- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06131697
Effects Of McKenzie Exercises With And Without Mulligan Mobilization In Text Neck Syndrome.
Effects Of McKenzie Exercises With And Without Mulligan Mobilization On Pain, Disability And Craniocervical Angle In Text Neck Syndrome.
Study Overview
Status
Conditions
Detailed Description
Text neck syndrome is a condition that results from the repetitive use of electronic devices, causing the neck to flex forward or down for extended periods. This can lead to symptoms such as neck pain, reduced range of motion, weakened muscles, altered joint position, and postural changes such as forward head posture and rounded shoulders.
In this randomized clinical trial, forty eight participants with text neck syndrome will be randomly assigned to one of the two intervention groups:
Group A :McKenzie Exercises without Mulligan mobilization and Group B:McKenzie Exercises with Mulligan mobilization . Randomization will be performed using a convenient random sampling method via sealed opaque envelopes. Each participant will receive a total of eight treatment sessions over a four-week period. The efficacy of the interventions will be assessed at the beginning (first session), conclusion (eight session). Outcome measures, including pain intensity, disability levels and craniocervical angle will be evaluated using the Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI) and Image J software, respectively. Data will be analyzed using SPSS software version 26. Normality of data will be assessed using the Kolmogorov Smirnov test. For within-group comparisons, either repeated measures ANOVA or the Friedman test will be used. To compare changes between the groups, the independent t-test or Mann-Whitney U test will be applied, depending on the data distribution. The analysis of these outcome measures will provide valuable insights into the impact of the interventions on participants' symptoms and postural alignment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Imran Amjad, PhD
- Phone Number: 051-5481826
- Email: imran.amjad@riphah.edu.pk
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54600
- Recruiting
- Shalamar Hospital
-
Contact:
- Usman Sarwar, FCPS Ortho
- Phone Number: 03004280554
- Email: onlyawan@yahoo.com
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Contact:
- Usman Sarwar, FCPS Ortho
- Phone Number: 03326099065
- Email: onlyawan@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age (18-35 years) Male and Female CVA <49° Using smart phone for more than 5 hours a day Having history of more than 3 months Score more than 3 on NPRS and more than 10 on NDI Score of SAS> 88
Exclusion Criteria:
Neck surgery Spinal infection or inflammatory disorder Diagnosed cases of disc prolapse, stenosis, herniation, spondylolisthesis and osteoporosis, torticollis, scoliosis.
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: McKenzie Exercises without Mulligan Mobilization
McKenzie Exercises including retraction with neck flexion, extension, lateral flexion and rotation exercises.
|
McKenzie Exercises will be comprised of four exercise programs.
Retraction with neck flexion, extension, lateral flexion and rotation exercises.
Each exercise will be performed with two sets of 10 reps with 10 secs hold twice a week for the time period of four weeks.
|
Experimental: McKenzie Exercises with Mulligan Mobilization
McKenzie Exercises including retraction with neck flexion, extension, lateral flexion and rotation exercises and Sustained Natural Apophyseal glide.
|
McKenzie Exercises will be comprised of four exercise programs. Retraction with neck flexion, extension, lateral flexion and rotation exercises. Each exercise will be performed with two sets of 10 reps with 10 secs hold twice a week for the time period of four weeks. Along McKenzie exercises Sustained Natural Apophyseal Glide will be given with the tip of thumb placed at an angle of 45° along the eyeball direction reinforced by another thumb. This exercise will be performed for three sets of six repetitions twice a week for the time period of four weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric pain rating scale (NPRS)
Time Frame: 4th week
|
The NPRS is a subjective pain rating scale using an 11-point scale from 0 to 10, where 0 means 'no pain' and 10 means 'intolerable pain'.
Participants select the whole number that best represents their level of pain.
The reliability is >0.95 with ICC values 0.86-0.95.
|
4th week
|
Neck disability index (NDI)
Time Frame: 4th week
|
NDI has 10 domains covering pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation.
Scores range from 0 to 50, with 50 being the greatest levels of dysfunction.
It is a valid and realiable tool with ICC=0.98.
|
4th week
|
Photogrammetry for Craniocervical angle (image j software)
Time Frame: 4th week
|
Craniocervical angle can be measured using the lateral photos exposing C7 and the ear.
The participants will maintain the natural head posture through the measurement method of self-balance posture.
It is the angle made by the line that connects the seventh cervical spine with the tragus and the horizontal line of the seventh cervical spine in the sitting and standing positions.
A CVA of <49° is characterized as FHP.
Image J is an image processing and analysis program that can read both image file formats and raw formats.
It can display, edit, analyze, process, store, and print images, as well as measure distances and angles.
It has been introduced as a reliable assessment tool used to measure cervical angles in several studies on forward head posture with ICC of 0.997.
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4th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smartphone Addiction Scale
Time Frame: 1st day
|
This scale is used for the recruitment of participants in the study.
It is a scale for smartphone addiction that consisted of 6 factors and 33 items with a six-point Likert scale (1: "strongly disagree" and 6: "strongly agree") based on self-reporting.
The six factors were daily-life disturbance, positive anticipation, withdrawal, cyberspace-oriented relationship, overuse, and tolerance.
Smartphone addiction was categorized as low if total score of a participant was between 33 and 87, intermediate if it was between 88 and 142 and high if score was between 143 and 198.
|
1st day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali Raza, Riphah International University
- Principal Investigator: Fizza Khan, Riphah International 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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0156
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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