Hyperbaric Oxygen TherapyNCT04311437
Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy
A study testing Self-acupressure therapy and Combined Valsalva and Toynbee maneuvers in people with Hyperbaric Oxygen Therapy and Middle Ear Barotrauma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Middle ear barotrauma (MEB) is the most common complication during hyperbaric oxygen therapy (HBOT). Though Valsalva and Toynbee maneuvers have been proposed to prevent MEB, still some patients discontinue HBOT due to severe otalgia, hemorrhage or perforation of tympanic membrane associated with HBOT. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperbaric Oxygen Therapy, Middle Ear Barotrauma
- What is being tested?
- Self-acupressure therapy and Combined Valsalva and Toynbee maneuvers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2020to 28 Feb 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20 years or order receiving the first HBOT
- Alert consciousness
Who cannot join
- Pregnancy
- Having any acute disorder of the ears or upper respiratory tract
- Having evidence of neurologic dysfunction precluding them from making an informed decision
- Having a tracheostomy or endotracheal intubation
- Having received a myringotomy, tympanoplasty, mastoidectomy or tympanostomy tube placement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy: a Nonrandomized Clinical Trial
Middle ear barotrauma (MEB) is the most common complication during hyperbaric oxygen therapy (HBOT). Though Valsalva and Toynbee maneuvers have been proposed to prevent MEB, still some patients discontinue HBOT due to severe otalgia, hemorrhage or perforation of tympanic membrane associated with HBOT. Currently, there is no optimal prophylactic management for MEB associated with HBOT. The aim of this protocol is to investigate the efficacy of self-acupressure therapy on MEB associated with HBOT.
- Conditions
- Hyperbaric Oxygen Therapy, Middle Ear Barotrauma
- Being tested
- Self-acupressure therapy, Combined Valsalva and Toynbee maneuvers
- Keywords
- Hyperbaric oxygen therapy, Middle ear barotrauma, Acupressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-acupressure therapyProcedure or surgery
The self-acupressure therapy is as follows: Patients are in sitting position, applied firm pressure (3-5 kg of pressure) with the fingertips in a circular motion at a speed of two circles per second for a duration of one min per acupoint. A 1-2-s rest is applied after each ten circles. The complete process lasts for about 5 min.
Combined Valsalva and Toynbee maneuversProcedure or surgery
Valsalva maneuver: blowing against a closed mouth and nostrils, increasing the middle ear pressure. Toynbee maneuver: swallowing while the mouth and nostrils are closed, decreasing the middle ear pressure.
| Study group | Role | What they receive |
|---|---|---|
| Self-acupressure group | Experimental | The subjects in experimental group will undergo additional self-acupressure therapy in addition to Valsalva and Toynbee maneuvers before the first HBOT. The acupoints used are TE17 (Yifeng, 翳風), TE21 (Ermen, 耳門), SI19 (Tinggong, 聽宮), GB2 (Tinghui, 聽會). Receives: Procedure: Self-acupressure therapy; Procedure: Combined Valsalva and Toynbee maneuvers |
| Control group | Placebo comparator | The subjects in control group will receive Valsalva and Toynbee maneuvers alone. Receives: Procedure: Combined Valsalva and Toynbee maneuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Teed Classification
The Modified Teed Classification, with grades from 0 to 5: Grade 0 indicates symptoms with no ontological signs of trauma; Grade 1 indicates injection of the tympanic membrane; Grade 2 indicates Grade 1 plus injection plus mild hemorrhage within the tympanic membrane; Grade 3 indicates gross hemorrhage within the tympanic membrane; Grade 4 indicates free blood in the middle ear as evidenced by blueness and bulging; and Grade 5 indicates perforation of the tympanic membrane.
Measured: 1 month
Secondary outcomes (2)
Symptoms of MEB
Record the symptoms of MEB including feeling pressure in the ears, ear pain, headache, dizziness, vertigo, tinnitus and hearing loss. Each symptom is estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).
Measured: 1 month
Overall ear discomfort levels
Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Mar 2020
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperbaric Oxygen TherapyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a prospective nonrandomized controlled study. The participants will be assigned to two groups in a 1:1 ratio. The participants in the control group will receive conventional Valsalva and Toynbee maneuvers, while those in the experimental group will be given additional self-acupressure therapy.
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Ting Liu, MD, Principal investigator, Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311437
- Sponsor's protocol ID
- CMRPG8K0461
- Status last verified
- Jul 2021
- First submitted
- 16 Mar 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen JM, Lu ZN, Wu RW, Bi KW, Liu CT. Effect of self-acupressure on middle ear barotrauma associated with hyperbaric oxygen therapy: A nonrandomized clinical trial. Medicine (Baltimore). 2021 Apr 30;100(17):e25674. doi: 10.1097/MD.0000000000025674.
PubMed 33907136
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy: a Nonrandomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04311437
- Acronym / sponsor ID
- CMRPG8K0461
- Conditions
- Hyperbaric Oxygen Therapy, Middle Ear Barotrauma
- Keywords
- Hyperbaric oxygen therapy, Middle ear barotrauma, Acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 17 Mar 2020 (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.
Middle ear barotrauma (MEB) is the most common complication during hyperbaric oxygen therapy (HBOT). Though Valsalva and Toynbee maneuvers have been proposed to prevent MEB, still some patients discontinue HBOT due to severe otalgia, hemorrhage or perforation of tympanic membrane associated with HBOT. Currently, there is no optimal prophylactic management for MEB associated with HBOT. The aim of this protocol is to investigate the efficacy of self-acupressure therapy on MEB associated with HBOT.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective nonrandomized controlled study. The participants will be assigned to two groups in a 1:1 ratio. The participants in the control group will receive conventional Valsalva and Toynbee maneuvers, while those in the experimental group will be given additional self-acupressure therapy.
| Arm | Type | Receives |
|---|---|---|
| Self-acupressure group | Experimental | Procedure: Self-acupressure therapy, Procedure: Combined Valsalva and Toynbee maneuversThe subjects in experimental group will undergo additional self-acupressure therapy in addition to Valsalva and Toynbee maneuvers before the first HBOT. The acupoints used are TE17 (Yifeng, 翳風), TE21 (Ermen, 耳門), SI19 (Tinggong, 聽宮), GB2 (Tinghui, 聽會). |
| Control group | Placebo comparator | Procedure: Combined Valsalva and Toynbee maneuversThe subjects in control group will receive Valsalva and Toynbee maneuvers alone. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 20 years or order receiving the first HBOT
- Alert consciousness
Key exclusion criteria (5 listed)
- Pregnancy
- Having any acute disorder of the ears or upper respiratory tract
- Having evidence of neurologic dysfunction precluding them from making an informed decision
- Having a tracheostomy or endotracheal intubation
- Having received a myringotomy, tympanoplasty, mastoidectomy or tympanostomy tube placement.
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 |
|---|---|---|
| Self-acupressure therapyThe self-acupressure therapy is as follows: Patients are in sitting position, applied firm pressure (3-5 kg of pressure) with the fingertips in a circular motion at a speed of two circles per second for a duration of one min per acupoint. A 1-2-s rest is applied after each ten circles. The complete process lasts for about 5 min. | Procedure or surgery | Self-acupressure group |
| Combined Valsalva and Toynbee maneuversValsalva maneuver: blowing against a closed mouth and nostrils, increasing the middle ear pressure. Toynbee maneuver: swallowing while the mouth and nostrils are closed, decreasing the middle ear pressure. | Procedure or surgery | Control group, Self-acupressure group |
Primary outcome
Modified Teed Classification
Time frame: 1 month
The Modified Teed Classification, with grades from 0 to 5: Grade 0 indicates symptoms with no ontological signs of trauma; Grade 1 indicates injection of the tympanic membrane; Grade 2 indicates Grade 1 plus injection plus mild hemorrhage within the tympanic membrane; Grade 3 indicates gross hemorrhage within the tympanic membrane; Grade 4 indicates free blood in the middle ear as evidenced by blueness and bulging; and Grade 5 indicates perforation of the tympanic membrane.
2 secondary outcomes
Symptoms of MEB
Time frame: 1 month
Overall ear discomfort levels
Time frame: 1 month
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 20 Aug 2026.
- Derived from this study: PubMed 33907136Chen JM, Lu ZN, Wu RW, Bi KW, Liu CT. Effect of self-acupressure on middle ear barotrauma associated with hyperbaric oxygen therapy: A nonrandomized clinical trial. Medicine (Baltimore). 2021 Apr 30;100(17):e25674. doi: 10.1097/MD.0000000000025674.
- Individual participant dataSharing planned: No
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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.
Chun-Ting Liu, MD principal investigator
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial 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 Self-acupressure therapy and Combined Valsalva and Toynbee maneuvers in people with Hyperbaric Oxygen Therapy and Middle Ear Barotrauma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 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 20 Aug 2026. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Modified Teed Classification (time frame: 1 month). 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 NCT04311437, which also lists 1 linked publication.
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 20 Aug 2026.