PainNCT01495286

Safety of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) in Infants

A study testing EMPI Select Transcutaneous Electrical Nerve Stimulation in people with Pain, run by University of Arkansas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 day to 3 days
Conditions the study is for: Pain
What is being tested?: EMPI Select Transcutaneous Electrical Nerve Stimulation
Type of treatment: Medical device
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Dec 2011to Jul 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 day to 3 days
All sexes
No healthy volunteers
Child

Who may be able to join

Newborn infants born at 37-42 weeks gestational age and less than 3 days of age requiring a heelstick for clinically indicated blood sampling.
A normal neurological assessment

Who cannot join

Newborns who have received any analgesic treatment
Infants exposed to chronic opiates in utero (excluding opiates given only at the time of delivery) or with a positive drug screen based on review of medical records
Infants exposed to birth asphyxia (5-minute Apgar scores of <5 or cord pH <7.0).
Infants on mechanical ventilation.
Newborns with suspected or confirmed neuromuscular diseases, congenital anomalies, or sepsis.
Infants with birth trauma to the lower extremities (bruising or other) or those exposed multiple heelsticks in the previous 24 hours (e.g. requiring frequent glucose or bilirubin measurements).

Show all 16Show fewer

Infants born from mothers with drug addiction, diabetes, pre-eclampsia, or systemic inflammatory conditions.
Infants with abnormal neurological exams
Infants with congenital heart defects
Any condition the investigator determines will put the subject at risk if participating in the study.
Enrollment / participation in other studies
Dermatological condition(s) in the area of electrode placement or elsewhere
Local or systemic infection documented or suspected
Allergy to the gel or adhesive
Bleeding abnormalities
Connection to other medical equipment or devices that may interfere with the workings or functioning of the TENS unit

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: Is the Use of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) During a Routine Heelstick Safe in Infants?

This research study represents a pilot, open arm study that will evaluate the safety of using Non-invasive Electrical Stimulation of Acupuncture Points (NESAP) in 42 newborn infants less than 3 days of age who require heel sticks for clinical blood sampling. The investigators plan to enroll 51 infants into the study in order to obtain 42 completed infants. Two sub studies will precede the main safety study, with 6 infants in each sub study and 30 infants in the main study. These two sub studies will use electrical stimulation intensities that are a fraction of the planned intensity of electrical stimulation that will be used during the main part of the study.

The clinical trial will be performed at the University of Arkansas for Medical Sciences Hospital (Little Rock, AR). The study will evaluate the pain response to heel stick routinely used to obtain This blood from 30 term neonatal infants, ages 37 to 42 weeks Electrical stimulation will be applied at appropriate acupuncture points using a very low current for 10 minutes, routine for procedural pain. The response to pain will be assessed using pain scales and physiologic changes.

The investigators hypothesize that the NESAP procedure is safe in newborn infants undergoing a routine heelstick.

Read the detailed description

The investigators propose an open label trial to assess the safety of using electrical stimulation at acupuncture sites in 42 infants receiving a routine heel stick. Two sub studies will precede the main safety study, with 6 infants in each sub study and 30 infants in the main study. These sub studies will use electrical stimulation intensities that are a fraction of the planned intensity of the electrical stimulation that will be used for the main part of the study.

As part of routine neonatal screening, blood will be collected from a heel stick(s) by qualified nursing staff in the hospital nursery or in the patient's room. Less than one ml of blood will be drawn over 1-2 minutes. Study infants will be watched more carefully with heart rate, respiratory rate, and oxygen saturation performed as part of this study. Infants not participating in the study will be watched as per usual unit protocol.

Electrical stimulation at acupuncture sites will be administered via an EMPI Select Transcutaneous Electrical Nerve Stimulation (TENS) unit. To produce analgesia, small electrodes will be placed on the baby's legs at specific acupuncture points: ZuSanLi (ST36) just below the knee, triggers release of endorphins; SanYinJiao (SP6) just above the inner ankle, important point for energy balance; Kun Lun (BL60) depression behind lateral malleolus, protects local tissue trauma to heel; and Tai Xi (Ki3) behind the inner ankle, an important energy meridian. 25, 39, 48-50, StimCare self-adhesive electrodes with a gel base will be applied to the skin; the skin will not be punctured by these procedures. For the main part of the study, a low continuous current will be provided with minimal voltage of 3.5 milliamps (mA). The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 5±1 min after the heelstick. This paradigm is based on the basic animal research developed by Dr. Han and other research groups. Two sub studies will precede the main safety study, with 6 infants in each sub study, using electrical stimulation intensities that are a fraction of the planned intensity. Infants in sub study 1 will receive electrical stimulation at 1 mA and 2 Hz. Infants in sub study 2 will receive electrical stimulation at 2 mA and 10 Hz.

Conditions: Pain
Being tested: EMPI Select Transcutaneous Electrical Nerve Stimulation
Keywords: newborn infant, acupuncture, safety, pain
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EMPI Select Transcutaneous Electrical Nerve StimulationDevice
Also called Noninvasive electrical stimulation
Experimental: EMPI Select TENS unit For analgesia, StimCare electrodes will be placed on the baby's legs at specific acupuncture points and electrical stimulation will be administered via a standard EMPI Select TENS unit. For the main study, a low continuous current will be provided with voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 5±1 min after the heel stick. Two sub studies will precede the main safety study, with 6 infants in each, using electrical stimulation intensities that are a fraction of the planned intensity. Infants in sub study 1 will receive electrical stimulation at 1 mA and 2 Hz. Infants in sub study 2 will receive electrical stimulation at 2 mA and 10 Hz.

What is being measured

The primary outcome is the main question the study is designed to answer.

Heart Rate During Treatment With TENS Unit
Changes in heart rate will be recorded after an initial baseline heart rate. Heart rate will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.
Measured: Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.
Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick
Changes in oxygen saturation after an initial baseline oxygen saturation. Oxygen saturation will be measured after TENS unit is initiated, for 10 minutes between TENS initiation and heel stick,during heel stick, and for 5 minutes afterwards. Measurements will be taken at baseline, after 5 minutes of NESAP, and at 5 minutes after end of heel stick.
Measured: Baseline, duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.

Secondary outcomes (3)

Blood Pressure During TENS Treatment and Heel Stick
Changes in systolic and diastolic blood pressure after initial baseline. Measurements will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.
Measured: Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.
Pain During TENS Treatment and Routine Heel Stick
Pain scores were measured using the Premature Infant Pain Profile (PIPP). The PIPP is a composite pain tool that measures pain based on behavioral and physiologic parameters and adjusts for gestational age. Differences in pain scores were recorded throughout the heel stick process, using a baseline score as reference. Mean pain scores were calculated before NESAP (baseline), after the TENS unit was turned on, after ten minutes of NESAP but before heel stick, during heel cleaning, during the initial heel stick, during heel squeeze, and during recovery. For term infants, the range of PIPP scores is on a scale of 0 for no pain to 18 for severe pain. A score of 6 indicate mild pain, and a score of 11 -12 indicates moderate pain. An increase in PIPP score of 4 or greater from baseline indicates a significant change in pain level.
Measured: Pain score given during the heel stick process and for 2 minutes afterwards
Skin Assessment
Areas of skin where the Stim Care electrodes are placed will be assessed for redness, tenderness, or any other change in skin condition. Assessment will take place at baseline, after the NESAP procedure, upon discharge from the hospital, and after one week. If there is a problem at one week, there will be additional follow-up at two weeks.
Measured: Post procedure monitoring for the duration of the hospital stay, an expected average of 1 day. Follow up phone calls at one week and again at two weeks if needed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jul 2012

First posted20 Dec 2011 (estimated)
Study startDec 2011
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
More trials run by University of ArkansasThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01495286
Sponsor's protocol ID: 114283
Status last verified: Oct 2012
First submitted: 9 Dec 2011
Last updated: 19 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Is the Use of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) During a Routine Heelstick Safe in Infants?
ClinicalTrials.gov ID: NCT01495286
Acronym / sponsor ID: 114283
Conditions: Pain
Keywords: newborn infant, acupuncture, safety, pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of ArkansasUniversity, hospital or other
Collaborators: Stanford University
Study start: Dec 2011
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 20 Dec 2011 (estimated)
Results: Posted 19 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators hypothesize that the NESAP procedure is safe in newborn infants undergoing a routine heelstick.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 1 day to 3 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Newborn infants born at 37-42 weeks gestational age and less than 3 days of age requiring a heelstick for clinically indicated blood sampling.
A normal neurological assessment

Key exclusion criteria (16 listed)

Newborns who have received any analgesic treatment
Infants exposed to chronic opiates in utero (excluding opiates given only at the time of delivery) or with a positive drug screen based on review of medical records
Infants exposed to birth asphyxia (5-minute Apgar scores of <5 or cord pH <7.0).
Infants on mechanical ventilation.
Newborns with suspected or confirmed neuromuscular diseases, congenital anomalies, or sepsis.

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
EMPI Select Transcutaneous Electrical Nerve StimulationAlso: Noninvasive electrical stimulationExperimental: EMPI Select TENS unit For analgesia, StimCare electrodes will be placed on the baby's legs at specific acupuncture points and electrical stimulation will be administered via a standard EMPI Select TENS unit. For the main study, a low continuous current will be provided with voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 5±1 min after the heel stick. Two sub studies will precede the main safety study, with 6 infants in each, using electrical stimulation intensities that are a fraction of the planned intensity. Infants in sub study 1 will receive electrical stimulation at 1 mA and 2 Hz. Infants in sub study 2 will receive electrical stimulation at 2 mA and 10 Hz.	Device	–

Primary outcome

Heart Rate During Treatment With TENS Unit
Time frame: Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.
Changes in heart rate will be recorded after an initial baseline heart rate. Heart rate will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.
Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick
Time frame: Baseline, duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.
Changes in oxygen saturation after an initial baseline oxygen saturation. Oxygen saturation will be measured after TENS unit is initiated, for 10 minutes between TENS initiation and heel stick,during heel stick, and for 5 minutes afterwards. Measurements will be taken at baseline, after 5 minutes of NESAP, and at 5 minutes after end of heel stick.

3 secondary outcomes

Blood Pressure During TENS Treatment and Heel Stick
Time frame: Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.
Pain During TENS Treatment and Routine Heel Stick
Time frame: Pain score given during the heel stick process and for 2 minutes afterwards
Skin Assessment
Time frame: Post procedure monitoring for the duration of the hospital stay, an expected average of 1 day. Follow up phone calls at one week and again at two weeks if needed.

Results and safety

Results posted to the registry on 19 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Noninvasive Electrical Stimulation Acupuncture Points (NESAP)	30	30

Primary outcome: Heart Rate During Treatment With TENS Unit

Time frame: Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.. Mean (Standard Deviation). Unit: beats per minute

Measure	Noninvasive Electrical Stimulation Acupuncture Points (NESAP) n = 30
Baseline heart rate	137 (11.9)
Heart rate after 5 minutes of NESAP	131 (15)
Heart rate 5 minutes after heelstick	133 (15)
Heart rate after return to room	133 (15)

Population analysed: We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.

Primary outcome: Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick

Time frame: Baseline, duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.. Mean (Standard Deviation). Unit: percentage of oxygen saturation

Measure	Noninvasive Electrical Stimulation Acupuncture Points (NESAP) n = 30
Oxygen saturation before NESAP	98 (1.55)
Oxygen saturation after 5 minutes of NESAP	97 (2.18)
Oxygen saturation 5 minutes after heel stick	96 (2.3)

Population analysed: We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant increase in pain level. With 30 infants, we had 90% power to detect a significant increase in PIPP score with a .05 level, one-sided paired t-test.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Noninvasive Electrical Stimulation Acupuncture Points (NESAP)	0 of 30 (0%)	0 of 30 (0%)	Not reported

Limitations and caveats (from the sponsor): This was a small pilot study to determine safety of a TENS unit to deliver NESAP to newborn infants during routine heel sticks. The purpose was not to determine efficacy of NESAP to relieve pain during heel sticks. A large clinical trial will follow.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Richard Hall, MD principal investigator

University of Arkansas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EMPI Select Transcutaneous Electrical Nerve Stimulation in people with Pain, run by University of Arkansas at 1 site in United States.

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 2 inclusion and 16 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: finished, as of the sponsor's last update on 19 Nov 2012. 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 United States. 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?

Yes. Results are posted in the registry (first posted 19 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Heart Rate During Treatment With TENS Unit (time frame: Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01495286.

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 19 Nov 2012.