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

Primary Purpose

Forward Head Posture, Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Craniocervical flexion training
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Forward Head Posture focused on measuring Neck pain, Forward head posture, Deep cervical flexors

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Saud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control Group

Arm Description

Experimental group received craniocervical flexion training for 4 weeks and postural advice

Control group received only postural advice

Outcomes

Primary Outcome Measures

Change in craniovertebral angle
Change in the craniovertebral angle is assessed from baseline at 4 weeks interval.

Secondary Outcome Measures

Change in Neck Disability Index
Change in Functional status is assessed from baseline at 4 weeks interval.
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.

Full Information

First Posted
July 5, 2020
Last Updated
July 9, 2020
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT04463199
Brief Title
Effects of Deep Cervical Flexors Training On Forward Head Posture, Neck Pain and Functional Status
Official Title
Effects of Deep Cervical Flexors Training On Forward Head Posture, Neck Pain and Functional Status in Adolescent Children Using Computer Regularly
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
August 12, 2019 (Actual)
Study Completion Date
September 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Forward Head Posture, Neck Pain
Keywords
Neck pain, Forward head posture, Deep cervical flexors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Experimental group received craniocervical flexion training for 4 weeks and postural advice
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group received only postural advice
Intervention Type
Other
Intervention Name(s)
Craniocervical flexion training
Intervention Description
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".
Primary Outcome Measure Information:
Title
Change in craniovertebral angle
Description
Change in the craniovertebral angle is assessed from baseline at 4 weeks interval.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Neck Disability Index
Description
Change in Functional status is assessed from baseline at 4 weeks interval.
Time Frame
4 weeks
Title
Change in Visual Analog Scale
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
King Saud University
City
Riyadh
ZIP/Postal Code
11433
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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