Cervical Functionality and Posture (CERFUPOS)

NCT ID: NCT04299672

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-30
• Study Completion Date: 2021-03-20

Brief Summary

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.

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/)

Conditions

People With Impaired Motor Function in the Cervical Region

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Postural reconstruction

Intervention Type: PROCEDURE

Interventions are described in group descriptions

Interventions

Postural reconstruction

Interventions are described in group descriptions

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Antonio de Nebrija

OTHER

Sponsor Role: lead

Responsible Party

José Ríos-Díaz

Faculty-Reseacher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

José Ríos-Díaz

Madrid, Madrid, Spain

Countries

Spain

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Other Identifiers

PR_Cervical

Identifier Type: -

Identifier Source: org_study_id