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

NCT ID: NCT06119399

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-05-31

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

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Diaphragmatic Breathing Exercise

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Conventional exercise program for chronic neck pain

Intervention Type: OTHER

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.

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).

Group Type: EXPERIMENTAL

Doming of the diaphragm

Intervention Type: OTHER

• 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

Intervention Type: OTHER

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.

Interventions

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)

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mina Atef Georgui Elias

OTHER

Sponsor Role: lead

Responsible Party

Mina Atef Georgui Elias

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eman NE Sayed, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Assistant Lecturer, dept of internal medicine & geriatric, Badr University in Cairo.

Mina AG Elias, Dr.

Role: STUDY_CHAIR

Lecturer, dept of internal medicine & geriatric, Badr University in Cairo.

Hany E Obaya, Ass.Prof.Dr

Role: STUDY_DIRECTOR

Dept of PT for Cardiovascular/Respiratory Disorder & Geriatrics, Faculty of PT, Cairo Univ.

Asmaa M Sharabash, Dr.

Role: STUDY_CHAIR

Dept of PT for Cardiovascular/Respiratory Disorder & Geriatric, Faculty of PT, Cairo Univ.

Locations

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

Cairo, Badr, Egypt

Outpatient clinic, Faculty of physical therapy, Cairo University.

Giza, Dokki, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/003656

Identifier Type: -

Identifier Source: org_study_id