Neck PainNCT06119399
Diaphragmatic Doming vs Breathing Exercises on Ventilatory Function & Core Endurance in Chronic Neck Pain
A study testing Diaphragmatic Breathing Exercise, Pursed Lip Breathing Exercise and Doming of the diaphragm in people with Neck Pain, run by Mina Atef Georgui Elias at 2 sites in Egypt.
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 Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Diaphragmatic Breathing Exercise, Pursed Lip Breathing Exercise and Doming of the diaphragm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Outpatient Clinic; Faculty of Physical Therapy, Badr University in Cairo.
Cairo, Badr
Outpatient clinic, Faculty of physical therapy, Cairo University.
Giza, Dokki
About this study
Official title: Effect Of Diaphragmatic Doming Versus Breathing Exercises On Ventilatory Function And Core Endurance In Chronic Neck Pain Patients
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
- Conditions
- Neck Pain
- Being tested
- Diaphragmatic Breathing Exercise, Pursed Lip Breathing Exercise, Doming of the diaphragm, Conventional exercise program for chronic neck pain
- Keywords
- Chronic Neck Pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic Breathing ExerciseOther
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 ExerciseOther
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 diaphragmOther
- 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 painOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercises Plus Conventional Exercise Program for Chronic Neck Pain | Experimental | 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). Receives: Other: Diaphragmatic Breathing Exercise; Other: Pursed Lip Breathing Exercise; Other: Conventional exercise program for chronic neck pain |
| Doming of the diaphragm plus Conventional Exercise Program for Chronic Neck Pain | Experimental | 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). Receives: Other: Doming of the diaphragm; Other: Conventional exercise program for chronic neck pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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)
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Mar 2022
- Primary completion31 Jan 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mina Atef Georgui Elias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mina Atef Georgui Elias, Badr University
- Investigators
- 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119399
- Sponsor's protocol ID
- P.T.REC/012/003656
- Status last verified
- Aug 2024
- First submitted
- 28 Oct 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Diaphragmatic Doming Versus Breathing Exercises On Ventilatory Function And Core Endurance In Chronic Neck Pain Patients
- ClinicalTrials.gov ID
- NCT06119399
- Acronym / sponsor ID
- P.T.REC/012/003656
- Conditions
- Neck Pain
- Keywords
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mina Atef Georgui EliasUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercises Plus Conventional Exercise Program for Chronic Neck Pain | Experimental | Other: Diaphragmatic Breathing Exercise, Other: Pursed Lip Breathing Exercise, Other: Conventional exercise program for chronic neck painSubjects 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 | Experimental | Other: Doming of the diaphragm, Other: Conventional exercise program for chronic neck painPatients 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). |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic Breathing ExerciseDiaphragmatic 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) | Other | Breathing Exercises Plus Conventional Exercise Program for Chronic Neck Pain |
| Pursed Lip Breathing ExercisePursed 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 | Other | Breathing Exercises Plus Conventional Exercise Program for Chronic Neck Pain |
| 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. | Other | Doming of the diaphragm plus Conventional Exercise Program for Chronic Neck Pain |
| Conventional exercise program for chronic neck painPatients 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. | Other | Breathing Exercises Plus Conventional Exercise Program for Chronic Neck Pain, Doming of the diaphragm plus Conventional Exercise Program for Chronic Neck Pain |
Primary outcome
Endurance of deep cervical flexors
Time frame: 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).
Forced expiratory volume in the first second (FEV1)
Time frame: 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).
Time frame: 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.
Peak expiratory flow rate (PEFR)
Time frame: 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)
Neck Disability Index (NDI)
Time frame: 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.
Visual Analogue Score for pain intensity
Time frame: 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.
1 secondary outcome
FEV1/FVC ratio
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Breathing Exercise, Pursed Lip Breathing Exercise and Doming of the diaphragm in people with Neck Pain, run by Mina Atef Georgui Elias at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance of deep cervical flexors (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024; AzTrials last refreshed its copy on 29 Oct 2026.