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临床试验/NCT06119399
NCT06119399已完成不适用

Effect Of Diaphragmatic Doming Versus Breathing Exercises On Ventilatory Function And Core Endurance In Chronic Neck Pain Patients

Mina Atef Georgui Elias2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Endurance of deep cervical flexors

研究概览

简要总结

The purpose of the study is to investigate if there is any difference between effect of diaphragmatic doming versus breathing exercises on ventilatory function and core endurance in patients with chronic neck pain

详细描述

Patients with chronic neck pain will be participated in this comparative study.

They will be divided into 2 groups:

Group (A) will be consisted of 30 patients who will receive conventional physiotherapy treatment for chronic neck pain plus breathing exercise (diaphragmatic and pursed lip breathing) (Three sessions per week for 6 weeks) Group (B) will be consisted of 30 patients who will receive conventional physiotherapy treatment for chronic neck pain plus Doming of the diaphragm (Three sessions per week for 6 weeks)

Pulmonary functions and neck endurance will be assessed for all patients in both groups before the first session and after the last session

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient has chronic neck pain (for more than 3 months)
  • Their age ranged from 20 to 30 years old
  • Their body mass index ranged from (18.5 -29.9) kg/m2
  • Poor results on the cranio-cervical flexion (CCF) test using a pressure biofeedback instrument.

排除标准

  • History of respiratory disease and Clinical signs of a severe cardiac event.
  • Severe psychiatric or cognitive impairment
  • Tumor and Spinal fractures
  • Spinal cord compression that required urgent surgery
  • Current or past Smokers
  • Obese (BMI >30) or underweight (BMI ˂18.5)

结局指标

主要结局

Endurance of deep cervical flexors

时间窗: 6 weeks

Endurance of deep cervical flexors muscles will be measured by the cranio-cervical flexion test using a pressure biofeedback instrument. During the cranio-cervical flexion test, the subject lay in the crook lying position and the pressure biofeedback instrument will be placed under the neutral cervical spine below the occiput and inflated up to 20 mmHg. The subjects will perform this movement at 5 different pressure levels, i.e., 22, 24, 26, 28, and 30 mmHg. Each level will be supposed to be held for 10 s, and the test will be terminated if they were unable to hold the position for 10 s at any level or if the maximum level was achieved (30 mmHg).

Visual Analogue Score for pain intensity

时间窗: 6 weeks

Visual Analogue score is a measure of pain severity, it is assessed by the self-reported Visual Analogue Scale (VAS). The Visual Analogue Scale evaluates the intensity of pain. It consists of a 10 cm line, that has two end points, where 0 represents "no pain at all" while 10 indicates "most severe pain". Every patient is asked to rate his/her level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain' (or zero) to the current pain mark. This provides pain intensity score out of 10.

Forced expiratory volume in the first second (FEV1)

时间窗: 6 weeks

Forced expiratory volume in the first second (FEV1) is one of ventilatory function test parameters, measured using Spirometry, Model SpirOx plus (by Meditech company-China) The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.

Forced vital capacity (FVC).

时间窗: 6 weeks

Forced vital capacity (FVC) is one of pulmonary function test parameters, measured using Spirometry, Model SpirOx plus (by Meditech company-China) Forced vital capacity (FVC) is the volume of air that can forcefully expired from the lungs following maximum inspiration, it is measured in liters.

Neck Disability Index (NDI)

时间窗: 6 weeks

Neck function is assessed using the self-reported Neck Disability Index (NDI), which is a valid and reliable test for measuring neck disability. The NDI consists of 10 items referring to daily activities (work, lifting, driving, sleeping, reading, headaches, recreation, concentration, personal care, and pain intensity). Each item (ranging from 0 to 5, with a score of 0 for no pain and no limitation and a score of 5 for maximum pain and limitation). The total maximum score is 50.

Peak expiratory flow rate (PEFR)

时间窗: 6 weeks

Peak expiratory flow rate (PEFR) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration, measured in liters per second. Peak expiratory flow rate (PEFR) as a pulmonary function, is measured using Spirometry, Model SpirOx plus (by Meditech company-China)

次要结局

  • FEV1/FVC ratio(6 weeks)

研究者

发起方
Mina Atef Georgui Elias
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mina Atef Georgui Elias

Lecturer of Internal Medicine and Geriatric, Faculty of Physical Therapy, Badr University in Cairo.

Badr University

研究点 (2)

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