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临床试验/NCT05718713
NCT05718713招募中不适用

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

Seda Saka1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
1
主要终点
FVC (%-percentage)

研究概览

简要总结

The goal of this observational study is to learn about respiratory muscle strength, respiratory functions, and balance in patients with chronic low back pain.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

FVC (%-percentage)

时间窗: 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.

FVC (liter)

时间窗: 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.

Inspiratory muscle test

时间窗: 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).

Star Excursion Balance Test (SEBT)

时间窗: 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.

FEV1 (liter)

时间窗: 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)

时间窗: 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.

FEV1/FVC (percentage)

时间窗: 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.

Expiratory muscle test

时间窗: 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).

Berg Balance Scale (BBS)

时间窗: 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.

次要结局

  • Change in Visual Analog Scale (VAS) Pain Score(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.)

研究者

发起方
Seda Saka
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Seda Saka

Asst. Prof.

Halic University

研究点 (1)

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