Forward Head PostureNCT04463199
Effects of Deep Cervical Flexors Training On Forward Head Posture, Neck Pain and Functional Status
A study testing Craniocervical flexion training in people with Forward Head Posture and Neck Pain, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Forward Head Posture, Neck Pain
- What is being tested?
- Craniocervical flexion training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Feb 2019to 2 Sep 2019
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Forward Head Posture, Neck Pain
- Being tested
- Craniocervical flexion training
- Keywords
- Neck pain, Forward head posture, Deep cervical flexors
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniocervical flexion trainingOther
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".
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental group received craniocervical flexion training for 4 weeks and postural advice Receives: Other: Craniocervical flexion training |
| Control Group | No intervention | Control group received only postural advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in craniovertebral angle
Change in the craniovertebral angle is assessed from baseline at 4 weeks interval.
Measured: 4 weeks
Secondary outcomes (2)
Change in Neck Disability Index
Change in Functional status is assessed from baseline at 4 weeks interval.
Measured: 4 weeks
Change in Visual Analog Scale
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start20 Feb 2019
- Primary completion12 Aug 2019
- Study completion2 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forward Head PostureStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463199
- Sponsor's protocol ID
- RRC-2019-08
- Status last verified
- Jul 2020
- First submitted
- 5 Jul 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Cervical Flexors Training On Forward Head Posture, Neck Pain and Functional Status in Adolescent Children Using Computer Regularly
- ClinicalTrials.gov ID
- NCT04463199
- Acronym / sponsor ID
- RRC-2019-08
- Conditions
- Forward Head Posture, Neck Pain
- Keywords
- Neck pain, Forward head posture, Deep cervical flexors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 9 Jul 2020 (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.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Craniocervical flexion trainingExperimental group received craniocervical flexion training for 4 weeks and postural advice |
| Control Group | No intervention | –Control group received only postural advice |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Craniocervical flexion trainingPBU 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". | Other | Experimental |
Primary outcome
Change in craniovertebral angle
Time frame: 4 weeks
Change in the craniovertebral angle is assessed from baseline at 4 weeks interval.
2 secondary outcomes
Change in Neck Disability Index
Time frame: 4 weeks
Change in Visual Analog Scale
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Craniocervical flexion training in people with Forward Head Posture and Neck Pain, run by King Saud University at 1 site in Saudi Arabia.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 13 Jul 2020. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in craniovertebral angle (time frame: 4 weeks). 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 13 Jul 2020.