- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07531537
Respiratory Exercises Versus Deep Neck Flexor Training in Chronic Mechanical Neck Pain
Effect of Respiratory Muscle Exercises Versus Deep Neck Flexor Training on Pain, Function and Neck Muscle Endurance in Patients With Chronic Mechanical Neck Pain
This study will be conducted to compare the effect of adding respiratory exercises versus deep neck flexor training to conventional program on pain, cervical ROM, cervical muscle endurance, function, and chest expansion in patients with chronic mechanical neck pain. Sixty-six (66) of both genders ranging in age from 18 to 35 years old, with a history of mechanical neck pain longer than 3 months (chronic neck pain) will be invited to participate in this study. Participants will be randomly assigned into one of the three experimental groups as follow:
Group A will receive respiratory exercises in form of diaphragmatic breathing & respiratory muscle stretch gymnastics plus conventional program.
Group B will receive deep neck flexor training in the form of low-load craniocervical flexion using feedback from an air-filled pressure sensor placed behind the neck plus conventional program.
Group C (control group) will receive conventional program in form of TENS, infrared, isometric neck strengthening exercises and stretching exercises.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction:
Neck pain (NP) impacts the cervical motor system, posture, and movement. Motor output of cervical muscles is impaired. Muscles have decreased strength, endurance, and force steadiness and cervical muscle behavior is altered eg., decreased activity of deep postural muscles, reduced directional specificity, delayed onset of muscle responses and muscle fatigability. Patients with neck pain usually present with weak deep neck flexors and extensors, increased fatigability of superficial neck flexors, alterations in posture, limited range of motion, decreased proprioception and other psycho-social affections such as anxiety, depression, kinesiophobia, and catastrophizing. These factors are responsible for the predisposition of respiratory dysfunction in these patients.
Statement of the problem:
This study will be conducted to answer the following question: Does adding respiratory exercises or deep neck flexor training to conventional program have any effect on pain, ROM, cervical muscle endurance, function, and chest expansion?
Significance of the study:
The Global Burden of Disease Study stated that neck pain is globally the fourth largest physical complaint in years lived with a disability. The clinical practice guidelines recommended for patients with CNP interventions are: education, cervical mobilization and manipulation, thoracic manipulation, and mixed exercises for cervical and scapulothoracic regions, or an association of different interventions. Despite the high prevalence and significant impact of chronic neck pain, the optimal exercise-based intervention remains unclear. While previous research has investigated the benefits of conventional physical therapy, there is no study to date comparing the effect of respiratory exercises versus deep neck flexor training while adding to conventional program in the management of chronic neck pain patients. Therefore the current study will be conducted to compare the effectiveness of adding respiratory exercises versus deep neck flexor training to conventional program in patients with chronic neck pain.
Delimitations:
This study will be delimited to:
- Sixty-six patients of both genders, ranging in age from 18 to 35 years old, with a history of neck pain longer than 3 months (chronic neck pain).
- There will be three groups of twenty-two patients for each group; Group (A) will receive respiratory exercises in the form of diaphragmatic breathing & respiratory muscle stretch gymnastics plus conventional program in form of TENS, infrared, isometric strengthening and stretching exercises, Group (B) who will receive deep neck flexor training in form of low load craniocervical flexion using feedback from an air-filled pressure sensor placed behind the neck plus conventional program in form of TENS, infrared, isometric strengthening and stretching exercises & Group (C) who will receive combination of respiratory exercises and deep neck flexor training plus conventional program in form of TENS, infrared, isometric strengthening and stretching exercises for two times per week for 8 weeks.
- Neck pain will be measured by a visual analogue scale (VAS).
- The ACROM will be measured using a cervical range of motion device.
- Deep neck flexor endurance of cervical flexion will be assessed with the cranio-cervical flexion test using feedback from an air-filled pressure sensor.
- Neck function will be assessed with Arabic version of Neck Disability Index (NDI).
- Chest expansion will be assessed with measuring tape.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ola ismail ibrahim, M.Sc.
- Phone Number: +201008283364
- Email: olaismailibrahim@gmail.com
Study Contact Backup
- Name: karima abdelaty hassan, Ass. Prof.
- Phone Number: +201114032967
- Email: karima.abdelaty@pt.cu.edu.eg
Study Locations
-
-
-
Zagazig, Egypt
- Recruiting
- Taheel center for physiotherapy
-
Contact:
- ola ismail ibrahim, M.Sc.
- Phone Number: +201008283364
- Email: olaismailibrahim@gmail.com
-
Contact:
- karima abdelaty hassan, Ass.Prof.
- Phone Number: +201114032967
- Email: karima.abelaty@pt.cu.edu.eg
-
Principal Investigator:
- ola ismail ibrahim, M.Sc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients have mechanical neck pain lasting longer than three months.
- The ages of patients range from 18 to 35 years.
- Patients are lifetime non-smoker and non-alcoholic.
Exclusion Criteria:
- History of trauma or cervical spine fractures.
- Previous spinal surgery.
- Any inflammatory pathology.
- Any cervical disc pathology and neurological signs.
- Malignancy.
- Cervical radiculopathy.
- Rheumatoid arthritis.
- Pregnant female.
- Currently using muscle relaxation medication.
- History of respiratory and cardiovascular illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Respiratory exercises group
22 male and female patients with chronic mechanical neck pain who will receive respiratory exercises in form of diaphragmatic breathing & respiratory muscle stretch gymnastics plus conventional program.
|
respiratory exercises in form of diaphragmatic breathing & respiratory muscle stretch gymnastics plus conventional program
|
|
Experimental: Deep neck flexor training group
22 male and female patients with chronic mechanical neck pain who will receive deep neck flexor training in the form of low-load craniocervical flexion using feedback from an air-filled pressure sensor placed behind the neck plus conventional program
|
deep neck flexor training in the form of low-load craniocervical flexion using feedback from an air-filled pressure sensor placed behind the neck plus conventional program
|
|
Experimental: control group
22 male and female patients with chronic mechanical neck pain who will receive conventional program in form of TENS, infrared, isometric neck strengthening exercises and stretching exercises
|
conventional program in form of TENS, infrared, isometric neck strengthening exercises and stretching exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck pain
Time Frame: From enrollment to the end of treatment at 8 weeks
|
pain will be assessed by visual analogue scale
|
From enrollment to the end of treatment at 8 weeks
|
|
Cervical ROM
Time Frame: From enrollment to the end of treatment at 8 weeks
|
cervical ROM will be assessed by CROM device
|
From enrollment to the end of treatment at 8 weeks
|
|
Neck muscle endurance
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Neck muscle endurance will be assessed by crainiocervical flexion test using feedback from pressure sensor
|
From enrollment to the end of treatment at 8 weeks
|
|
Chest expansion
Time Frame: From enrollment to the end of treatment at 8 weeks
|
chest expansion will be assessed by taping measurement
|
From enrollment to the end of treatment at 8 weeks
|
|
Neck function
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Neck function will be assessed by neck disability index, Arabic version
|
From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: karima abdelaty hassan, Ass. Prof., Cairo university
- Study Director: dina sayed abdullah, lecturer, Cairo university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Chronic mechanical neck pain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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