Jan 1, 2029

Study Design

Enrollment

95 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Active Comparator: Active Treatment
  ACTIVE treatment will be conducted by the study PIs, who are licensed pain physicians, Participants will receive 3 treatments, once weekly, for three weeks. Treatments are about 20 minutes long. The Stimpod being used is FDA cleared and is commercially available. The treatment is a non-invasive pulsed radio frequency current that emits a high frequency magnetic field. It has a pulse width of 0.2ms, a pulse rate of 2Hz and an intensity between 0 - 30ma. There is a 'beep' sound as the pulses occur. There are 2 electrodes used - one is the indifferent electrode that is placed on the skin at a suitable distance away from the active electrode and the other, an active electrode - is a probe that is applied to the target nerve to treat the mononeuropathy
• Sham Comparator: Non-Active Treatment
  Participants enrolled in the non-active arm will receive 3 treatments, once weekly, for three weeks. After the trial is completed, participants will be offered three free treatments. The placebo device will be inert with nil current emitted however the device will look and be used in exactly the same way. There will also be a 'beep' sound emitted and only the investigator will know the difference. The placebo device will not deliver any electrical stimulation.

Primary Outcome Measure

Treatment Response Rate [ Time Frame: After Three Weeks of Starting Treatment ]

Locations (1)

Find similar trials in Redwood City, CA

Related Studies

• Surgical Treatments for Postamputation Pain
  Recruiting · Prometei Pain Rehabilitation Center · Chicago, Illinois