Peripheral NeuropathyFRT-PNNCT03540446
First Relief Treatment for Peripheral Neuropathy
A study testing First Relief Treatment in people with Peripheral Neuropathy, run by DyAnsys, Inc. at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- First Relief Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIndia
- Study dates
- 4 Apr 2018to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Neuropathy pain
Who cannot join
- Patient with inbuilt pacemakers or any other devices which allows current into the body, pregnant ladies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Peripheral Neuropathy
- Being tested
- First Relief Treatment
- Keywords
- First Relief, Diebetes, Pheripheral Neuropathy, Pain Releif
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First Relief TreatmentDevice
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 group | Role | What they receive |
|---|---|---|
| Standard stimulation | Experimental | Group A will be treated with First Relief Treatment at standard stimulation. Receives: Device: First Relief Treatment |
| sweep stimulation | Experimental | Group B will be treated with First Relief Treatment at sweep stimulation. Receives: Device: First Relief Treatment |
| Placebo | Experimental | Group C will be treated with First Relief Treatment, receiving a placebo.(dummy device with no electrical stimulation) Receives: Device: First Relief Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start4 Apr 2018
- Primary completion15 Sep 2018
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- DyAnsys, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Gurunath, Ph.D, Study director, Jeevak hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540446
- Sponsor's protocol ID
- FRT-PN-18
- Acronym
- FRT-PN
- Status last verified
- Sep 2018
- First submitted
- 24 Apr 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Prove the Effectiveness of PENS Therapy With Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03540446
- Acronym / sponsor ID
- FRT-PN / FRT-PN-18
- Conditions
- Peripheral Neuropathy
- Keywords
- First Relief, Diebetes, Pheripheral Neuropathy, Pain Releif
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- DyAnsys, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- Oct 2018 (estimated)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard stimulation | Experimental | Device: First Relief TreatmentGroup A will be treated with First Relief Treatment at standard stimulation. |
| sweep stimulation | Experimental | Device: First Relief TreatmentGroup B will be treated with First Relief Treatment at sweep stimulation. |
| Placebo | Experimental | Device: First Relief TreatmentGroup C will be treated with First Relief Treatment, receiving a placebo.(dummy device with no electrical stimulation) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Neuropathy pain
Key exclusion criteria (1 listed)
- Patient with inbuilt pacemakers or any other devices which allows current into the body, pregnant ladies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First Relief TreatmentTo prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the treatment of conditions associated with peripheral neuropathy, in a double-blind environment. | Device | Placebo, Standard stimulation, sweep stimulation |
Primary outcome
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.
1 secondary outcome
Check for delay of Re-occurrence of pain within a short time
Time frame: 90 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Peripheral Neuropathy
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Recruiting
Effect of TMS on Neuropathic Pain for Patients With Spinal Cord Injury
Spinal Cord Injury, Neuropathic Pain
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Not yet recruiting
Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy: A Randomized Controlled Trial
Cervical Radiculopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Gurunath, Ph.D study director
Jeevak hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First Relief Treatment in people with Peripheral Neuropathy, run by DyAnsys, Inc. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Neuropathy pain (time frame: According to the patients condition and other factors expected to reduce pain in 4th week of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2018.