Diaphragmatic Doming vs Breathing Exercises on Ventilatory Function & Core Endurance in Chronic Neck Pain

Not Applicable

Completed

• Conditions: Neck Pain
• Interventions: Other: Diaphragmatic Breathing Exercise; Other: Doming of the diaphragm; Other: Conventional exercise program for chronic neck pain; Other: Pursed Lip Breathing Exercise

• Registration Number: NCT06119399
• Lead Sponsor: Mina Atef Georgui Elias

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2023-10-28
• Study First Submitted QC: 2023-11-04
• Study First Posted: 2023-11-07
• Primary Completion: 2024-01-31
• Study Completion: 2024-05-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breathing Exercises Plus Conventional Exercise Program for Chronic Neck Pain	Diaphragmatic Breathing Exercise	Subjects will receive conventional exercise program for Chronic Neck Pain in addition to breathing exercises (diaphragmatic and pursed lip breathing) for (three sessions per week for six weeks).
Doming of the diaphragm plus Conventional Exercise Program for Chronic Neck Pain	Conventional exercise program for chronic neck pain	Patients in this arm will receive conventional physiotherapy treatment for Chronic Neck Pain in addition to doming of the diaphragm (three sessions per week for six weeks).
Breathing Exercises Plus Conventional Exercise Program for Chronic Neck Pain	Pursed Lip Breathing Exercise	Subjects will receive conventional exercise program for Chronic Neck Pain in addition to breathing exercises (diaphragmatic and pursed lip breathing) for (three sessions per week for six weeks).
Doming of the diaphragm plus Conventional Exercise Program for Chronic Neck Pain	Doming of the diaphragm	Patients in this arm will receive conventional physiotherapy treatment for Chronic Neck Pain in addition to doming of the diaphragm (three sessions per week for six weeks).
Breathing Exercises Plus Conventional Exercise Program for Chronic Neck Pain	Conventional exercise program for chronic neck pain	Subjects will receive conventional exercise program for Chronic Neck Pain in addition to breathing exercises (diaphragmatic and pursed lip breathing) for (three sessions per week for six weeks).

Primary Outcome Measures

Name	Time	Method
Endurance of deep cervical flexors	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	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)	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).	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)	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)	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)

Secondary Outcome Measures

Name	Time	Method
FEV1/FVC ratio	6 weeks	FEV1/FVC ratio is a calculated ratio of Forced expiratory volume in the first second (FEV1) to Forced vital capacity (FVC).; t represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).

Trial Locations

Locations (2)

Outpatient clinic, Faculty of physical therapy, Cairo University.; 🇪🇬 Giza, Dokki, Egypt

Outpatient Clinic; Faculty of Physical Therapy, Badr University in Cairo.; 🇪🇬 Cairo, Badr, Egypt