Effects of Deep Cervical Flexors Training On Forward Head Posture, Neck Pain and Functional Status

July 9, 2020 updated by: Masood Khan, King Saud University

Effects of Deep Cervical Flexors Training On Forward Head Posture, Neck Pain and Functional Status in Adolescent Children Using Computer Regularly

Using computer for long hours is related to higher risk of computer related muscular disorders like forward head posture and neck pain. Deep cervical flexor muscles are important head-on-neck posture stabilizers thus their training may lead to improvement in forward head posture (FHP) and neck pain (NP).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In contemporary societies, computer use by children is a necessity and thus highly prevalent. Using computer for long hours is related to higher risk of computer-related muscular disorders like forward head posture and neck pain. Deep cervical flexor muscles are important head-on-neck posture stabilizers thus their training may lead to improvement in forward head posture (FHP) and neck pain (NP). Aim of study was to determine if 4 weeks of deep cervical flexors training is effective in alleviating neck pain and improving forward head posture in adolescent children using computer regularly. A pretest-posttest experimental group design was used. Subjects were randomly assigned into control group (receiving postural advice only) and experimental group (receiving deep cervical flexor training and postural advice). Dependent variables were measured on day 0 (at baseline) and after 4weeks of training. The photographic analysis was used for measuring forward head posture, visual analog scale (VAS) for neck pain intensity and Neck Disability Index (NDI) for functional disability. Experimental group received craniocervical flexion training for 4 weeks and postural advice. Control group received only postural advice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11433
        • King Saud University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Neck pain with or without headache, of duration more than 3 months and less than 1 year and 6 months, as identified by body discomfort chart and
  • Neck disability index value less than 24 (mild to moderate disability scores on NDI)
  • Forward head posture as identified by straight line down from external meatus falling anterior to shoulder and mid thorax.
  • Using computer for at least 3 hours a day for at least 4 days a week or more.

Exclusion Criteria:

  • Ongoing or previous history of spinal fracture
  • Ongoing or previous history of neurological signs
  • Ongoing or previous history of inflammatory disease
  • Ongoing or previous history of spinal tumor
  • Ongoing or previous history of spinal infection
  • Ongoing or previous history of spinal cord compression
  • Ongoing or previous history of congenital, or acquired postural deformity
  • Ongoing or previous history of cervical spinal surgery
  • Ongoing or previous history of spinal instability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Experimental group received craniocervical flexion training for 4 weeks and postural advice
Other: Craniocervical flexion training
PBU airbag was clipped together and folded in, fastened, and placed suboccipital. Uninflated pressure sensor was kept below the neck, so that it touched the occiput then inflated to a stable baseline pressure of 20 mmHg to just fill the space below the neck but not to push it into lordosis. Subjects were demonstrated the correct action of the deep cervical flexors that is gentle nodding of head as if saying "yes".
No Intervention: Control Group
Control group received only postural advice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in craniovertebral angle
Time Frame: 4 weeks
Change in the craniovertebral angle is assessed from baseline at 4 weeks interval.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Neck Disability Index
Time Frame: 4 weeks
Change in Functional status is assessed from baseline at 4 weeks interval.
4 weeks
Change in Visual Analog Scale
Time Frame: 4 weeks
Change in Neck pain intensity assessed from baseline at 4 weeks interval. It is a scale on a piece of paper equal to the length of 10 cm. Each centimeter has 1 point, with 0 means "no pain" and 10 means "worst pain felt ever". Lower the score, better the outcome measure.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RRC-2019-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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