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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06407089
Other study ID # C.I. PI24/164
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 20, 2024
Est. completion date November 20, 2024

Study information

Verified date May 2024
Source Universitat Internacional de Catalunya
Contact Pilar Pardos-Aguilella
Phone 690651998
Email ppardos@uic.es ; ppardos@unizar.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 two months of follow-up.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date November 20, 2024
Est. primary completion date September 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination). Have received cervical manual therapy treatment during the last six month. A 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Spinertial Group
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.

Locations

Country Name City State
Spain E´lite Fisioterapia, Mari´a Montessori 2. Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
Universitat Internacional de Catalunya Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Craniovertebral angle (CV) The examiners assess the cranio-vertebral angle (CV), 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
Primary Cervical Spine range of motion 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
Primary Cervical Propioception 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
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