First Relief Treatment for Peripheral Neuropathy (FRT-PN)

September 20, 2018 updated by: DyAnsys, Inc.

To Prove the Effectiveness of PENS Therapy With Peripheral Neuropathy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Telangana
      • Warangal, Telangana, India, 506002
        • Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Neuropathy pain

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard stimulation
Group A will be treated with First Relief Treatment at standard stimulation.
Device: First 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.
Experimental: sweep stimulation
Group B will be treated with First Relief Treatment at sweep stimulation.
Device: First 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.
Experimental: Placebo
Group C will be treated with First Relief Treatment, receiving a placebo.(dummy device with no electrical stimulation)
Device: First 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Neuropathy pain
Time Frame: According to the patients condition and other factors expected to reduce pain in 4th week of the treatment
This 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.
According to the patients condition and other factors expected to reduce pain in 4th week of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Check for delay of Re-occurrence of pain within a short time
Time Frame: 90 Days
After 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
90 Days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete reduction of conditions associated with peripheral neuropathy
Time Frame: 7 weeks
After 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.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DyAnsys, Inc.

Investigators

  • Study Director: Dr. Gurunath, Ph.D, Jeevak hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2018

Primary Completion (Actual)

September 15, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRT-PN-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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