NCT06131697

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

November 9, 2023

Last Update Submit

November 9, 2023

Conditions

Keywords

Text Neck SyndromeMcKenzie ExercisesSustained Natural Apophyseal GlideNeck Pain

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Smartphone Addiction Scale

    1st day

Study Arms (2)

McKenzie Exercises without Mulligan Mobilization

EXPERIMENTAL

McKenzie Exercises including retraction with neck flexion, extension, lateral flexion and rotation exercises.

Other: McKenzie Exercises without Mulligan Mobilization

McKenzie Exercises with Mulligan Mobilization

EXPERIMENTAL

McKenzie Exercises including retraction with neck flexion, extension, lateral flexion and rotation exercises and Sustained Natural Apophyseal glide.

Other: McKenzie Exercises with Mulligan Mobilization

Interventions

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 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. 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.

McKenzie Exercises with Mulligan Mobilization

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Neck surgery Spinal infection or inflammatory disorder Diagnosed cases of disc prolapse, stenosis, herniation, spondylolisthesis and osteoporosis, torticollis, scoliosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalamar Hospital

Lahore, Punjab Province, 54600, Pakistan

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ali Raza

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Fizza Khan

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants of both group will be informed about the possible risks and potential benefits but they won't know which group they are placed in. The participants must sign consent forms agreeing to the experiment. Concealment will be done via sealed opaque envelopes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 14, 2023

Study Start

May 10, 2023

Primary Completion

December 10, 2023

Study Completion

January 10, 2024

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations