NCT04463199

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

July 5, 2020

Last Update Submit

July 9, 2020

Conditions

Keywords

Neck painForward head postureDeep cervical flexors

Outcome Measures

Primary Outcomes (1)

  • Change in craniovertebral angle

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

    4 weeks

Secondary Outcomes (2)

  • Change in Neck Disability Index

    4 weeks

  • Change in Visual Analog Scale

    4 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

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

Other: Craniocervical flexion training

Control Group

NO INTERVENTION

Control group received only postural advice

Interventions

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".

Experimental

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 5, 2020

First Posted

July 9, 2020

Study Start

February 20, 2019

Primary Completion

August 12, 2019

Study Completion

September 2, 2019

Last Updated

July 13, 2020

Record last verified: 2020-07

Locations