- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407089
Effectiveness of a Telerehabilitation Program Based on Specific Neck Exercises in Patients with Forward Head Posture.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Zaragoza, Spain, 50018
- Élite Fisioterapia, María Montessori 2.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Spinertial Group (SG)
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. |
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. |
|
No Intervention: Control Group (CG)
The subject continues activities of daily living without intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline and 6 weeks, 10 weeks, 14 weeks
|
|
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. |
Baseline and 6 weeks, 10 weeks, 14 weeks
|
|
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.
|
Baseline and 6 weeks, 10 weeks, 14 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Pilar Pardos-Aguilella, Universidad de Zaragoza
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C.I. PI24/164
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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