Clinical trial NCT05718713: Respiration in Chronic Low Back Pain
Official title: Respiratory Muscle Strength and Respiratory Functions in Patients With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Low-back Pain
Keywords: Respiratory muscles
Respiratory function test
Muscle strength
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic low back pain patients

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: FEV1 (liter)
timeFrame: 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.
measure: FEV1 (%-percentage)
timeFrame: 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.
measure: FVC (liter)
timeFrame: 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.
measure: FVC (%-percentage)
timeFrame: 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.
measure: FEV1/FVC (percentage)
timeFrame: 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.
measure: Inspiratory muscle test
timeFrame: 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.
measure: Expiratory muscle test
timeFrame: 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.
measure: Star Excursion Balance Test (SEBT)
timeFrame: 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.
measure: Berg Balance Scale (BBS)
timeFrame: 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:
measure: Change in Visual Analog Scale (VAS) Pain Score
timeFrame: 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.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haliç University
city: Istanbul
country: Turkey
facility: Haliç University
Study officials:
name: Seda Saka
role: STUDY_DIRECTOR
affiliation: XXX Clinic
name: Abdullah Okur
role: PRINCIPAL_INVESTIGATOR
name: Nagihan Koparan
role: PRINCIPAL_INVESTIGATOR
name: Berna Calp
role: PRINCIPAL_INVESTIGATOR
References: