- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06485414
Investigating the Association Between Central Sensitization and Breathing Pattern Disorders
June 29, 2024 updated by: Hyunjoong Kim, Sahmyook University
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.
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hyeonmo Im, BSc
- Phone Number: +82)1066855354
- Email: gwg04273@naver.com
Study Locations
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Gwangju, Korea, Republic of, 62399
- Honam University
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Contact:
- Hyeonmo Im, BSc
- Phone Number: +82)1066855354
- Email: gwg04273@naver.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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central sensitization
Individuals who scored above 40 on the Central Sensitization Inventory for Koreans (CSI-K) assessment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Respiratory function
Time Frame: During the assessment period
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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.
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During the assessment period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hyunjoong Kim, PhD, Gwangju Health University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 3, 2024
Primary Completion (Estimated)
July 31, 2024
Study Completion (Estimated)
August 31, 2024
Study Registration Dates
First Submitted
June 25, 2024
First Submitted That Met QC Criteria
June 29, 2024
First Posted (Actual)
July 3, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
June 29, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1014223-202405-HR-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.