First Relief Treatment for Peripheral Neuropathy
FRT-PN
To Prove the Effectiveness of PENS Therapy With Peripheral Neuropathy
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2018
CompletedFirst Submitted
Initial submission to the registry
April 24, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedSeptember 24, 2018
September 1, 2018
5 months
April 24, 2018
September 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Check for delay of Re-occurrence of pain within a short time
90 Days
Other Outcomes (1)
Complete reduction of conditions associated with peripheral neuropathy
7 weeks
Study Arms (3)
Standard stimulation
EXPERIMENTALGroup A will be treated with First Relief Treatment at standard stimulation.
sweep stimulation
EXPERIMENTALGroup B will be treated with First Relief Treatment at sweep stimulation.
Placebo
EXPERIMENTALGroup C will be treated with First Relief Treatment, receiving a placebo.(dummy device with no electrical stimulation)
Interventions
To prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the treatment of conditions associated with peripheral neuropathy, in a double-blind environment.
Eligibility Criteria
You may qualify if:
- Patients with Neuropathy pain
You may not qualify if:
- Patient with inbuilt pacemakers or any other devices which allows current into the body, pregnant ladies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DyAnsys, Inc.lead
Study Sites (1)
Clinic
Warangal, Telangana, 506002, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Gurunath, Ph.D
Jeevak hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2018
First Posted
May 30, 2018
Study Start
April 4, 2018
Primary Completion
September 15, 2018
Study Completion
October 1, 2018
Last Updated
September 24, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share