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Effect of Lumber Core Stability Exercises on Chronic Non-specific Neck Pain

Primary Purpose

Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Advices
Cervical and Scapular Stabilization Exercises
Lumber Core Stability Program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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, …).

Sites / Locations

  • Faculty of Physical Therapy, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Experimental

Arm Label

Advices Group

Cervical and scapular stabilization Group

Neck, scapular and lumber stabilization Group

Arm Description

Patients in this group will take only advices about their postures and activities of daily living

Patients in this group will take advices and stability exercises for neck and scapula

Patients in this group will take advices, and stability exercises for neck, scapula and lumber spine

Outcomes

Primary Outcome Measures

change in pain intensity
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.
change in functional disability
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.

Secondary Outcome Measures

change in Craniovertebral angle degree (CVA)
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
change of of deep neck flexor muscles (DNF) activation
DNF activation will be assessed by Craniocervical flexion test using Pressure biofeedback unit
change of deep neck flexor (DNF) endurance
DNF endurance will be assessed by Neck flexor endurance test
change of trunk flexor muscle endurance
Trunk flexor muscle endurance will be assessed by Trunk flexion test (McGill's test)
change of trunk extensor muscle endurance
Trunk extensor muscle endurance will be assessed by Trunk extension test (Sorenson Test)
change of lateral trunk muscle endurance
Lateral trunk muscle endurance will be assessed Side plank test for left and right sides

Full Information

First Posted
January 26, 2023
Last Updated
August 30, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05712239
Brief Title
Effect of Lumber Core Stability Exercises on Chronic Non-specific Neck Pain
Official Title
Effect of Adding Lumbar Core Stability Exercises to Cervical and Scapular Stabilization Exercises and Advices on Chronic Non- Specific Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Chronic non-specific neck pain patients will be enrolled in 3 groups in this study including passive, active control and experimental groups to determine the effect of adding lumbar core stability exercises to patient's advices and cervical and scapular stabilization exercises. For the last two groups, the sessions will be applied 3 times per week for 4 weeks. All the outcomes will be measured after patient's enrollment and at the end of 4 weeks to determine the difference between groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
To confirm blindness, all patients will be unaware of the group allocation and the exercises performed by the other group. Also, the pictures of craniovertebral angle will be coded before being measured
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advices Group
Arm Type
Other
Arm Description
Patients in this group will take only advices about their postures and activities of daily living
Arm Title
Cervical and scapular stabilization Group
Arm Type
Active Comparator
Arm Description
Patients in this group will take advices and stability exercises for neck and scapula
Arm Title
Neck, scapular and lumber stabilization Group
Arm Type
Experimental
Arm Description
Patients in this group will take advices, and stability exercises for neck, scapula and lumber spine
Intervention Type
Other
Intervention Name(s)
Advices
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Cervical and Scapular Stabilization Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Lumber Core Stability Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in pain intensity
Description
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.
Time Frame
This outcome will be assessed at the first day and after 4 weeks following end of treatment
Title
change in functional disability
Description
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.
Time Frame
This outcome will be assessed at the first day and after 4 weeks following end of treatment
Secondary Outcome Measure Information:
Title
change in Craniovertebral angle degree (CVA)
Description
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
Time Frame
This outcome will be assessed at the first day and after 4 weeks following end of treatment
Title
change of of deep neck flexor muscles (DNF) activation
Description
DNF activation will be assessed by Craniocervical flexion test using Pressure biofeedback unit
Time Frame
This outcome will be assessed at the first day and after 4 weeks following end of treatment
Title
change of deep neck flexor (DNF) endurance
Description
DNF endurance will be assessed by Neck flexor endurance test
Time Frame
This outcome will be assessed at the first day and after 4 weeks following end of treatment
Title
change of trunk flexor muscle endurance
Description
Trunk flexor muscle endurance will be assessed by Trunk flexion test (McGill's test)
Time Frame
This outcome will be assessed at the first day and after 4 weeks following end of treatment
Title
change of trunk extensor muscle endurance
Description
Trunk extensor muscle endurance will be assessed by Trunk extension test (Sorenson Test)
Time Frame
This outcome will be assessed at the first day and after 4 weeks following end of treatment
Title
change of lateral trunk muscle endurance
Description
Lateral trunk muscle endurance will be assessed Side plank test for left and right sides
Time Frame
This outcome will be assessed at the first day and after 4 weeks following end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, …).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hend W Mostafa, MSc
Phone
00201004225661
Email
hendwageh.95@gmail.com
Facility Information:
Facility Name
Faculty of Physical Therapy, Cairo University
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hend W Mostafa, MSc
Phone
00201004225661
Email
hendwageh.95@gmail.com

12. IPD Sharing Statement

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Effect of Lumber Core Stability Exercises on Chronic Non-specific Neck Pain

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