First Relief Treatment for Peripheral Neuropathy (FRT-PN)

DyAnsys

Status: Unknown

Conditions: Peripheral Neuropathy

Treatments: Device: First Relief Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03540446

FRT-PN-18

Details and patient eligibility

About

To prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the treatment of conditions associated with peripheral neuropathy, in a double-blind environment.

Enrollment: 66 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Neuropathy pain

Exclusion criteria

• Patient with inbuilt pacemakers or any other devices which allows current into the body, pregnant ladies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

66 participants in 3 patient groups

Standard stimulation

Experimental group

Description:

Group A will be treated with First Relief Treatment at standard stimulation.

Treatment:

Device: First Relief Treatment

sweep stimulation

Experimental group

Description:

Group B will be treated with First Relief Treatment at sweep stimulation.

Treatment:

Device: First Relief Treatment

Placebo

Experimental group

Description:

Group C will be treated with First Relief Treatment, receiving a placebo.(dummy device with no electrical stimulation)

Treatment:

Device: First Relief Treatment