TonsillitisBFANCT02571075

Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea

A study testing Auricular acupuncture in people with Tonsillitis, run by Defense and Veterans Center for Integrative Pain Management 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

The purpose of this study is to determine if auricular acupuncture significantly reduces post-operative pain in comparison to the standard of care. Post-operative pain score will be collected by subject self-report of pain according to the Numerical Rating Scale (NRS) (0= no pain, 10 = worst imaginable pain) up to 10… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Tonsillitis
What is being tested?: Auricular acupuncture
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 95 participants
Where: 1 siteUnited States
Study dates: Nov 2013to 23 Aug 2017
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All adults eighteen years of age or older having a tonsillectomy with or without adenoidectomy
Anesthesiologist classification one to three

Who cannot join

Chronic pain syndromes or pain symptoms lasting greater than three months or taking opioids on a daily basis for greater than four months
Anesthesiologist classification four
Prior neck or throat surgery
Allergy to gold

Trial locations and contacts

1 site in 1 country.

United States1 site

Womack Army Medical Center
Fort Bragg, North Carolina, 28310

Other trials in United States

About this study

Official title: A Randomized, Single-blind, Prospective Trial of Auricular Acupuncture for the Reduction of Post-operative Tonsillectomy Pain in Adults

Read the detailed description

DESIGN:

Design type: Prospective, randomized control trial Sample

Description of the population: All adults, greater than or equal to 18 years, undergoing a tonsillectomy with or without adenoidectomy at Womack Army Medical Center are eligible for participation in the study.
Sample Size: 100 subjects. A target of 45 subjects per group for a total of 90 subjects, and accounting for a 10 percent drop out rate. In Fiscal Year 12, 92 tonsilectomies in patients over the age of 12 were performed at Womack Army Medical Center. Therefore, the investigators anticipate the study will take up to 4 years to enroll 100 adult subjects.
Power Analysis: Under the assumption of a linear time by treatment interaction, assuming subject-level randomization, five time-points, power of 80 percent, a Type I error rate of 5 per cent and no attrition, to detect a 1.6 difference in pain score requires a total sample size of 90 subjects or 45 per treatment arm.

Conditions: Tonsillitis
Being tested: Auricular acupuncture
Keywords: auricular, acupuncture, pain
Medical subject headings: Tonsillitis, Pain

What participants receive

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

Auricular acupunctureOther
Also called "Battlefield Acupuncture" BFA
The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin.

Study groups in NCT02571075
Study group	Role	What they receive
Group 1 - Receives auricular acupuncture	Experimental	Receives "Battlefield Acupuncture" (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened. Receives: Other: Auricular acupuncture
Group 2 don't receive anything	No intervention	They do not receive any any acupuncture only standard of care.

What is being measured

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

Pain Scores
Pain scores will be collected daily during the post op period in the recovery room using a numbers scale with faces; specifically the Wong-Baker FACES® Pain Rating Scale where 10 is described as worst possible and 0 is No pain. This was recorded by the participant at home using the same type scale and this was is provided to them. The Hypothesis is that subjects receiving intraoperative auricular acupuncture during a tonsillectomy will have statistically significantly less post-operative pain scores compared to those that do not.
Measured: 10 days after the procedure.
The Morphine Equivalent of Opioid Use
The intraoperative and recovery room morphine equivalents will be calculated and upon diary return what use is recorded by the patient will be done as well. The participant is instructed to write down the type and amount they take throughout that time period.
Measured: Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system.

Secondary outcomes (3)

Return to Diet
Subjects will record on their diary the date they returned to a regular diet (defined to them what is regular for them)
Measured: Within 10 days post operatively
Number of Participants With Nausea Post Operatively
It will be documented yes or no if the participant voiced any complaint of nausea while in recovery.
Measured: 1-3 hours postoperativey
Number of Participants With Nausea Post Operatively
It will be documented yes or no if the participant had any emesis while in recovery prior to discharge home.
Measured: 1-3 hours post operatively

Timeline

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

Nov 201323 Aug 2017

First posted8 Oct 2015 (estimated)
Study startNov 2013
Primary completion8 Jun 2017
Study completion23 Aug 2017

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 TonsillitisStudies 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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02571075
Sponsor's protocol ID: 381600
Acronym: BFA
Status last verified: May 2020
First submitted: 2 Oct 2015
Last updated: 9 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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All Tonsillitis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-blind, Prospective Trial of Auricular Acupuncture for the Reduction of Post-operative Tonsillectomy Pain in Adults
ClinicalTrials.gov ID: NCT02571075
Acronym / sponsor ID: BFA / 381600
Conditions: Tonsillitis
Keywords: auricular, acupuncture, pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
Study start: Nov 2013
Primary completion: 8 Jun 2017 (actual)
Study completion: 23 Aug 2017 (actual)
First posted: 8 Oct 2015 (estimated)
Results: Posted 28 Aug 2019

Clinical summary

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

Detailed description

DESIGN:

Design type: Prospective, randomized control trial Sample

Description of the population: All adults, greater than or equal to 18 years, undergoing a tonsillectomy with or without adenoidectomy at Womack Army Medical Center are eligible for participation in the study.
Sample Size: 100 subjects. A target of 45 subjects per group for a total of 90 subjects, and accounting for a 10 percent drop out rate. In Fiscal Year 12, 92 tonsilectomies in patients over the age of 12 were performed at Womack Army Medical Center. Therefore, the investigators anticipate the study will take up to 4 years to enroll 100 adult subjects.
Power Analysis: Under the assumption of a linear time by treatment interaction, assuming subject-level randomization, five time-points, power of 80 percent, a Type I error rate of 5 per cent and no attrition, to detect a 1.6 difference in pain score requires a total sample size of 90 subjects or 45 per treatment arm.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Group 1 - Receives auricular acupuncture	Experimental	Other: Auricular acupunctureReceives "Battlefield Acupuncture" (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened.
Group 2 don't receive anything	No intervention	–They do not receive any any acupuncture only standard of care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

All adults eighteen years of age or older having a tonsillectomy with or without adenoidectomy
Anesthesiologist classification one to three

Key exclusion criteria (4 listed)

Chronic pain syndromes or pain symptoms lasting greater than three months or taking opioids on a daily basis for greater than four months
Anesthesiologist classification four
Prior neck or throat surgery
Allergy to gold

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
Auricular acupunctureAlso: "Battlefield Acupuncture" BFAThe ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin.	Other	Group 1 - Receives auricular acupuncture

Primary outcome

Pain Scores
Time frame: 10 days after the procedure.
Pain scores will be collected daily during the post op period in the recovery room using a numbers scale with faces; specifically the Wong-Baker FACES® Pain Rating Scale where 10 is described as worst possible and 0 is No pain. This was recorded by the participant at home using the same type scale and this was is provided to them. The Hypothesis is that subjects receiving intraoperative auricular acupuncture during a tonsillectomy will have statistically significantly less post-operative pain scores compared to those that do not.
The Morphine Equivalent of Opioid Use
Time frame: Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system.
The intraoperative and recovery room morphine equivalents will be calculated and upon diary return what use is recorded by the patient will be done as well. The participant is instructed to write down the type and amount they take throughout that time period.

3 secondary outcomes

Return to Diet
Time frame: Within 10 days post operatively
Number of Participants With Nausea Post Operatively
Time frame: 1-3 hours postoperativey
Number of Participants With Nausea Post Operatively
Time frame: 1-3 hours post operatively

Results and safety

Results posted to the registry on 28 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 - Receives Auricular Acupuncture	45	25
Group 2 Don't Receive Anything	50	26

Primary outcome: Pain Scores

Time frame: 10 days after the procedure.. Mean (Standard Deviation). Unit: units on a scale

Measure	Group 1 - Receives Auricular Acupuncture n = 45	Group 2 Don't Receive Anything n = 50
Pain at discharge	1.3 (1.6)	1.4 (1.6)
Pain at 6 hours post discharge	5.1 (1.6)	5.9 (2.1)
12 hours post discharge	5.5 (1.9)	6.4 (1.9)
18hrs post discharge	5.4 (1.7)	6.4 (1.6)
24 hrs post discharge	5.3 (2.1)	6.0 (2.1)
day 2 of discharge	6.1 (1.9)	6.5 (2.0)
day 3 of discharge	5.8 (2.1)	6.4 (2.2)
day 4 of discharge	5.6 (1.9)	5.6 (1.9)

Population analysed: Only a 50 % diary return completing the full 10 day diary data but had the full inpatient data

Primary outcome: The Morphine Equivalent of Opioid Use

Time frame: Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system.. Mean (Standard Deviation). Unit: mg

Measure	Group 1 - Receives Auricular Acupuncture n = 45	Group 2 Don't Receive Anything n = 50
Oral morphine equivalent in OR in mg	63.8 (2407)	70.5 (24.0)
oral morphine equivalent in PACU in mg	9.1 (20.0)	7.4 (10.9)
oral morphine equivalent in mg 10 days post discha	257.3 (341.7)	295.7 (257.8)
oral morphine equivalent total OR+ PACU+Home	334.3 (339.4)	376.2 (254.3)

Population analysed: Some results based on 10 day diary return but inpatient data available on all subjects

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 years from first enrolled to final participant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 - Receives Auricular Acupuncture	0 of 45 (0%)	2 of 45 (4.4%)	0 of 45
Group 2 Don't Receive Anything	0 of 50 (0%)	3 of 50 (6%)	0 of 50

Limitations and caveats (from the sponsor): Of the 95 enrolled there was only a 50% diary return of the 10 day diaries and not all of those were complete.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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.

Anthony R Plunkett, MD principal investigator

Womack Army Medical Center Fort Bragg

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

Questions about this trial

What is this clinical trial studying?

A study testing Auricular acupuncture in people with Tonsillitis, run by Defense and Veterans Center for Integrative Pain Management 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 4 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 9 Jun 2020. 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 28 Aug 2019). 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?

Pain Scores (time frame: 10 days after the procedure.). 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 NCT02571075.

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 9 Jun 2020.