- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05712239
Effect of Lumber Core Stability Exercises on Chronic Non-specific Neck Pain
Effect of Adding Lumbar Core Stability Exercises to Cervical and Scapular Stabilization Exercises and Advices on Chronic Non- Specific Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hend W Mostafa, MSc
- Phone Number: 00201004225661
- Email: hendwageh.95@gmail.com
Study Locations
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-
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Giza, Egypt
- Recruiting
- Faculty of physical therapy, Cairo University
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Contact:
- Hend W Mostafa, MSc
- Phone Number: 00201004225661
- Email: hendwageh.95@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with persistent cervical pain for more than 12 weeks without specific diagnosis (chronic non-specific neck pain).
- BMI less than 30 kg/m2.
- Pain intensity on VAS should be more than 3.
- Patient will be able and motivated in completing the study.
- Psychologically & mentally stable.
Exclusion Criteria:
- Red Flag's symptoms including a history of major trauma, persistent night pain, bladder or bowel dysfunction, and/or lower or upper extremity neurological deficit.
- Pregnant women.
- Recent or old fractures at spine or upper limbs.
- Congenital, or acquired postural deformity.
- No previous neck or spinal or shoulder surgery.
- No current pathologies (e.g. Disc lesion, nerve root compression, canal stenosis, spinal tumor, spinal infection, systemic inflammatory diseases, …).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Advices Group
Patients in this group will take only advices about their postures and activities of daily living
|
The advices will include patient's reassurance and description of possible causes of neck pain such as poor working ergonomics, common bad postures especially while using electronic devices for long periods and not adjustable sleeping pillows.
Also, patient will be educated how to modify these different causes and asked to apply gentle neck range of motion exercises
|
|
Active Comparator: Cervical and scapular stabilization Group
Patients in this group will take advices and stability exercises for neck and scapula
|
The advices will include patient's reassurance and description of possible causes of neck pain such as poor working ergonomics, common bad postures especially while using electronic devices for long periods and not adjustable sleeping pillows.
Also, patient will be educated how to modify these different causes and asked to apply gentle neck range of motion exercises
Deep neck flexor training will be performed in neurodevelopment stages (supine at first week using pressure biofeedback unit , prone at second week, quadrupedal at third week, bipedal at fourth week). Scapular stabilization exercises will include modified prone cobra, trapezius muscle exercise progression (3 stages), wall press and extension of the thoracic spine using foam roller. The modified prone cobra and the first stage of trapezius muscle exercise progression will be applied during the first two weeks. The second and third stages of trapezius muscle exercise will be applied during the last two weeks of our rehabilitation program. All exercises will be applied for 10 repetitions with 6-10 sec hold for 3 sets with 20 sec rest between each set. While wall press and thoracic extension exercises will be applied throughout the 4 weeks for 3 sets of 10 repetitions with 20 sec rest between each set. |
|
Experimental: Neck, scapular and lumber stabilization Group
Patients in this group will take advices, and stability exercises for neck, scapula and lumber spine
|
The advices will include patient's reassurance and description of possible causes of neck pain such as poor working ergonomics, common bad postures especially while using electronic devices for long periods and not adjustable sleeping pillows.
Also, patient will be educated how to modify these different causes and asked to apply gentle neck range of motion exercises
Deep neck flexor training will be performed in neurodevelopment stages (supine at first week using pressure biofeedback unit , prone at second week, quadrupedal at third week, bipedal at fourth week). Scapular stabilization exercises will include modified prone cobra, trapezius muscle exercise progression (3 stages), wall press and extension of the thoracic spine using foam roller. The modified prone cobra and the first stage of trapezius muscle exercise progression will be applied during the first two weeks. The second and third stages of trapezius muscle exercise will be applied during the last two weeks of our rehabilitation program. All exercises will be applied for 10 repetitions with 6-10 sec hold for 3 sets with 20 sec rest between each set. While wall press and thoracic extension exercises will be applied throughout the 4 weeks for 3 sets of 10 repetitions with 20 sec rest between each set. The program will be performed in three stages: activation, dynamic stabilization, and advanced core strengthening stages. Each stage will be applied for 4 sessions. The activation stage will be based on the learning to activate transversus abdominis muscle from crock lying position using pressure biofeedback unit. In the dynamic stabilization stage, the patient will be instructed to slowly raise both arms in the scapular plan then return to the sides while maintaining the transversus abdominis muscle activation. Also, the patient will apply bridging exercise in this stage. The advanced core strengthening stage will include prone plank and side plank (right and left sides). All the exercises will be applied for 10 repetitions with 6-10 sec hold for 3 sets. The rest of 20 sec will be taken between each set. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in pain intensity
Time Frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
|
Pain intensity will be assessed by using Visual analogue scale (VAS).
It is horizontal line with 10 cm length, with Zero marked at one end representing no pain and 10 marked at the other end representing worst imaginable pain.
|
This outcome will be assessed at the first day and after 4 weeks following end of treatment
|
|
change in functional disability
Time Frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
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Functional disability will be assessed using Arabic version of neck disability index.
The patients will be asked to make a mark in each section which most closely described their problem.
Each section consists of six potential responses for each item ranging from no disability (0) to total disability (5).
Thus, The NDI score ranges between 0-100, with higher scores indicating greater perceived disability.
The score of less than 4 indicates no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, and scores greater than 35 complete disabilities.
|
This outcome will be assessed at the first day and after 4 weeks following end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in Craniovertebral angle degree (CVA)
Time Frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
|
To measure CVA, the patient will be captured from the left side after putting landmarks on seventh cervical vertebra (c7) and tragus of the ear.
The photograph will be taken and analyzed with kinovea software by drawing a horizontal line passing through C7 and line connecting between the tragus of the ear and C7 and measuring the angle between these lines.
As the value of CVA decreases, the degree of FHP increases
|
This outcome will be assessed at the first day and after 4 weeks following end of treatment
|
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change of of deep neck flexor muscles (DNF) activation
Time Frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
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DNF activation will be assessed by Craniocervical flexion test using Pressure biofeedback unit
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This outcome will be assessed at the first day and after 4 weeks following end of treatment
|
|
change of deep neck flexor (DNF) endurance
Time Frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
|
DNF endurance will be assessed by Neck flexor endurance test
|
This outcome will be assessed at the first day and after 4 weeks following end of treatment
|
|
change of trunk flexor muscle endurance
Time Frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
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Trunk flexor muscle endurance will be assessed by Trunk flexion test (McGill's test)
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This outcome will be assessed at the first day and after 4 weeks following end of treatment
|
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change of trunk extensor muscle endurance
Time Frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
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Trunk extensor muscle endurance will be assessed by Trunk extension test (Sorenson Test)
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This outcome will be assessed at the first day and after 4 weeks following end of treatment
|
|
change of lateral trunk muscle endurance
Time Frame: This outcome will be assessed at the first day and after 4 weeks following end of treatment
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Lateral trunk muscle endurance will be assessed Side plank test for left and right sides
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This outcome will be assessed at the first day and after 4 weeks following end of treatment
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003950
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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