NCT04796051

Brief Summary

It has been reported that the head protrudes forward relative to the body from the sagittal plane associated with the anterior shifting of the line of gravity (LOG) relative to the base of support (BOS). On the other hand, the center of gravity (COG) has changed with the forward head posture (FHP) and is related to mechanical and musculoskeletal modifications due to postural control, which affects the whole body balance. Griegel-Morris et al. Reported that, after evaluating eighty-eight healthy participants, 66% had a forward head posture (FHP). In addition, he stated that the inverted head posture in the forward head posture will not only cause neck problems, but also can extend to the shoulder joint and thoracic spine. As a result, it causes a general imbalance in the musculoskeletal system. Jung-Ho Kang and his colleagues examined the effect of daily sitting times of computer users on dynamic and static balance and stated that balance ability decreased in heavy computer users. Another study on forward head posture (IBP) revealed that it limits ankle joint movement, especially in ankle plantarflexion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

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

First Submitted

Initial submission to the registry

March 10, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

April 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

April 20, 2023

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 10, 2021

Last Update Submit

April 18, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Craniovertebral Angle (CVA)

    Cranio vertebral angle: Above 52 degrees will be considered as normal head posture, while less than 48 degrees will be considered as forward head posture

    6 weeks

  • Neck Disability Index (NDI)

    The scale consists of 20 questions, the intensity of the pain; researches in terms of recreational, professional, social and daily life functions and emotional factors. Maximum score is 50 (which is total maximum score) means severe neck disability. Minimum score is 0(which is total minimum score) means without any reported neck disability.

    6 weeks

Study Arms (2)

Neck orthosis - posterior cervical weight

EXPERIMENTAL

The posterior cervical weight orthosis is made of a well-padded adjustable Velcro attached to the end with a two-kilogram weight attached with two durable straps. The device is firmly anchored around the curvature of the jaw and attached with Velcro to the apex of the skull. Neck orthosis group will use a cervical orthosis (with the posterior cervical neck weight) for 10 minutes / 3 times a day, for a total of 30 minutes a day

Device: Neck orthosis - with posterior cervical weight

Deep cervical flexors exercise

ACTIVE COMPARATOR

Deep cervical flexors exercise group will do 15 repetitions x 3 sets of deep neck flexor exercises every day of the week.

Other: Deep cervical flexors exercise

Interventions

The posterior cervical weight orthosis is made of a well-padded adjustable Velcro attached to the end with a two-kilogram weight attached with two durable straps. The device is firmly anchored around the curvature of the jaw and attached with Velcro to the apex of the skull.

Also known as: Posterior cervical neck weight - Azzkol Orthosis
Neck orthosis - posterior cervical weight

The participant will lay down in crook lying position, participant's head relaxed on the flat surface. Each participant will passively tuck in his/her chin without activation of superficial cervical muscles. Participants of this group will do 15 repetitions x 3 sets of deep neck flexor exercises every day of the week.

Also known as: Deep cervical flexors activation
Deep cervical flexors exercise

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18 years and over willing to attend the study.
  • Individuals with craniovertebral angle (CVA) less than 48 degrees for those participating in forward head posture (FHP).
  • Young adults without known problems will be divided into groups by evaluating their craniovertebral angle value. (As individuals below 48 degrees).
  • Mechanical neck pain experienced / felt in the last 3 months.

You may not qualify if:

  • Spine trauma, surgery, bone pathology, arthritis, etc. Having a history of illness.
  • Kyphotic deformity types are rounded back, Scheuermann's disease, hunched back, flat back and Dowager hump.
  • Any spinal deformity, bone abnormality, postural deformity, and disc herniation with / without peripheral symptoms.
  • Body mass index (BMI)\> 30, which is an indicator of obesity.
  • Suffering from balance problems, coordination problems, and other neurological or vestibular diseases that affect body balance and posture.
  • Any orthopedic or neurological disease affecting the body joints or the integrity of the musculoskeletal system.
  • Use of any medication that can cause dizziness or drowsiness in the last months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ethics Committee - Alexandria Faculty of Medicine

Alexandria, 21131, Egypt

Location

MeSH Terms

Conditions

Neck PainCongenital AbnormalitiesMuscle Weakness

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNervous System DiseasesPathologic Processes

Study Officials

  • Ossama Ragai, PHD Prof

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
An external assessors would be invited to assess the study's participants before and after the treatment. The extensor assessor would be blind to which group he/she is assessing.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 61 healthy individuals aged 18-65 are planned to participate in our study. Each case will fill out a questionnaire and will be subjected to a detailed examination by checking whether there have any factors that would cause the participant to be excluded from the study. Participants meeting the criteria will be divided into two groups according to their degrees of craniovertebral angle (CVA) after their participation in the study is approved. Neck Injury Index: The scale consists of 20 questions, the intensity of the pain; researches in terms of recreational, professional, social and daily life functions and emotional factors. Each question consists of a 10 cm long visual analog scale. CVA above 52 degrees will be considered as normal head posture, while less than 48 degrees will be considered as forward head posture.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 12, 2021

Study Start

April 10, 2021

Primary Completion

August 15, 2021

Study Completion

September 1, 2021

Last Updated

April 20, 2023

Record last verified: 2021-03

Locations