People With Impaired Motor Function in the Cervical Region Clinical Trial
— CERFUPOSOfficial title:
Effect of Postural Reconstruction on the Functionality of the Cervical Region
| Verified date | September 2021 |
| Source | Universidad Antonio de Nebrija |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | March 20, 2021 |
| Est. primary completion date | March 20, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | José Ríos-Díaz | Madrid | Comunidad De Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad Antonio de Nebrija |
Spain,
Cernean N, Serranheira F, Gonçalves P, Sá Dos Reis C. Ergonomic strategies to improve radiographers' posture during mammography activities. Insights Imaging. 2017 Aug;8(4):429-438. doi: 10.1007/s13244-017-0560-7. Epub 2017 Jun 21. — View Citation
Christe A, Läubli R, Guzman R, Berlemann U, Moore RJ, Schroth G, Vock P, Lövblad KO. Degeneration of the cervical disc: histology compared with radiography and magnetic resonance imaging. Neuroradiology. 2005 Oct;47(10):721-9. Epub 2005 Sep 1. — View Citation
Czaprowski 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. Review. — View Citation
Destieux C, Gaudreault N, Isner-Horobeti ME, Vautravers P. Use of Postural Reconstruction® 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. — View Citation
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. Epub 2005 Jul 6. Review. — View Citation
Ferracini GN, Chaves TC, Dach F, Bevilaqua-Grossi D, Fernández-de-Las-Peñas 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. — View Citation
Fortin C, Feldman DE, Cheriet F, Labelle H. Clinical methods for quantifying body segment posture: a literature review. Disabil Rehabil. 2011;33(5):367-83. doi: 10.3109/09638288.2010.492066. Epub 2010 Jun 23. Review. — View Citation
Griegel-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. — View Citation
Guan X, Fan G, Wu X, Zeng Y, Su H, Gu G, Zhou Q, Gu X, Zhang H, He S. Photographic measurement of head and cervical posture when viewing mobile phone: a pilot study. Eur Spine J. 2015 Dec;24(12):2892-8. doi: 10.1007/s00586-015-4143-3. Epub 2015 Jul 24. — View Citation
Janda 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. — View Citation
Kim 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. Epub 2016 Oct 28. — View Citation
Kim 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. — View Citation
Kovacs FM, Bagó J, Royuela A, Seco J, Giménez S, Muriel A, Abraira V, Martín JL, Peña JL, Gestoso M, Mufraggi N, Núñez M, Corcoll J, Gómez-Ochoa I, Ramírez MJ, Calvo E, Castillo MD, Martí D, Fuster S, Fernández C, Gimeno N, Carballo A, Milán A, Vázquez D, — View Citation
Krause 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. Review. — View Citation
Luomajoki H, Kool J, de Bruin ED, Airaksinen O. Movement control tests of the low back; evaluation of the difference between patients with low back pain and healthy controls. BMC Musculoskelet Disord. 2008 Dec 24;9:170. doi: 10.1186/1471-2474-9-170. — View Citation
Malmström 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. — View Citation
Pausic 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. — View Citation
Revel M, Andre-Deshays C, Minguet M. Cervicocephalic kinesthetic sensibility in patients with cervical pain. Arch Phys Med Rehabil. 1991 Apr;72(5):288-91. — View Citation
Roren A, Mayoux-Benhamou MA, Fayad F, Poiraudeau S, Lantz D, Revel M. Comparison of visual and ultrasound based techniques to measure head repositioning in healthy and neck-pain subjects. Man Ther. 2009 Jun;14(3):270-7. doi: 10.1016/j.math.2008.03.002. Ep — View Citation
Rosário JL. Biomechanical assessment of human posture: a literature review. J Bodyw Mov Ther. 2014 Jul;18(3):368-73. doi: 10.1016/j.jbmt.2013.11.018. Epub 2013 Nov 27. Review. — View Citation
Segarra V, Dueñas L, Torres R, Falla D, Jull G, Lluch E. Inter-and intra-tester reliability of a battery of cervical movement control dysfunction tests. Man Ther. 2015 Aug;20(4):570-9. doi: 10.1016/j.math.2015.01.007. Epub 2015 Jan 26. — View Citation
Sempere-Rubio N, Aguilar-Rodríguez M, Espí-López GV, Cortés-Amador S, Pascual E, Serra-Añó P. Impaired Trunk Posture in Women With Fibromyalgia. Spine (Phila Pa 1976). 2018 Nov 15;43(22):1536-1542. doi: 10.1097/BRS.0000000000002681. — View Citation
Weiler 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:S810-8. doi: 10.1007/s00586-011-1922-3. Epub 2011 Aug 12. — View Citation
Wilke 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. Review. — View Citation
Young IA, Dunning J, Butts R, Cleland JA, Fernández-de-Las-Peñas C. Psychometric properties of the Numeric Pain Rating Scale and Neck Disability Index in patients with cervicogenic headache. Cephalalgia. 2019 Jan;39(1):44-51. doi: 10.1177/0333102418772584 — View Citation
* Note: There are 25 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 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 | |
| Primary | 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. | 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 | |
| Primary | 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. | 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 | |
| Primary | 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. | 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 | |
| Primary | 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. | 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 | |
| Primary | 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 | 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 | |
| Primary | 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. | 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 | |
| Primary | 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. | 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 | |
| Primary | 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. | 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 | |
| Primary | 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. | 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 | |
| Primary | Change in Rear balancing on 4 supports test | 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 | |
| Primary | 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) | 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 | |
| Primary | Change in Cervical pain | 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 | Change in Cervical Flexion | 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 | |
| Secondary | Change in Cervical Extension | 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 | |
| Secondary | Change in Cervical Inclination | 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 | |
| Secondary | Change in Cervical Rotation | 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 |