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Completed

NCT Number: NCT04299672

Cervical Functionality and Posture (CERFUPOS)

BACKGROUND: Musculoskeletal alterations of the cervical region constitute clinical situations with a high prevalence that may be related to posture mismatches. Static alterations not linked to a defined pathological picture may come from a sensory-motor disorder whose main manifestations are increased muscle tone and stiffness. Postural reconstruction (RP). The RP method has as main objective the rebalancing of the muscular tone from 1) the sensorimotor recovery and 2) the re-functionalization of the subcortical toninergic centers. The aim of this study is to determine the effect of this physiotherapeutic approach on the functionality and posture of the cervical region.

OBJECTIVES: 1) to know the effect of PR on cervical function in subjects with impaired cervical motor function; and 2) to know the effect of PR on static in subjects with impaired cervical motor function.

PARTICIPANTS & METHODS: quasi-experimental design, with only one intervention group (N=40). Data records before and after the 1st intervention, before the 2nd, 4th and 6th weekly treatment sessions, at 15 days and a month and at 3 months after the end of treatment.

INTERVENTION: The intervention will consist of the application of a RP maneuver applied to both lower limbs to obtain improvements in the cranio-cervical region.

OUTCOMES: The outcome variables will collect information on active joint movement in the cervical region, anatomical references representative of body statics, cervical repositioning, cervical disability, pain and time to extinction of the effect.

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Key information

Conditions

People With Impaired Motor Function in the Cervical Region Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

José Ríos-Díaz

Madrid, 28036, Spain

About this study

SAMPLE: People between 18-45 years old and with 1) alteration of active cervical mobility in at least one of the six directions of analytic movement compared to normality or with alteration of motor control of the cervical region in at least one of the 7 tests included in the study compared to normal criteria.

SAMPLE SIZE: The minimum size required has been calculated using the program G*Power 3.1.3 for Windows (University Kiel, Germany, 2008) based on an effect size of 0.5, type I error of 5%,type II error of 10%, an effect size of delta=0.20, a intra-measures correlation =0.5 for 7 measurement points. An extra 20% for drop-outs was added. The final sample size is N=40.

INTERVENTION:

Maximum external rotation of the hip in lower limb elevation and the dorsal flexion of the ankle with flexion of the toes, performed in both lower limbs alternately and independently. During the performance of the technique, the patient must implement the work breathing learned in the first basal assessment session.

It will be applied weekly during 6 consecutive weeks.

DATA ANALYSIS:

  • -Database cleaning and out-of-range data detection using Excel validation techniques.
  • -For statistical analysis, a descriptive analysis using means and standard deviations will be performed, as well as ranges and quartiles for quantitative measurements. Qualitative variables shall be summarised by counts and frequencies. The assumption of normality (Kolmogorv-Smirnoff test) and sphericity (Maulchy's test) prior to the analysis of variance (ANOVA) will be checked for repeated measurements in which only the intra-unit factors (7 time measurements). Pair comparisons were made with the Dunn-Bonferroni correction for type I erro and the age, sex and BMI variables were entered into the model as covariates to estimate their possible effect on the dependent variables.

The percentages of change from the baseline values in the intragroup comparison shall be calculated. The effect size will be estimated with the Hedges' g statistic.

The significance level will be set to p<0.05 and calculations will be performed with jmv r package for R (R Core Team, 2019. R: A language and environment for statistical. computing. R Foundation for Statistical Computing, Vienna, Austria. URL http://www.R-project.org/)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Alteration of active cervical mobility in at least one of the six directions of analytic movement compared to normality.
  • Alteration of motor control of the cervical region in at least one of the 7 tests included in the study, compared with the criteria of normality.

Exclusion criteria

  • Traumatic cervical history (whiplash, head trauma, etc.)
  • Diagnosis of degenerative diseases of any origin or known cervical degenerative signs.
  • Diagnosis of diseases of neurological origin or cerebrovascular alteration.
  • Diagnosis of cardiovascular or respiratory disease affecting the pattern of ventilation.
  • Pharmacological treatment (muscle relaxants, analgesics or anti-inflammatories) up to 4 weeks before the start of the study or during the study on a regular basis.
  • Pregnant

Treatment and study plan

Postural reconstruction

Procedure

Interventions are described in group descriptions

Primary outcomes

  1. Change in Craniovertebral angle

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    The craniovertebral angle is defined as the angle between the line from the external auditory meatus to the seventh cervical vertebra and a horizontal line at the level of the seventh cervical vertebra. The measure will be carried out with the KINOVEA system in degrees.

  2. Change in Sternum-mentonian distance

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    The Sternum-mentonian distance is the distance between the distal end of the mentonand the proximal end of the sternal notch. The measure will be carried out with the KINOVEA system in centimeters.

  3. Change in Head-neck asymmetry in the frontal plane

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Head-neck asymmetry in the frontal plane is the deviation of the fronto-naso-mentonian line from the vertical line of the body axis. The measure will be carried out with the KINOVEA system in centimeters.

  4. Change in Displacement of the center of masses

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Displacement of the center of masses by means of a Dinascan/IBV dynamometer platform with NedSVE/IB balance evaluation system.

  5. Change in Upper cervical active rotation test

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Upper cervical active rotation on 4 supports. The correct movement pattern implies that the patient is able to dissociate the upper rotation movement.

  6. Change in Upper cervical active flexion test

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Upper cervical active flexion on 4 supports. The correct movement pattern implies that the sagittal movement axis is correct and balanced. The normal bending movement must be "clean" and regular in the upper and lower cervical area, almost touching the sternum

  7. Change in Active cervical extension in seating test

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Active cervical extension in seating. The correct pattern should be smooth and uniform top, middle, bottom. NO HINGES. The face line stays about 15 - 20º from the horizontal.

  8. Change in Recover neutral position from cervical extension test

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Return to the neutral position from the active cervical extension position when seated. The correct pattern is soft starting with the cranio-cervical area and continuing with the rest of the cervical spine.

  9. Change in Active bilateral flexion of shoulders test

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Active bilateral bending of both upper limbs in standing position. The cervical spine should remain static during the 180º of bilateral upper limb elevation.

  10. Change in Active unilateral flexion of shoulders test

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Active unilateral bending of both upper limbs in standing position. The cervical spine should remain static during the 180º of unilateral upper limb elevation.

  11. Change in Rear balancing on 4 supports test

    Time frame: Pre-intervention, immediately post-intervention, 2nd, 4th, 6th intervention, 15, 30 days post-intervention and 3 months post-intervention

    During the sitting gesture on the heels the cervical spine should be static.

  12. Change in Cervical discapacity

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Neck disability Index. The NDI is a modification of the Oswestry Low Back Pain Disability Index . It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation with a range from 0 (no activity limitations) to 50 (complete activity limitation)

  13. Change in Cervical pain

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Numeric Pain Rating Scale in a range from 0 (no pain) to 100 (maximum pain).

Secondary outcomes

  1. Change in Cervical Flexion

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Cervical flexion with goniometry (in degrees)

  2. Change in Cervical Extension

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Cervical extension with goniometry (in degrees)

  3. Change in Cervical Inclination

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Cervical inclination bilaterally with goniometry (in degrees).

  4. Change in Cervical Rotation

    Time frame: Pre-intervention, immediately after first intervention, post-2nd-intervention(2 weeks), post-4th-intervention (4 weeks), post-6th-intervention (6 weeks) and follow-up at 15 days, 30 days and 3 months

    Cervical rotation bilaterally with goniometry (in degrees).

Sponsors and collaborators

Lead sponsor

Universidad Antonio de Nebrija

Other

Registry information

Official study title

Effect of Postural Reconstruction on the Functionality of the Cervical Region

Acronym: CERFUPOS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2020
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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