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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119399
• Other study ID #: P.T.REC/012/003656
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: Badr University
• Contact: Mina AG Elias, Dr.
• Phone: +201227227266
• Email: mina.elias[@]buc.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Diaphragmatic Breathing Exercise
Diaphragmatic breathing exercise will be taught by placing the subject comfortably positioned with either therapist or the patient's hand directed over the abdominal area and instructing the subjects to focus on an outward movement of the abdominal area throughout inspiration and an inward movement of the abdominal area during expiration. (4 sets, and as each set had 4 complete breathing breaks, these exercises will be conducted for 3 days a week for 6 weeks)
• Pursed Lip Breathing Exercise
Pursed lip breathing exercises will be performed by necessitating the subjects to inhale through their nose and then exhaling slowly for a period of 4-6 s by pursing the lips
• Doming of the diaphragm
The physiotherapist places the thumbs just inferior to the patient's lower costal margin and xiphoid process with the thumbs pointing cephalad. The patient is instructed to take a deep breath and exhale. On exhalation, the physiotherapist's thumbs follow the diaphragm, which permits the thumbs to move posteriorly. The patient is instructed to inhale, and the physiotherapist gently resists this motion. The patient is instructed to exhale, and the physiotherapist gently follows this motion posteriorly and cephalad, as the thumbs are now beneath the costal margin and xiphoid process. The patient inhales as the physiotherapist maintains pressure on the upper abdomen and then, on repeated exhalation, encourages further cephalad excursion. This procedure is repeated for three to five respiratory cycles until the diaphragm domes easily at the end of exhalation.
• Conventional exercise program for chronic neck pain
Patients will perform three repetitions of stretching exercises for neck flexor, extensor, lateral flexor, and rotator for 30 seconds as warm-up and cool-down exercises, to relieve tension on each side of the neck. Then cranio-cervical flexion exercise will be started using feedback from an air-filled pressure sensor placed behind the neck. Subjects will lay in the crook lying position. The pressure biofeedback unit will be placed below the occiput and inflated up to a baseline pressure of 20 mmHg. The subjects will be instructed to perform head-nodding action to progressively target 5 pressure levels (hold 10 seconds with brief rest periods between each contraction 3-5 seconds). This includes 3 sets in a session for 10 repetitions each with 2 minutes of rest between sets and 3days a week for 6 weeks.

Locations

Country	Name	City	State
Egypt	Outpatient Clinic; Faculty of Physical Therapy, Badr University in Cairo.	Cairo	Badr
Egypt	Outpatient clinic, Faculty of physical therapy, Cairo University.	Giza	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Mina Atef Georgui Elias

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endurance of deep cervical flexors	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).	6 weeks
Primary	Forced expiratory volume in the first second (FEV1)	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.	6 weeks
Primary	Forced vital capacity (FVC).	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.	6 weeks
Primary	Peak expiratory flow rate (PEFR)	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)	6 weeks
Primary	Neck Disability Index (NDI)	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.	6 weeks
Primary	Visual Analogue Score for pain intensity	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.	6 weeks
Secondary	FEV1/FVC ratio	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).	6 weeks