Neck SyndromeNCT06131697
Effects Of McKenzie Exercises With And Without Mulligan Mobilization In Text Neck Syndrome.
A study testing McKenzie Exercises without Mulligan Mobilization and McKenzie Exercises with Mulligan Mobilization in people with Neck Syndrome and Forward Head Posture, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Syndrome, Forward Head Posture
- What is being tested?
- McKenzie Exercises without Mulligan Mobilization and McKenzie Exercises with Mulligan Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2023to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Neck surgery Spinal infection or inflammatory disorder Diagnosed cases of disc prolapse, stenosis, herniation, spondylolisthesis and osteoporosis, torticollis, scoliosis.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shalamar Hospital
Lahore, Punjab Province, 54600
Usman Sarwar, FCPS Ortho, 03004280554, onlyawan@yahoo.com
Usman Sarwar, FCPS Ortho, 03326099065, onlyawan@yahoo.com
About this study
Official title: Effects Of McKenzie Exercises With And Without Mulligan Mobilization On Pain, Disability And Craniocervical Angle In Text Neck Syndrome.
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.
Read the 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.
- Conditions
- Neck Syndrome, Forward Head Posture
- Being tested
- McKenzie Exercises without Mulligan Mobilization, McKenzie Exercises with Mulligan Mobilization
- Keywords
- Text Neck Syndrome, McKenzie Exercises, Sustained Natural Apophyseal Glide, Neck Pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McKenzie Exercises without Mulligan MobilizationOther
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 MobilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| McKenzie Exercises without Mulligan Mobilization | Experimental | McKenzie Exercises including retraction with neck flexion, extension, lateral flexion and rotation exercises. Receives: 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. Receives: Other: McKenzie Exercises with Mulligan Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4th week
Secondary outcomes (1)
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.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start10 May 2023
- Primary completion10 Dec 2023 (estimated)
- Study completion10 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Raza, Principal investigator, Riphah International UniversityFizza Khan, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131697
- Sponsor's protocol ID
- REC/RCR & AHS/23/0156
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of McKenzie Exercises With And Without Mulligan Mobilization On Pain, Disability And Craniocervical Angle In Text Neck Syndrome.
- ClinicalTrials.gov ID
- NCT06131697
- Acronym / sponsor ID
- REC/RCR & AHS/23/0156
- Conditions
- Neck Syndrome, Forward Head Posture
- Keywords
- Text Neck Syndrome, McKenzie Exercises, Sustained Natural Apophyseal Glide, Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McKenzie Exercises without Mulligan Mobilization | Experimental | Other: McKenzie Exercises without Mulligan MobilizationMcKenzie Exercises including retraction with neck flexion, extension, lateral flexion and rotation exercises. |
| McKenzie Exercises with Mulligan Mobilization | Experimental | Other: McKenzie Exercises with Mulligan MobilizationMcKenzie Exercises including retraction with neck flexion, extension, lateral flexion and rotation exercises and Sustained Natural Apophyseal glide. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Neck surgery Spinal infection or inflammatory disorder Diagnosed cases of disc prolapse, stenosis, herniation, spondylolisthesis and osteoporosis, torticollis, scoliosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McKenzie Exercises without Mulligan MobilizationMcKenzie 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. | Other | McKenzie Exercises without Mulligan Mobilization |
| McKenzie Exercises with Mulligan MobilizationMcKenzie 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. | Other | McKenzie Exercises with Mulligan Mobilization |
Primary outcome
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.
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.
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.
1 secondary outcome
Smartphone Addiction Scale
Time frame: 1st day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Raza principal investigator
Riphah International University
Fizza Khan principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McKenzie Exercises without Mulligan Mobilization and McKenzie Exercises with Mulligan Mobilization in people with Neck Syndrome and Forward Head Posture, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (NPRS) (time frame: 4th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.