People With Impaired Motor Function in the Cervical RegionCERFUPOSNCT04299672
Cervical Functionality and Posture (CERFUPOS)
A study testing Postural reconstruction in people with People With Impaired Motor Function in the Cervical Region, run by Universidad Antonio de Nebrija at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- People With Impaired Motor Function in the Cervical Region
- What is being tested?
- Postural reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2020to 20 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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:
- -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/)
- Being tested
- Postural reconstruction
- Keywords
- Cervical pain, Funcionality, Posture, Balance, Muscular tone, Postural reconstruction, Physical Therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural reconstructionProcedure or surgery
Interventions are described in group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Postural reconstruction | Experimental | 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. Receives: Procedure: Postural reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Craniovertebral angle
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Displacement of the center of masses by means of a Dinascan/IBV dynamometer platform with NedSVE/IB balance evaluation system.
Measured: 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
Upper cervical active rotation on 4 supports. The correct movement pattern implies that the patient is able to dissociate the upper rotation movement.
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
Active bilateral bending of both upper limbs in standing position. The cervical spine should remain static during the 180º of bilateral upper limb elevation.
Measured: 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
Active unilateral bending of both upper limbs in standing position. The cervical spine should remain static during the 180º of unilateral upper limb elevation.
Measured: 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
During the sitting gesture on the heels the cervical spine should be static.
Measured: Pre-intervention, immediately post-intervention, 2nd, 4th, 6th intervention, 15, 30 days post-intervention and 3 months post-intervention
Change in Cervical discapacity
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)
Measured: 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
Numeric Pain Rating Scale in a range from 0 (no pain) to 100 (maximum pain).
Measured: 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 outcomes (4)
Change in Cervical Flexion
Cervical flexion with goniometry (in degrees)
Measured: 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
Cervical extension with goniometry (in degrees)
Measured: 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
Cervical inclination bilaterally with goniometry (in degrees).
Measured: 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
Cervical rotation bilaterally with goniometry (in degrees).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start30 Mar 2020
- Primary completion20 Mar 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for People With Impaired Motor Function in the Cervical RegionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Antonio de Nebrija
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Ríos-Díaz, Universidad Antonio de Nebrija
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299672
- Sponsor's protocol ID
- PR_Cervical
- Acronym
- CERFUPOS
- Status last verified
- Sep 2021
- First submitted
- 1 Nov 2019
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
PubMed 15999284Sempere-Rubio N, Aguilar-Rodriguez M, Espi-Lopez GV, Cortes-Amador S, Pascual E, Serra-Ano P. Impaired Trunk Posture in Women With Fibromyalgia. Spine (Phila Pa 1976). 2018 Nov 15;43(22):1536-1542. doi: 10.1097/BRS.0000000000002681.
PubMed 29652782Kim EK, Kim JS. Correlation between rounded shoulder posture, neck disability indices, and degree of forward head posture. J Phys Ther Sci. 2016 Oct;28(10):2929-2932. doi: 10.1589/jpts.28.2929. Epub 2016 Oct 28.
PubMed 27821964Kim JY, Kwag KI. Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain. J Phys Ther Sci. 2016 Jan;28(1):269-73. doi: 10.1589/jpts.28.269. Epub 2016 Jan 30.
PubMed 26957772Griegel-Morris P, Larson K, Mueller-Klaus K, Oatis CA. Incidence of common postural abnormalities in the cervical, shoulder, and thoracic regions and their association with pain in two age groups of healthy subjects. Phys Ther. 1992 Jun;72(6):425-31. doi: 10.1093/ptj/72.6.425.
PubMed 1589462Ferracini GN, Chaves TC, Dach F, Bevilaqua-Grossi D, Fernandez-de-Las-Penas C, Speciali JG. Relationship Between Active Trigger Points and Head/Neck Posture in Patients with Migraine. Am J Phys Med Rehabil. 2016 Nov;95(11):831-839. doi: 10.1097/PHM.0000000000000510.
PubMed 27149581Malmstrom EM, Olsson J, Baldetorp J, Fransson PA. A slouched body posture decreases arm mobility and changes muscle recruitment in the neck and shoulder region. Eur J Appl Physiol. 2015 Dec;115(12):2491-503. doi: 10.1007/s00421-015-3257-y. Epub 2015 Oct 1.
PubMed 26429723Janda V. On the concept of postural muscles and posture in man. Aust J Physiother. 1983 Jun;29(3):83-4. doi: 10.1016/S0004-9514(14)60665-6.
PubMed 25025491Wilke J, Krause F, Vogt L, Banzer W. What Is Evidence-Based About Myofascial Chains: A Systematic Review. Arch Phys Med Rehabil. 2016 Mar;97(3):454-61. doi: 10.1016/j.apmr.2015.07.023. Epub 2015 Aug 14.
PubMed 26281953Krause F, Wilke J, Vogt L, Banzer W. Intermuscular force transmission along myofascial chains: a systematic review. J Anat. 2016 Jun;228(6):910-8. doi: 10.1111/joa.12464. Epub 2016 Mar 22.
PubMed 27001027Destieux C, Gaudreault N, Isner-Horobeti ME, Vautravers P. Use of Postural Reconstruction(R) physiotherapy to treat an adolescent with asymmetric bilateral genu varum and idiopathic scoliosis. Ann Phys Rehabil Med. 2013 May;56(4):312-26. doi: 10.1016/j.rehab.2013.02.004. Epub 2013 Mar 20.
PubMed 23541175Weiler C, Schietzsch M, Kirchner T, Nerlich AG, Boos N, Wuertz K. Age-related changes in human cervical, thoracal and lumbar intervertebral disc exhibit a strong intra-individual correlation. Eur Spine J. 2012 Aug;21 Suppl 6(Suppl 6):S810-8. doi: 10.1007/s00586-011-1922-3. Epub 2011 Aug 12.
PubMed 21837413Christe A, Laubli R, Guzman R, Berlemann U, Moore RJ, Schroth G, Vock P, Lovblad KO. Degeneration of the cervical disc: histology compared with radiography and magnetic resonance imaging. Neuroradiology. 2005 Oct;47(10):721-9. doi: 10.1007/s00234-005-1412-6. Epub 2005 Sep 1.
PubMed 16136264Czaprowski D, Stolinski L, Tyrakowski M, Kozinoga M, Kotwicki T. Non-structural misalignments of body posture in the sagittal plane. Scoliosis Spinal Disord. 2018 Mar 5;13:6. doi: 10.1186/s13013-018-0151-5. eCollection 2018.
PubMed 29516039Pausic J, Pedisic Z, Dizdar D. Reliability of a photographic method for assessing standing posture of elementary school students. J Manipulative Physiol Ther. 2010 Jul-Aug;33(6):425-31. doi: 10.1016/j.jmpt.2010.06.002.
PubMed 20732579
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postural Reconstruction on the Functionality of the Cervical Region
- ClinicalTrials.gov ID
- NCT04299672
- Acronym / sponsor ID
- CERFUPOS / PR_Cervical
- Keywords
- Cervical pain, Funcionality, Posture, Balance, Muscular tone, Postural reconstruction, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Antonio de NebrijaUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- -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/)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group
| Arm | Type | Receives |
|---|---|---|
| Postural reconstruction | Experimental | Procedure: Postural reconstructionMaximum 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postural reconstructionInterventions are described in group descriptions | Procedure or surgery | Postural reconstruction |
Primary outcome
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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)
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).
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Background: PubMed 15999284Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
- Background: PubMed 29652782Sempere-Rubio N, Aguilar-Rodriguez M, Espi-Lopez GV, Cortes-Amador S, Pascual E, Serra-Ano P. Impaired Trunk Posture in Women With Fibromyalgia. Spine (Phila Pa 1976). 2018 Nov 15;43(22):1536-1542. doi: 10.1097/BRS.0000000000002681.
- Background: PubMed 27821964Kim EK, Kim JS. Correlation between rounded shoulder posture, neck disability indices, and degree of forward head posture. J Phys Ther Sci. 2016 Oct;28(10):2929-2932. doi: 10.1589/jpts.28.2929. Epub 2016 Oct 28.
- Background: PubMed 26957772Kim JY, Kwag KI. Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain. J Phys Ther Sci. 2016 Jan;28(1):269-73. doi: 10.1589/jpts.28.269. Epub 2016 Jan 30.
- Background: PubMed 1589462Griegel-Morris P, Larson K, Mueller-Klaus K, Oatis CA. Incidence of common postural abnormalities in the cervical, shoulder, and thoracic regions and their association with pain in two age groups of healthy subjects. Phys Ther. 1992 Jun;72(6):425-31. doi: 10.1093/ptj/72.6.425.
- Background: PubMed 27149581Ferracini GN, Chaves TC, Dach F, Bevilaqua-Grossi D, Fernandez-de-Las-Penas C, Speciali JG. Relationship Between Active Trigger Points and Head/Neck Posture in Patients with Migraine. Am J Phys Med Rehabil. 2016 Nov;95(11):831-839. doi: 10.1097/PHM.0000000000000510.
- Background: PubMed 26429723Malmstrom EM, Olsson J, Baldetorp J, Fransson PA. A slouched body posture decreases arm mobility and changes muscle recruitment in the neck and shoulder region. Eur J Appl Physiol. 2015 Dec;115(12):2491-503. doi: 10.1007/s00421-015-3257-y. Epub 2015 Oct 1.
- Background: PubMed 25025491Janda V. On the concept of postural muscles and posture in man. Aust J Physiother. 1983 Jun;29(3):83-4. doi: 10.1016/S0004-9514(14)60665-6.
- Background: PubMed 26281953Wilke J, Krause F, Vogt L, Banzer W. What Is Evidence-Based About Myofascial Chains: A Systematic Review. Arch Phys Med Rehabil. 2016 Mar;97(3):454-61. doi: 10.1016/j.apmr.2015.07.023. Epub 2015 Aug 14.
- Background: PubMed 27001027Krause F, Wilke J, Vogt L, Banzer W. Intermuscular force transmission along myofascial chains: a systematic review. J Anat. 2016 Jun;228(6):910-8. doi: 10.1111/joa.12464. Epub 2016 Mar 22.
- Background: PubMed 23541175Destieux C, Gaudreault N, Isner-Horobeti ME, Vautravers P. Use of Postural Reconstruction(R) physiotherapy to treat an adolescent with asymmetric bilateral genu varum and idiopathic scoliosis. Ann Phys Rehabil Med. 2013 May;56(4):312-26. doi: 10.1016/j.rehab.2013.02.004. Epub 2013 Mar 20.
- Background: PubMed 21837413Weiler C, Schietzsch M, Kirchner T, Nerlich AG, Boos N, Wuertz K. Age-related changes in human cervical, thoracal and lumbar intervertebral disc exhibit a strong intra-individual correlation. Eur Spine J. 2012 Aug;21 Suppl 6(Suppl 6):S810-8. doi: 10.1007/s00586-011-1922-3. Epub 2011 Aug 12.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postural reconstruction in people with People With Impaired Motor Function in the Cervical Region, run by Universidad Antonio de Nebrija at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04299672, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.