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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04463199
Other study ID # RRC-2019-08
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2019
Est. completion date September 2, 2019

Study information

Verified date July 2020
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2, 2019
Est. primary completion date August 12, 2019
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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".

Locations

Country Name City State
Saudi Arabia King Saud University Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in craniovertebral angle Change in the craniovertebral angle is assessed from baseline at 4 weeks interval. 4 weeks
Secondary Change in Neck Disability Index Change in Functional status is assessed from baseline at 4 weeks interval. 4 weeks
Secondary 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. 4 weeks
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