First Relief Treatment for Peripheral Neuropathy

Peripheral Neuropathy Clinical Trial

— FRT-PN  

Official title:

To Prove the Effectiveness of PENS Therapy With Peripheral Neuropathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03540446
• Other study ID #: FRT-PN-18
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: October 2018

Study information

• Verified date: September 2018
• Source: DyAnsys, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: October 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with Neuropathy pain

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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.

Locations

Country	Name	City	State
India	Clinic	Warangal	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
DyAnsys, Inc.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complete reduction of conditions associated with peripheral neuropathy	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
Primary	Reduction of Neuropathy pain	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	Check for delay of Re-occurrence of pain within a short time	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