Central SensitisationNCT06485414
Investigating the Association Between Central Sensitization and Breathing Pattern Disorders
An observational study of Central Sensitisation, run by Sahmyook University at 1 site in South Korea.
Trial summary
Breathing pattern disorders can cause mechanical, physiological, and psychological issues in the body, contributing to the initiation and chronicity of pain. Therefore, considering breathing patterns is significant in managing chronic pain, yet direct research on central sensitization and breathing pattern disorders… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Sensitisation
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jul 2024to 31 Aug 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Participants were voluntarily recruited from church members who complained of symptoms of central sensitization and were registered according to the inclusion and exclusion criteria.
Who may be able to join
- Adults aged 18 and above.
- Individuals scoring 40 or above on the Central Sensitization Inventory for Koreans (CSI-K).
- Individuals who consent to the use and publication of their personal information and wish to participate in assessment measurements.
Who cannot join
- Individuals with pulmonary, cardiac, or respiratory diseases.
- Individuals with severe hypertension, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.
- Individuals with cognitive impairments.
- Individuals who express a desire to withdraw from the study during its duration.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Honam University
Gwangju, 62399
Hyeonmo Im, BSc, +82)1066855354, gwg04273@naver.com
About this study
Official title: Investigating the Association Between Central Sensitization and Breathing Pattern Disorders : A STROBE-compliant Cross-sectional Study
Breathing pattern disorders can cause mechanical, physiological, and psychological issues in the body, contributing to the initiation and chronicity of pain. Therefore, considering breathing patterns is significant in managing chronic pain, yet direct research on central sensitization and breathing pattern disorders remains scant. This study aims to analyze the correlation between central sensitization and breathing pattern disorders in adults by assessing both respiration and pain.
Read the detailed description
Breathing pattern disorders impact consciousness and the body according to respiratory patterns, leading to physiological, mechanical, and psychological disturbances. Unlike normal breathing patterns facilitated by appropriate diaphragmatic activity, incorrect patterns often exhibit reduced diaphragmatic engagement. Chest breathing patterns are prevalent among chronic pain patients, characterized by limited upper chest segment movement due to prolonged improper respiration without specific pathological symptoms. Fluoroscopy studies reveal flattened and tense diaphragms with diminished relative mobility, implicating accessory and inspiratory muscles more heavily in ventilation. Biologically unsustainable functional breathing patterns correlate with chronic musculoskeletal issues and pain. Prior research establishes associations between inappropriate breathing patterns and chronic lower back pain and scapular dysfunctions. Consequently, managing chronic pain clinically necessitates functional recovery and pain relief, crucial for sustaining daily life. Therefore, researching central adaptations and respiration in chronic pain management is imperative, yet remains insufficiently explored.
- Conditions
- Central Sensitisation
- Keywords
- central sensitization, breathing pattern disorders, chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| central sensitization | Individuals who scored above 40 on the Central Sensitization Inventory for Koreans (CSI-K) assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory function
This study utilized the Self Evaluation of Breathing Questionnaire (SEBQ) to assess respiratory function. The SEBQ is a self-administered questionnaire designed to measure symptoms and severity associated with respiratory dysfunction. It consists of 25 items, each rated on a 4-point scale (0 = not at all, to 3 = very much so), with a total possible score ranging from 0 to 75. While there is no definitive cutoff score for the SEBQ, experts consider a total score above 25 to indicate a problem with respiratory function. The SEBQ has a test-retest reliability (ICC) of 0.89 and internal consistency (Cronbach's α) of 0.93.
Measured: During the assessment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start3 Jul 2024 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central SensitisationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunjoong Kim, Sahmyook University
- Investigators
- Hyunjoong Kim, PhD, Principal investigator, Gwangju Health University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485414
- Sponsor's protocol ID
- 1014223-202405-HR-01
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Association Between Central Sensitization and Breathing Pattern Disorders : A STROBE-compliant Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06485414
- Acronym / sponsor ID
- 1014223-202405-HR-01
- Conditions
- Central Sensitisation
- Keywords
- central sensitization, breathing pattern disorders, chronic pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 3 Jul 2024 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
Breathing pattern disorders can cause mechanical, physiological, and psychological issues in the body, contributing to the initiation and chronicity of pain. Therefore, considering breathing patterns is significant in managing chronic pain, yet direct research on central sensitization and breathing pattern disorders remains scant. This study aims to analyze the correlation between central sensitization and breathing pattern disorders in adults by assessing both respiration and pain.
Detailed description
Breathing pattern disorders impact consciousness and the body according to respiratory patterns, leading to physiological, mechanical, and psychological disturbances. Unlike normal breathing patterns facilitated by appropriate diaphragmatic activity, incorrect patterns often exhibit reduced diaphragmatic engagement. Chest breathing patterns are prevalent among chronic pain patients, characterized by limited upper chest segment movement due to prolonged improper respiration without specific pathological symptoms. Fluoroscopy studies reveal flattened and tense diaphragms with diminished relative mobility, implicating accessory and inspiratory muscles more heavily in ventilation. Biologically unsustainable functional breathing patterns correlate with chronic musculoskeletal issues and pain. Prior research establishes associations between inappropriate breathing patterns and chronic lower back pain and scapular dysfunctions. Consequently, managing chronic pain clinically necessitates functional recovery and pain relief, crucial for sustaining daily life. Therefore, researching central adaptations and respiration in chronic pain management is imperative, yet remains insufficiently explored.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| central sensitization | – | –Individuals who scored above 40 on the Central Sensitization Inventory for Koreans (CSI-K) assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants were voluntarily recruited from church members who complained of symptoms of central sensitization and were registered according to the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Adults aged 18 and above.
- Individuals scoring 40 or above on the Central Sensitization Inventory for Koreans (CSI-K).
- Individuals who consent to the use and publication of their personal information and wish to participate in assessment measurements.
Key exclusion criteria (4 listed)
- Individuals with pulmonary, cardiac, or respiratory diseases.
- Individuals with severe hypertension, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.
- Individuals with cognitive impairments.
- Individuals who express a desire to withdraw from the study during its duration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory function
Time frame: During the assessment period
This study utilized the Self Evaluation of Breathing Questionnaire (SEBQ) to assess respiratory function. The SEBQ is a self-administered questionnaire designed to measure symptoms and severity associated with respiratory dysfunction. It consists of 25 items, each rated on a 4-point scale (0 = not at all, to 3 = very much so), with a total possible score ranging from 0 to 75. While there is no definitive cutoff score for the SEBQ, experts consider a total score above 25 to indicate a problem with respiratory function. The SEBQ has a test-retest reliability (ICC) of 0.89 and internal consistency (Cronbach's α) of 0.93.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Hyunjoong Kim, PhD principal investigator
Gwangju Health University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Sensitisation, run by Sahmyook University at 1 site in South Korea.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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 South Korea. 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?
Contact Hyeonmo Im, BSc (+82)1066855354, gwg04273@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory function (time frame: During the assessment period). 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 3 Jul 2024.