Individuals With Forward Head PostureNCT06439472
Effectiveness of the Suboccipital Inhibition Technique in Forward Head Posture.
A study testing Suboccipital Inhibition Technique in people with Individuals With Forward Head Posture, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
In this randomized controlled experimental trial, it is aimed to verify the effectiveness of applying the suboccipital inhibition technique in altering forward head posture, increasing the craniovertebral angle and decreasing the angle between the chin, the external acoustic meatus and the sternal angle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Individuals With Forward Head Posture
- What is being tested?
- Suboccipital Inhibition Technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2024to Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male and female;
- be over 18 years old;
- have a craniovertebral angle of less than 49.9º.
Who cannot join
- have a craniovertebral angle greater than 49.9º;
- be a 3rd or 4th year osteopathy student;
- be an osteopath.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Saúde do Porto
Porto, 4200-072
Natália MO Campelo, PhD, +35122 206 1000, nmc@ess.ipp.pt
About this study
Official title: Effectiveness of the Suboccipital Inhibition Technique in Individuals With Forward Head Posture: Randomized Controlled Trial
In this randomized controlled experimental trial, it is aimed to verify the effectiveness of applying the suboccipital inhibition technique in altering forward head posture, increasing the craniovertebral angle and decreasing the angle between the chin, the external acoustic meatus and the sternal angle.
Read the detailed description
Forward head posture (FHP) is defined as misalignment of the head caused by anterior translation of the head in relation to the trunk, The incidence rate of this postural alteration is 66% in individuals between the ages of 20 and 50.
In order to diagnose this alteration, two angles are used: the craniovertebral angle (CVA) and the angle between the chin, the external acoustic meatus and the sternal angle (AMME), with the CVA being the reference angle for diagnosing a FHP. According to the literature, when the CVA is less than 49.9º, there is a FHP.
We decided to use the suboccipital inhibition technique, which according to Eileen DiGiovanna et al (2005), causes a decrease in muscle tension leading to their relaxation. This relaxation, according to Heredia Rizo et al (2012), has significant effects on increasing CVA, which in turn will decrease AMME, resulting in a positive change in FHP.
- Conditions
- Individuals With Forward Head Posture
- Being tested
- Suboccipital Inhibition Technique, Sham Technique
- Keywords
- Forward head posture; Craniovertebral angle; Suboccipital muscles; Osteopathy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suboccipital Inhibition TechniqueOther
The researcher will place their palms under the patient's head and use their fingers to contact the occipital condyles. Next, the researcher will place the 3rd and 4th fingers of each hand in the space between the occiput and the spinous process of C2. The metacarpophalangeal joints are at 90º flexion, with the base of the skull resting on their hands while they apply constant, non-painful pressure in a postero-anterior direction, keeping the 2nd, 3rd and 4th fingers together in extension. Afterwards, the researcher applies a light and gentle traction in a cephalad direction in order to relieve the suboccipital area. Once the suboccipital muscles have relaxed, the researcher gently removes the contact, leaving the participant's head resting on the table.
This technique is performed for 4 minutes.
Sham TechniqueOther
The participant is instructed to lie down in the supine position while the mediator assumes a position at the head of the table and places their hands on the participant's shoulders. This technique is performed for 4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Suboccipital Inhibition Technique | Experimental | Experimental: Suboccipital Inhibition Technique Receives: Other: Suboccipital Inhibition Technique |
| Sham Technique | Placebo comparator | Placebo Comparator: Sham Technique Receives: Other: Sham Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craniovertebral angle
To obtain the craniovertebral angle, the SAPO postural assessment software will be used. This angle will be measured in the sagittal plane, with the participant sitting on a chair with their feet shoulder-width apart, resting on the floor, forearms relaxed over their legs, looking at a fixed point positioned on the wall 1 meter in front of their eyes.
The SAPO software will determine the angle measurement. This procedure will be carried out 3 times in order to minimize the reading error.
Measured: Immediately after the intervention.
Angle between the chin, external acoustic meatus and the sternal angle.
To obtain this angle, the SAPO postural assessment software will be used. This angle will be measured in the sagittal plane, with the participant sitting on a chair with their feet shoulder-width apart, resting on the floor, forearms relaxed over their legs, looking at a fixed point positioned on the wall 1 meter in front of their eyes.
The SAPO software will determine the angle measurement. This procedure will be carried out 3 times in order to minimize the reading error.
Measured: Immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Individuals With Forward Head PostureStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Campelo, PhD, Principal investigator, Escola Superior de Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439472
- Sponsor's protocol ID
- OST1_016
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aggarwal, A., Nair, A., Palekar, TJ e Bhamare, D. (2022). Efeito da técnica de liberação suboccipital na postura anterior da cabeça: um estudo comparativo. Jornal Médico da Universidade Dr. DY Patil , 15 (4), 534-537.
Contractor, ES, Shah, S. e Dave, P. (2019). Estudar o efeito imediato da técnica de energia muscular suboccipital no ângulo craniovertebral e no ângulo crânio-horizontal em indivíduos com postura de cabeça anteriorizada. Int J Health Sci Res , 9 (3), 83.
Kim, BB, Lee, JH, Jeong, HJ e Cynn, HS (2016). Efeitos da liberação suboccipital com exercício de flexão craniocervical no alinhamento craniocervical e na atividade muscular cervical extrínseca em indivíduos com postura anterior da cabeça. Jornal de Eletromiografia e Cinesiologia , 30 , 31-37.
Weber, P., Corrêa, ECR, Milanesi, JM, Soares, JC, & Trevisan, ME (2012). Postura craniocervical: análise cefalométrica e biofotogramétrica. Revista Brasileira de Ciências Orais , 11 (3), 416-421.
DiGiovanna, E. L., Schiowitz, S., Dowling, D. J. (2005). Uma abordagem osteopática para diagnóstico e tratamento. Lippincott Williams & Wilkins.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Suboccipital Inhibition Technique in Individuals With Forward Head Posture: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06439472
- Acronym / sponsor ID
- OST1_016
- Conditions
- Individuals With Forward Head Posture
- Keywords
- Forward head posture; Craniovertebral angle; Suboccipital muscles; Osteopathy.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Jun 2024 (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.
In this randomized controlled experimental trial, it is aimed to verify the effectiveness of applying the suboccipital inhibition technique in altering forward head posture, increasing the craniovertebral angle and decreasing the angle between the chin, the external acoustic meatus and the sternal angle.
Detailed description
Forward head posture (FHP) is defined as misalignment of the head caused by anterior translation of the head in relation to the trunk, The incidence rate of this postural alteration is 66% in individuals between the ages of 20 and 50.
In order to diagnose this alteration, two angles are used: the craniovertebral angle (CVA) and the angle between the chin, the external acoustic meatus and the sternal angle (AMME), with the CVA being the reference angle for diagnosing a FHP. According to the literature, when the CVA is less than 49.9º, there is a FHP.
We decided to use the suboccipital inhibition technique, which according to Eileen DiGiovanna et al (2005), causes a decrease in muscle tension leading to their relaxation. This relaxation, according to Heredia Rizo et al (2012), has significant effects on increasing CVA, which in turn will decrease AMME, resulting in a positive change in FHP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suboccipital Inhibition Technique | Experimental | Other: Suboccipital Inhibition TechniqueExperimental: Suboccipital Inhibition Technique |
| Sham Technique | Placebo comparator | Other: Sham TechniquePlacebo Comparator: Sham Technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male and female;
- be over 18 years old;
- have a craniovertebral angle of less than 49.9º.
Key exclusion criteria (3 listed)
- have a craniovertebral angle greater than 49.9º;
- be a 3rd or 4th year osteopathy student;
- be an osteopath.
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 |
|---|---|---|
| Suboccipital Inhibition TechniqueThe researcher will place their palms under the patient's head and use their fingers to contact the occipital condyles. Next, the researcher will place the 3rd and 4th fingers of each hand in the space between the occiput and the spinous process of C2. The metacarpophalangeal joints are at 90º flexion, with the base of the skull resting on their hands while they apply constant, non-painful pressure in a postero-anterior direction, keeping the 2nd, 3rd and 4th fingers together in extension. Afterwards, the researcher applies a light and gentle traction in a cephalad direction in order to relieve the suboccipital area. Once the suboccipital muscles have relaxed, the researcher gently removes the contact, leaving the participant's head resting on the table. This technique is performed for 4 minutes. | Other | Suboccipital Inhibition Technique |
| Sham TechniqueThe participant is instructed to lie down in the supine position while the mediator assumes a position at the head of the table and places their hands on the participant's shoulders. This technique is performed for 4 minutes. | Other | Sham Technique |
Primary outcome
Craniovertebral angle
Time frame: Immediately after the intervention.
To obtain the craniovertebral angle, the SAPO postural assessment software will be used. This angle will be measured in the sagittal plane, with the participant sitting on a chair with their feet shoulder-width apart, resting on the floor, forearms relaxed over their legs, looking at a fixed point positioned on the wall 1 meter in front of their eyes. The SAPO software will determine the angle measurement. This procedure will be carried out 3 times in order to minimize the reading error.
Angle between the chin, external acoustic meatus and the sternal angle.
Time frame: Immediately after the intervention.
To obtain this angle, the SAPO postural assessment software will be used. This angle will be measured in the sagittal plane, with the participant sitting on a chair with their feet shoulder-width apart, resting on the floor, forearms relaxed over their legs, looking at a fixed point positioned on the wall 1 meter in front of their eyes. The SAPO software will determine the angle measurement. This procedure will be carried out 3 times in order to minimize the reading error.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- BackgroundAggarwal, A., Nair, A., Palekar, TJ e Bhamare, D. (2022). Efeito da técnica de liberação suboccipital na postura anterior da cabeça: um estudo comparativo. Jornal Médico da Universidade Dr. DY Patil , 15 (4), 534-537.
- BackgroundContractor, ES, Shah, S. e Dave, P. (2019). Estudar o efeito imediato da técnica de energia muscular suboccipital no ângulo craniovertebral e no ângulo crânio-horizontal em indivíduos com postura de cabeça anteriorizada. Int J Health Sci Res , 9 (3), 83.
- BackgroundKim, BB, Lee, JH, Jeong, HJ e Cynn, HS (2016). Efeitos da liberação suboccipital com exercício de flexão craniocervical no alinhamento craniocervical e na atividade muscular cervical extrínseca em indivíduos com postura anterior da cabeça. Jornal de Eletromiografia e Cinesiologia , 30 , 31-37.
- BackgroundWeber, P., Corrêa, ECR, Milanesi, JM, Soares, JC, & Trevisan, ME (2012). Postura craniocervical: análise cefalométrica e biofotogramétrica. Revista Brasileira de Ciências Orais , 11 (3), 416-421.
- BackgroundDiGiovanna, E. L., Schiowitz, S., Dowling, D. J. (2005). Uma abordagem osteopática para diagnóstico e tratamento. Lippincott Williams & Wilkins.
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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.
Natália MO Campelo, PhD principal investigator
Escola Superior de Saúde do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suboccipital Inhibition Technique in people with Individuals With Forward Head Posture, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. 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 Portugal. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natália MO Campelo, PhD (22 206 1000, nmc@ess.ipp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craniovertebral angle (time frame: Immediately after the intervention.). 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?
On the ClinicalTrials.gov record for NCT06439472, which also lists 5 linked publications.
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 4 Jun 2024.