Recurrent TonsillitisNCT01790477
Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain
A study testing Auricular Acupuncture in people with Recurrent Tonsillitis and Peritonsillar Abscess, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
The goal of this study is to assess the role of battlefield acupuncture in the reduction of pain scores status post adult tonsillectomy. Secondary goals of this study include reduction in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend an increased risk of worsening pain or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recurrent Tonsillitis, Peritonsillar Abscess, Obstructive Sleep Apnea
- What is being tested?
- Auricular Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Feb 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any adult patient who meets criteria and is scheduled for tonsillectomy
Who cannot join
- Any patient with prior use of acupuncture
- Individuals under age 18
- Tonsillectomy performed with other surgical procedures, i.e UPPP, adenoidectomy,
- Patients with a known personal or family history of a bleeding disorder will be excluded.
- Patients with a history of kidney or liver problems will also be excluded.
- Patients found to be pregnant will be excluded from participation.
- Patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to assess the role of battlefield acupuncture in the reduction of pain scores status post adult tonsillectomy. Secondary goals of this study include reduction in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend an increased risk of worsening pain or improved response with acupuncture.
- Being tested
- Auricular Acupuncture
- Keywords
- Tonsillectomy, Acupuncture
- Medical subject headings
- Tonsillitis, Peritonsillar Abscess, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupunctureProcedure or surgery
Application of auricular acupuncture to 5 points on the ear
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupuncture | Experimental | Use of auricular acupuncture in bilateral ears Receives: Procedure: Auricular Acupuncture |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in VAS scores between experimental and control group
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Anil Shah, Principal investigator, NMCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790477
- Sponsor's protocol ID
- NMCSD.2012.0102
- Status last verified
- Apr 2016
- First submitted
- 11 Feb 2013
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain
- ClinicalTrials.gov ID
- NCT01790477
- Acronym / sponsor ID
- NMCSD.2012.0102
- Keywords
- Tonsillectomy, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Nov 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Feb 2013 (estimated)
- 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.
The goal of this study is to assess the role of battlefield acupuncture in the reduction of pain scores status post adult tonsillectomy. Secondary goals of this study include reduction in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend an increased risk of worsening pain or improved response with acupuncture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupuncture | Experimental | Procedure: Auricular AcupunctureUse of auricular acupuncture in bilateral ears |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult patient who meets criteria and is scheduled for tonsillectomy
Key exclusion criteria (7 listed)
- Any patient with prior use of acupuncture
- Individuals under age 18
- Tonsillectomy performed with other surgical procedures, i.e UPPP, adenoidectomy,
- Patients with a known personal or family history of a bleeding disorder will be excluded.
- Patients with a history of kidney or liver problems will also be excluded.
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 AcupunctureApplication of auricular acupuncture to 5 points on the ear | Procedure or surgery | Auricular Acupuncture |
Primary outcome
Reduction in VAS scores between experimental and control group
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Recurrent Tonsillitis
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Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
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SUPRATHEL 250 as a Treatment for Oropharyngeal Wounds
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Recovery From Tonsil Surgery.
Recurrent Tonsillitis, Chronic Tonsillitis
Active, not recruiting
Intracapsular Tonsillectomy in Adults
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The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
Tonsillitis Chronic, Tonsillitis Recurrent
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.
Anil Shah principal investigator
NMCSD
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 Recurrent Tonsillitis and Peritonsillar Abscess, run by United States Naval Medical Center, San Diego 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 1 inclusion and 7 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 6 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in VAS scores between experimental and control group (time frame: 2 weeks). 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 6 Apr 2016.