Respiration in Chronic Low Back Pain

Chronic Low-back Pain Clinical Trial

Official title:

Respiratory Muscle Strength and Respiratory Functions in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718713
• Other study ID #: nterzikoparan1
• Status: Recruiting
• Start date: January 30, 2023
• Est. completion date: May 20, 2023

Study information

• Verified date: April 2023
• Source: Halic University
• Contact: Abdullah Okur
• Phone: +90 5349573147
• Email: fzt.abdullahokur[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Locations

Country	Name	City	State
Turkey	Haliç University	Istanbul
Turkey	Haliç University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Seda Saka

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 (liter)	This is the amount of air with pulmonary function test that the patient can force out of their lungs in one second.	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.
Primary	FEV1 (%-percentage)	This is the percentage of air with pulmonary function test that the patient can force out of their lungs in one second.	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.
Primary	FVC (liter)	This is the greatest total amount of air patient can forcefully breathe out after breathing in as deeply as possible.	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.
Primary	FVC (%-percentage)	This is the percentage of total amount of air patient can forcefully breathe out after breathing in as deeply as possible.	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.
Primary	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.	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.
Primary	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).	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.
Primary	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).	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.
Primary	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.	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.
Primary	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.	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	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	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.