Cervical Functionality and Posture (CERFUPOS) (CERFUPOS)

September 30, 2021 updated by: José Ríos-Díaz, Universidad Antonio de Nebrija

Effect of Postural Reconstruction on the Functionality of the Cervical Region

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

  1. -Database cleaning and out-of-range data detection using Excel validation techniques.
  2. -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/)

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Comunidad De Madrid
      • Madrid, Comunidad De Madrid, Spain, 28036
        • José Ríos-Díaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Postural reconstruction

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 independent.

Participant must control breathing. The detail phases of a general intervention are:

  1. PASSIVE displacement of the segment until reaching CRITICAL AMPLITUDE, which corresponds to the light myofascial stress or to the appearance of evoked responses.
  2. ACTIVE MAINTENANCE of the critical amplitude.
  3. WORK BREATHING.
  4. INDUCTIVE ACTIVE APPLICATIONS with movements of great relative amplitude.
  5. FINISHING CRITERIA: reduction or extinction of evoked responses, patient fatigue or execution of the technique for 15 minutes without any of the above premises having been reached.
Procedure: Postural reconstruction
Interventions are described in group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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
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
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
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.
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
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.
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
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.
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
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.
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
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.
Pre-intervention, immediately post-intervention, 2nd, 4th, 6th intervention, 15, 30 days post-intervention and 3 months post-intervention
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)
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
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).
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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).
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
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).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Antonio de Nebrija

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2020

Primary Completion (Actual)

March 20, 2021

Study Completion (Actual)

March 20, 2021

Study Registration Dates

First Submitted

November 1, 2019

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PR_Cervical

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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