Forward Head PostureNCT06407089
Effectiveness of a Telerehabilitation Program Based on Specific Neck Exercises in Patients With Forward Head Posture.
A study testing Spinertial Group in people with Forward Head Posture and Neck Pain, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The aim of this study is to compare the effects of a 12-session telerehabilitation program based on Specific Neck Exercises (SNE) with Spinertial to a control group on range of motion, cervical proprioception, and posture in subjects with forward head posture, post-intervention, after one month of follow-up, and after… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Forward Head Posture, Neck Pain
- What is being tested?
- Spinertial Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2024to 20 Nov 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Forward head posture (craniovertebral angle less than 50º).
- Deep flexor strength deficit in craniocervical flexion test.
- Deep extensor strength deficit in neck extensor muscle endurance.
- ≤ 14 score in Neck Disability Index.
Who cannot join
- Have received cervical treatment during the last six months.
- Presence of any red flag, neurological, or cognitive impairment (inability to - - understand the questionnaires or examination).
- Have received cervical manual therapy treatment during the last six months.
- History of cervical trauma or surgery during the last year.
- Chronic neck pain occurring during the last six months (intensity: visual analogue scale >3/10, frequency >2 days/week, duration >3 hours/day).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the effects of a 12-session telerehabilitation program based on Specific Neck Exercises (SNE) with Spinertial to a control group on range of motion, cervical proprioception, and posture in subjects with forward head posture, post-intervention, after one month of follow-up, and after two months of follow-up.
Read the detailed description
Epidemiological evidence suggests that a sedentary lifestyle is associated with various musculoskeletal conditions, including neck pain. Sedentary behavior during work hours is closely linked to the craniovertebral angle (CVA). Forward head posture, associated with increased vertebral load, predisposes individuals to early onset of degenerative changes, cervical pain, and disability, as well as decreased endurance and strength of the cervical musculature.
Patients with cervical pain may exhibit various clinical manifestations, including weakness of the deep cervical musculature, reduced cervical range of motion (ROM), and cervical disability. Numerous pathologies are described to manifest with localized pain in the cervical region, as well as weakness of the deep cervical musculature and reduced craniovertebral angle (CVA). Examples include cervicogenic dizziness, cervicogenic headache, tension headache, cervical radiculopathy, cervical instability, or chronic mechanical cervicalgia.
The sensorimotor control system is a crucial component of the cervical spine. The deep musculature of the cervical region contains a large number of neuromuscular spindles and mechanoreceptors, providing information about the movement of the head and enhancing dynamic stability during neck movements. The density of neuromuscular spindles in the deep musculature is particularly high, suggesting a significant role in the fine motor control of the cervical spine. Impairment of cervical posture, decreased craniovertebral angle (CVA), proprioception, and alterations in the sensorimotor control system associated with neck pain contribute to recurrence and chronicity.
- Conditions
- Forward Head Posture, Neck Pain
- Being tested
- Spinertial Group
- Keywords
- telerrehabilitation, deep cervical muscles, neck muscles, exercise therapy, specific neck exercises
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinertial GroupOther
Endurance training program of deep cervical flexors and deep cervical extensors with Spinertial device for treatment.
Endurance training program of deep cervical flexors and deep cervical flexors with Spinertial device for treatment.
| Study group | Role | What they receive |
|---|---|---|
| Spinertial Group (SG) | Experimental | Endurance training program of deep cervical flexors and deep cervical extensors with Spinertial device for treatment.
Endurance training program of deep cervical flexors and deep cervical flexors with Spinertial device for treatment. Receives: Other: Spinertial Group |
| Control Group (CG) | No intervention | The subject continues activities of daily living without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Craniovertebral angle (CVA) from baseline
The examiners assess the cranio-vertebral angle (CVA), reflecting the forward head posture position, is the acute anglecreated between the horizontal plane and the line from the tip of the C7 spinous process to the tragion. Head postureis measure as the acute angle between the horizontal plane and the line from the corner of the eye to the tragion(ETH).
Measured: Baseline and 6 weeks, 10 weeks, 14 weeks
Mean Change in Cervical Spine Range of Motion (ROM) from Baseline.
Mean change from baseline in Lower and Upper Cervical Spine Range of Movement (ROM) in the sagittal, frontal and transverse planes after 6 weeks, 10 weeks, and 14 weeks.
The examiners assess cervical ROM using CROM (Cervical Range-of-Motion Instrument). Cervical flexion, extension, right/left side bending, and right/left rotation will be evaluated in the sagittal, frontal, and transverse planes.
The examiners assess cervical ROM using CROM (Cervical Range-of-Motion Instrument). Upper cervical flexion, upper cervical extension, and flexion rotation test will be evaluated in the frontal and transverse planes. The flexion rotation test is used to assess the movement of the upper cervical spine and is the most commonly used test in the literature. It is considered positive when there is a decrease of 10 degrees or more in cervical rotation with maximum flexion, in comparison to the contralateral side, or when there is hypomobility of segment C1 with mobility less than 32.
Measured: Baseline and 6 weeks, 10 weeks, 14 weeks
Mean Change in Joint Position error from baseline
Joint Position Error (JPE): The examiners assess the subject's ability (while blindfolded) to relocate the natural head posture (NHP) following the movements of left and right rotation, flexion and extension, upper flexion and upper extension. The relocation error (joint position error, JPE) is the difference between the starting position and the NHP after movement.
Measured: Baseline and 6 weeks, 10 weeks, 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start20 May 2024
- Primary completion20 Sep 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Zaragoza
- Responsible party
- Principal investigator, Pilar Pardos Aguilella, Universitat Internacional de Catalunya
- Investigators
- Pilar Pardos-Aguilella, Principal investigator, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407089
- Sponsor's protocol ID
- C.I. PI24/164
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Telerehabilitation Program Based on Specific Neck Exercises in Patients With Forward Head Posture.
- ClinicalTrials.gov ID
- NCT06407089
- Acronym / sponsor ID
- C.I. PI24/164
- Conditions
- Forward Head Posture, Neck Pain
- Keywords
- telerrehabilitation, deep cervical muscles, neck muscles, exercise therapy, specific neck exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Universidad de Zaragoza
- Study start
- 20 May 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 9 May 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.
The aim of this study is to compare the effects of a 12-session telerehabilitation program based on Specific Neck Exercises (SNE) with Spinertial to a control group on range of motion, cervical proprioception, and posture in subjects with forward head posture, post-intervention, after one month of follow-up, and after two months of follow-up.
Detailed description
Epidemiological evidence suggests that a sedentary lifestyle is associated with various musculoskeletal conditions, including neck pain. Sedentary behavior during work hours is closely linked to the craniovertebral angle (CVA). Forward head posture, associated with increased vertebral load, predisposes individuals to early onset of degenerative changes, cervical pain, and disability, as well as decreased endurance and strength of the cervical musculature.
Patients with cervical pain may exhibit various clinical manifestations, including weakness of the deep cervical musculature, reduced cervical range of motion (ROM), and cervical disability. Numerous pathologies are described to manifest with localized pain in the cervical region, as well as weakness of the deep cervical musculature and reduced craniovertebral angle (CVA). Examples include cervicogenic dizziness, cervicogenic headache, tension headache, cervical radiculopathy, cervical instability, or chronic mechanical cervicalgia.
The sensorimotor control system is a crucial component of the cervical spine. The deep musculature of the cervical region contains a large number of neuromuscular spindles and mechanoreceptors, providing information about the movement of the head and enhancing dynamic stability during neck movements. The density of neuromuscular spindles in the deep musculature is particularly high, suggesting a significant role in the fine motor control of the cervical spine. Impairment of cervical posture, decreased craniovertebral angle (CVA), proprioception, and alterations in the sensorimotor control system associated with neck pain contribute to recurrence and chronicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinertial Group (SG) | Experimental | Other: Spinertial GroupEndurance training program of deep cervical flexors and deep cervical extensors with Spinertial device for treatment. Endurance training program of deep cervical flexors and deep cervical flexors with Spinertial device for treatment. |
| Control Group (CG) | No intervention | –The subject continues activities of daily living without intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Forward head posture (craniovertebral angle less than 50º).
- Deep flexor strength deficit in craniocervical flexion test.
- Deep extensor strength deficit in neck extensor muscle endurance.
- ≤ 14 score in Neck Disability Index.
Key exclusion criteria (5 listed)
- Have received cervical treatment during the last six months.
- Presence of any red flag, neurological, or cognitive impairment (inability to - - understand the questionnaires or examination).
- Have received cervical manual therapy treatment during the last six months.
- History of cervical trauma or surgery during the last year.
- Chronic neck pain occurring during the last six months (intensity: visual analogue scale >3/10, frequency >2 days/week, duration >3 hours/day).
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 |
|---|---|---|
| Spinertial GroupEndurance training program of deep cervical flexors and deep cervical extensors with Spinertial device for treatment. Endurance training program of deep cervical flexors and deep cervical flexors with Spinertial device for treatment. | Other | Spinertial Group (SG) |
Primary outcome
Mean Change in Craniovertebral angle (CVA) from baseline
Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks
The examiners assess the cranio-vertebral angle (CVA), reflecting the forward head posture position, is the acute anglecreated between the horizontal plane and the line from the tip of the C7 spinous process to the tragion. Head postureis measure as the acute angle between the horizontal plane and the line from the corner of the eye to the tragion(ETH).
Mean Change in Cervical Spine Range of Motion (ROM) from Baseline.
Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks
Mean change from baseline in Lower and Upper Cervical Spine Range of Movement (ROM) in the sagittal, frontal and transverse planes after 6 weeks, 10 weeks, and 14 weeks. The examiners assess cervical ROM using CROM (Cervical Range-of-Motion Instrument). Cervical flexion, extension, right/left side bending, and right/left rotation will be evaluated in the sagittal, frontal, and transverse planes. The examiners assess cervical ROM using CROM (Cervical Range-of-Motion Instrument). Upper cervical flexion, upper cervical extension, and flexion rotation test will be evaluated in the frontal and transverse planes. The flexion rotation test is used to assess the movement of the upper cervical spine and is the most commonly used test in the literature. It is considered positive when there is a decrease of 10 degrees or more in cervical rotation with maximum flexion, in comparison to the contralateral side, or when there is hypomobility of segment C1 with mobility less than 32.
Mean Change in Joint Position error from baseline
Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks
Joint Position Error (JPE): The examiners assess the subject's ability (while blindfolded) to relocate the natural head posture (NHP) following the movements of left and right rotation, flexion and extension, upper flexion and upper extension. The relocation error (joint position error, JPE) is the difference between the starting position and the NHP after movement.
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 17 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Pilar Pardos-Aguilella principal investigator
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinertial Group in people with Forward Head Posture and Neck Pain, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 5 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 17 Mar 2025. 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 Spain. 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?
Mean Change in Craniovertebral angle (CVA) from baseline (time frame: Baseline and 6 weeks, 10 weeks, 14 weeks). The study lists 3 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 17 Mar 2025.