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First Relief Treatment for Peripheral Neuropathy

To Prove the Effectiveness of PENS Therapy With Peripheral Neuropathy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03540446
Acronym
FRT-PN
Enrollment
66
Registered
2018-05-30
Start date
2018-04-04
Completion date
2018-10-31
Last updated
2018-09-24

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

Conditions

Peripheral Neuropathy

Keywords

First Relief, Diebetes, Pheripheral Neuropathy, Pain Releif

Brief summary

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

Interventions

DEVICEFirst Relief Treatment

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

Sponsors

DyAnsys, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients with Neuropathy pain

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Reduction of Neuropathy painAccording to the patients condition and other factors expected to reduce pain in 4th week of the treatmentThis treatments effective outcome will be, Percutaneous Electrical Nerve Stimulation therapy will have the ability to reduce the pain and other conditions regarding peripheral neuropathy which can be verified through Biothesiometer parameters.

Secondary

MeasureTime frameDescription
Check for delay of Re-occurrence of pain within a short time90 DaysAfter the treatment of 4th week the pain will be reduced and the treatment is continued for other 3 weeks where the booster dose is applied for the assurance of delay of pain which is evaluated manually by the medical personals after 90 days of booster dose treatment

Other

MeasureTime frameDescription
Complete reduction of conditions associated with peripheral neuropathy7 weeksAfter the overall treatment has been completed the conditions associated with peripheral neuropathy will be completely reduced and the occurrence of the pain will be stopped which can be verified and evaluated through Biothesiometer parameters.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026