Postural KyphosisFHPNCT04796051
Comparison Between Effect of Posterior Cervical Weighting and Deep Cervical Flexion Exercise on Forward Head Posture
A study testing Neck orthosis - with posterior cervical weight and Deep cervical flexors exercise in people with Postural Kyphosis and Neck Pain, run by Alexandria University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Kyphosis, Neck Pain, Deformity of Spine
- What is being tested?
- Neck orthosis - with posterior cervical weight and Deep cervical flexors exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Effect of Posterior Cervical Weighting and Deep Cervical Flexion Exercise on Forward Head Posture: Randomized Control Trial
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.
Read the 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.
- Conditions
- Postural Kyphosis, Neck Pain, Deformity of Spine, Deformity, Muscle Weakness, Neck Syndrome
- Being tested
- Neck orthosis - with posterior cervical weight, Deep cervical flexors exercise
- Medical subject headings
- Neck Pain, Congenital Abnormalities, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck orthosis - with posterior cervical weightDevice
Also called Posterior cervical neck weight - Azzkol Orthosis
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.
Deep cervical flexors exerciseOther
Also called Deep cervical flexors activation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Deep cervical flexors exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start10 Apr 2021
- Primary completion15 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural KyphosisStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ossama Ragai, PHD Prof, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796051
- Sponsor's protocol ID
- 0305072
- Acronym
- FHP
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Effect of Posterior Cervical Weighting and Deep Cervical Flexion Exercise on Forward Head Posture: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04796051
- Acronym / sponsor ID
- FHP / 0305072
- Conditions
- Postural Kyphosis, Neck Pain, Deformity of Spine, Deformity, Muscle Weakness, Neck Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Neck orthosis - posterior cervical weight | Experimental | Device: Neck orthosis - with posterior cervical weightThe 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 | Active comparator | Other: Deep cervical flexors exerciseDeep cervical flexors exercise group will do 15 repetitions x 3 sets of deep neck flexor exercises every day of the week. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck orthosis - with posterior cervical weightAlso: Posterior cervical neck weight - Azzkol OrthosisThe 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. | Device | Neck orthosis - posterior cervical weight |
| Deep cervical flexors exerciseAlso: Deep cervical flexors activationThe 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. | Other | Deep cervical flexors exercise |
Primary outcome
Craniovertebral Angle (CVA)
Time frame: 6 weeks
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)
Time frame: 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ossama Ragai, PHD Prof principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck orthosis - with posterior cervical weight and Deep cervical flexors exercise in people with Postural Kyphosis and Neck Pain, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craniovertebral Angle (CVA) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.