Respiration in Chronic Low Back Pain

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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Haliç University
    • Contact: Seda Saka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic low back pain patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Seda Saka

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Anticipated): April 20, 2023
• Study Completion (Anticipated): May 20, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Muscle strength; Respiratory function test; Respiratory muscles
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: nterzikoparan1

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