Back to resultsFirst Relief Treatment for Peripheral Neuropathy (FRT-PN)
Primary Purpose
Peripheral Neuropathy
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
First Relief Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathy focused on measuring First Relief, Diebetes, Pheripheral Neuropathy, Pain Releif
Eligibility Criteria
Inclusion Criteria:
- Patients with Neuropathy pain
Exclusion Criteria:
- Patient with inbuilt pacemakers or any other devices which allows current into the body, pregnant ladies.
Sites / Locations
- Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Standard stimulation
sweep stimulation
Placebo
Arm Description
Group A will be treated with First Relief Treatment at standard stimulation.
Group B will be treated with First Relief Treatment at sweep stimulation.
Group C will be treated with First Relief Treatment, receiving a placebo.(dummy device with no electrical stimulation)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03540446
Brief Title
First Relief Treatment for Peripheral Neuropathy
Acronym
FRT-PN
Official Title
To Prove the Effectiveness of PENS Therapy With Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
September 15, 2018 (Actual)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DyAnsys, Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
Keywords
First Relief, Diebetes, Pheripheral Neuropathy, Pain Releif
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard stimulation
Arm Type
Experimental
Arm Description
Group A will be treated with First Relief Treatment at standard stimulation.
Arm Title
sweep stimulation
Arm Type
Experimental
Arm Description
Group B will be treated with First Relief Treatment at sweep stimulation.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Group C will be treated with First Relief Treatment, receiving a placebo.(dummy device with no electrical stimulation)
Intervention Type
Device
Intervention Name(s)
First Relief Treatment
Intervention Description
To prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the treatment of conditions associated with peripheral neuropathy, in a double-blind environment.
Primary Outcome Measure Information:
Title
Reduction of Neuropathy pain
Description
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.
Time Frame
According to the patients condition and other factors expected to reduce pain in 4th week of the treatment
Secondary Outcome Measure Information:
Title
Check for delay of Re-occurrence of pain within a short time
Description
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
Time Frame
90 Days
Other Pre-specified Outcome Measures:
Title
Complete reduction of conditions associated with peripheral neuropathy
Description
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.
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Neuropathy pain
Exclusion Criteria:
Patient with inbuilt pacemakers or any other devices which allows current into the body, pregnant ladies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Gurunath, Ph.D
Organizational Affiliation
Jeevak hospital
Official's Role
Study Director
Facility Information:
Facility Name
Clinic
City
Warangal
State/Province
Telangana
ZIP/Postal Code
506002
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
First Relief Treatment for Peripheral Neuropathy
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