Chronic Low-back PainNCT05718713
Respiration in Chronic Low Back Pain
An observational study of Chronic Low-back Pain, run by Seda Saka at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about respiratory muscle strength, respiratory functions, and balance in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- How many people
- 24 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Jan 2023to 20 May 2023
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic low back pain patients
Who may be able to join
- being diagnosed with chronic low back pain
- being age 25-65
- defining pain with a minimum of 5 out of 10 in Visual Analog Scale (VAS)
- getting at least 24 points from the Mini Mental Test.
Who cannot join
- Having physical therapy in the last one month
- Orthopedic, neurological, and vestibular problems that will affect balance
- Severe discopathy
- Compression fracture
- Pregnancy
- Body Mass Index (BMI) of > 30kg
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Haliç University
Istanbul
- Recruiting
Haliç University
Istanbul
Seda Saka
About this study
Official title: Respiratory Muscle Strength and Respiratory Functions in Patients With Chronic Low Back Pain
The goal of this observational study is to learn about respiratory muscle strength, respiratory functions, and balance in patients with chronic low back pain.
Read the detailed description
Coordination between the stabilizer muscles of the trunk and respiratory functions may be lacking in people with chronic low back pain. However, a specially designed study investigating the relationship between respiratory functions and balance parameters in individuals with chronic low back pain is lacking. The goal of this observational study is to learn about respiratory muscle strength, respiratory functions, and balance in patients with chronic low back pain. Twenty-four individuals with low back pain for at least 6 months are going to include in the study. Pain assessment is going to assess with a Visual Analogue Scale. Respiratory muscle strength is going to measure by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Pulmonary function assessment (PFT) is going to assess using a spirometer. Balance assessment is going to evaluate with Star Balance Test and Berg Balance Scale. Flexibility is going to evaluate with the Functional Reach Test.
- Conditions
- Chronic Low-back Pain
- Keywords
- Respiratory muscles, Respiratory function test, Muscle strength
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 (liter)
This is the amount of air with pulmonary function test that the patient can force out of their lungs in one second.
Measured: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
FEV1 (%-percentage)
This is the percentage of air with pulmonary function test that the patient can force out of their lungs in one second.
Measured: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
FVC (liter)
This is the greatest total amount of air patient can forcefully breathe out after breathing in as deeply as possible.
Measured: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
FVC (%-percentage)
This is the percentage of total amount of air patient can forcefully breathe out after breathing in as deeply as possible.
Measured: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
FEV1/FVC (percentage)
The FEV1/FVC ratio is a number that represents the percentage of patient lung capacity patient is able to exhale in one second.
Measured: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
Inspiratory muscle test
Maximal inspiratory pressure (MIP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
Measured: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
Expiratory muscle test
Maximal expiratory pressure (MEP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
Measured: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
Star Excursion Balance Test (SEBT)
Four strips of athletic tape will need to be cut to a length of 6-8 feet each. Two pieces will be used to form a '+', with the other two being placed over top to form an 'x' so that a star shape is formed. It is important that all lines are separated from each other by a 45° angle. The goal of the SEBT is to maintain single leg stance on one leg while reaching as far as possible with the contralateral leg.
The person performing the test must maintain a their balance on one leg, while using the other leg to reach as far as possible in 8 different directions. The person (standing on his/her left leg for example) must reach in 8 different positions, once in each of the following directions: anterior, anteromedial, medial, posteromedial, posterior, posterolateral, lateral and anterolateral.
Measured: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Measured: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
Secondary outcomes (1)
Change in Visual Analog Scale (VAS) Pain Score
The VAS is a widely used scale for pain assessment in daily practice. VAS, with 0-10 numbers on it and they are asked to give a value between these numbers. 0: I have no pain, 10: I have very severe pain
Measured: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start30 Jan 2023
- Primary completion20 Apr 2023 (estimated)
- Study completion20 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies 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
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seda Saka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seda Saka, Halic University
- Investigators
- Seda Saka, Study directorAbdullah Okur, Principal investigator, XXX ClinicNagihan Koparan, Principal investigatorBerna Calp, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718713
- Sponsor's protocol ID
- nterzikoparan1
- Status last verified
- Apr 2023
- First submitted
- 30 Jan 2023
- Last updated
- 5 Apr 2023
- 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 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Strength and Respiratory Functions in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05718713
- Acronym / sponsor ID
- nterzikoparan1
- Conditions
- Chronic Low-back Pain
- Keywords
- Respiratory muscles, Respiratory function test, Muscle strength
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Seda SakaUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 20 Apr 2023 (estimated)
- Study completion
- 20 May 2023 (estimated)
- First posted
- 8 Feb 2023 (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.
The goal of this observational study is to learn about respiratory muscle strength, respiratory functions, and balance in patients with chronic low back pain.
Detailed description
Coordination between the stabilizer muscles of the trunk and respiratory functions may be lacking in people with chronic low back pain. However, a specially designed study investigating the relationship between respiratory functions and balance parameters in individuals with chronic low back pain is lacking. The goal of this observational study is to learn about respiratory muscle strength, respiratory functions, and balance in patients with chronic low back pain. Twenty-four individuals with low back pain for at least 6 months are going to include in the study. Pain assessment is going to assess with a Visual Analogue Scale. Respiratory muscle strength is going to measure by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Pulmonary function assessment (PFT) is going to assess using a spirometer. Balance assessment is going to evaluate with Star Balance Test and Berg Balance Scale. Flexibility is going to evaluate with the Functional Reach Test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic low back pain patients
Key inclusion criteria (4 listed)
- being diagnosed with chronic low back pain
- being age 25-65
- defining pain with a minimum of 5 out of 10 in Visual Analog Scale (VAS)
- getting at least 24 points from the Mini Mental Test.
Key exclusion criteria (6 listed)
- Having physical therapy in the last one month
- Orthopedic, neurological, and vestibular problems that will affect balance
- Severe discopathy
- Compression fracture
- Pregnancy
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
FEV1 (liter)
Time frame: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
This is the amount of air with pulmonary function test that the patient can force out of their lungs in one second.
FEV1 (%-percentage)
Time frame: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
This is the percentage of air with pulmonary function test that the patient can force out of their lungs in one second.
FVC (liter)
Time frame: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
This is the greatest total amount of air patient can forcefully breathe out after breathing in as deeply as possible.
FVC (%-percentage)
Time frame: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
This is the percentage of total amount of air patient can forcefully breathe out after breathing in as deeply as possible.
FEV1/FVC (percentage)
Time frame: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
The FEV1/FVC ratio is a number that represents the percentage of patient lung capacity patient is able to exhale in one second.
Inspiratory muscle test
Time frame: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
Maximal inspiratory pressure (MIP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
Expiratory muscle test
Time frame: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
Maximal expiratory pressure (MEP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
Star Excursion Balance Test (SEBT)
Time frame: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
Four strips of athletic tape will need to be cut to a length of 6-8 feet each. Two pieces will be used to form a '+', with the other two being placed over top to form an 'x' so that a star shape is formed. It is important that all lines are separated from each other by a 45° angle. The goal of the SEBT is to maintain single leg stance on one leg while reaching as far as possible with the contralateral leg. The person performing the test must maintain a their balance on one leg, while using the other leg to reach as far as possible in 8 different directions. The person (standing on his/her left leg for example) must reach in 8 different positions, once in each of the following directions: anterior, anteromedial, medial, posteromedial, posterior, posterolateral, lateral and anterolateral.
Berg Balance Scale (BBS)
Time frame: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
1 secondary outcome
Change in Visual Analog Scale (VAS) Pain Score
Time frame: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- 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.
Seda Saka study director
Abdullah Okur principal investigator
XXX Clinic
Nagihan Koparan principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain, run by Seda Saka at 2 sites in Turkey (Türkiye).
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 4 inclusion and 6 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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 Abdullah Okur (+90 5349573147, fzt.abdullahokur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 (liter) (time frame: During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.). The study lists 9 primary outcomes in all. 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 5 Apr 2023.