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CompletedNCT06119399Updated Aug 12, 2024

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

An interventional study of Diaphragmatic Breathing Exercise and Pursed Lip Breathing Exercise in Neck Pain, sponsored by Mina Atef Georgui Elias. Completed at 2 sites in Egypt. Open to participants aged 20 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by Mina Atef Georgui Elias · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Mar 2022, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 30 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Neck Pain

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Keywords

  • Chronic Neck Pain
03

In context

Neck Pain

1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.

This study's enrollment of 60 is above the median of 52 across 1,004 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Mina Atef Georgui Elias is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Breathing Exercises Plus 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).

    Other: Diaphragmatic Breathing Exercise · Other: Pursed Lip Breathing Exercise · Other: Conventional exercise program for chronic neck pain

  • Experimental
    Doming of the diaphragm plus 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).

    Other: Doming of the diaphragm · Other: Conventional exercise program for chronic neck pain

Interventions

  • OtherDiaphragmatic 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)

  • OtherPursed 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

  • OtherDoming 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.

  • OtherConventional 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 weeks

  2. 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.

    Time frame: 6 weeks

  3. 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.

    Time frame: 6 weeks

  4. 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)

    Time frame: 6 weeks

  5. 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.

    Time frame: 6 weeks

  6. 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.

    Time frame: 6 weeks

Secondary outcomes

  1. 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).

    Time frame: 6 weeks

07

Study locations

2 sites
  • Outpatient Clinic; Faculty of Physical Therapy, Badr University in Cairo.
    Cairo, Badr, Egypt
  • Outpatient clinic, Faculty of physical therapy, Cairo University.
    Giza, Dokki, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06119399
Lead sponsor
Mina Atef Georgui Elias
Responsible party
Mina Atef Georgui Elias (Lecturer of Internal Medicine and Geriatric, Faculty of Physical Therapy, Badr University in Cairo., Badr University) — Sponsor-investigator
First posted
Nov 7, 2023
Start date
Mar 1, 2022
Primary completion
Jan 31, 2024
Completion
May 31, 2024
Last update
Aug 12, 2024

Study contacts

Eman NE Sayed, M.Sc.
principal investigator · Assistant Lecturer, dept of internal medicine & geriatric, Badr University in Cairo.
Mina AG Elias, Dr.
study chair · Lecturer, dept of internal medicine & geriatric, Badr University in Cairo.
Hany E Obaya, Ass.Prof.Dr
study director · Dept of PT for Cardiovascular/Respiratory Disorder & Geriatrics, Faculty of PT, Cairo Univ.
Asmaa M Sharabash, Dr.
study chair · Dept of PT for Cardiovascular/Respiratory Disorder & Geriatric, Faculty of PT, Cairo Univ.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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