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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06131697
Other study ID # REC/RCR & AHS/23/0156
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 10, 2023
Est. completion date January 10, 2024

Study information

Verified date November 2023
Source Riphah International University
Contact Imran Amjad, PhD
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to determine the effect of McKenzie exercises with and without Sustained Natural Apophyseal glide on pain, disability, and craniocervical angle in adults with Text neck syndrome.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date January 10, 2024
Est. primary completion date December 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
McKenzie Exercises without Mulligan Mobilization
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.
McKenzie Exercises with Mulligan Mobilization
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.

Locations

Country Name City State
Pakistan Shalamar Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric pain rating scale (NPRS) 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
Primary Neck disability index (NDI) 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
Primary Photogrammetry for Craniocervical angle (image j software) 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. 4th week
Secondary Smartphone Addiction Scale 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
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