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Comparison Between Effect of Posterior Cervical Weighting and Deep Cervical Flexion Exercise on Forward Head Posture (FHP)

Primary Purpose

Postural Kyphosis, Neck Pain, Deformity of Spine

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Neck orthosis - with posterior cervical weight
Deep cervical flexors exercise
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postural Kyphosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Ethics Committee - Alexandria Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neck orthosis - posterior cervical weight

Deep cervical flexors exercise

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2021
Last Updated
April 18, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04796051
Brief Title
Comparison Between Effect of Posterior Cervical Weighting and Deep Cervical Flexion Exercise on Forward Head Posture
Acronym
FHP
Official Title
Comparison Between Effect of Posterior Cervical Weighting and Deep Cervical Flexion Exercise on Forward Head Posture: Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria 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
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.
Detailed Description
One of the most common postural deformities in the neck region is forward head posture seen in 66% of the population according to the American Physical Therapy Association. The use of computers and smartphones and long readings, which are the result of today's technological lifestyle, is one of the most common causes of FHP, causing the body to lean forward for hours. Maintaining the reverse neck posture also forces the body into many bad postures that damage the spine. Although forward head posture is experienced unconsciously at first, this unbalanced posture will accompany various degrees of advanced head posture, which turns into deformity, symptoms and complications. FHP is an anterior translation of the head characterized by the extension of the upper cervical vertebra C1 and 2 and the bending of the lower cervical vertebra. According to Kapandji, each inch (2.54 cm) of the head forward equals the extra 4.5 kg on the neck extensor muscle, which leads to muscle fatigue and weakness, resulting in an unbalanced head posture with an abnormal bow in the neck. Immunohistochemical studies conducted by Satoshi Inami and colleagues showed that there is damage to the synovial folds containing nociceptive nerve endings as a result of compression of the facet joints in the forward head posture. Aim of the work The aim of this study is to present a neck orthosis to correct neck posture and to see how posture correction will reflect on balance and plantar pressure distribution in individuals with forward head posture. This study can help answer questions about changes in gait level and mechanics between the spine and peripheral levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Kyphosis, Neck Pain, Deformity of Spine, Deformity, Muscle Weakness, Neck Syndrome, Forward Head Posture, Brace

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Neck orthosis - posterior cervical weight
Arm Type
Experimental
Arm Description
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
Arm Title
Deep cervical flexors exercise
Arm Type
Active Comparator
Arm Description
Deep cervical flexors exercise group will do 15 repetitions x 3 sets of deep neck flexor exercises every day of the week.
Intervention Type
Device
Intervention Name(s)
Neck orthosis - with posterior cervical weight
Other Intervention Name(s)
Posterior cervical neck weight - Azzkol Orthosis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Deep cervical flexors exercise
Other Intervention Name(s)
Deep cervical flexors activation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Craniovertebral Angle (CVA)
Description
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
Time Frame
6 weeks
Title
Neck Disability Index (NDI)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ossama Ragai, PHD Prof
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ethics Committee - Alexandria Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt

12. IPD Sharing Statement

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Comparison Between Effect of Posterior Cervical Weighting and Deep Cervical Flexion Exercise on Forward Head Posture

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