Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04404829
Other study ID # Poyet-Pialoux method
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date June 15, 2020

Study information

Verified date November 2020
Source Universitat Internacional de Catalunya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objectives: The aim of this study is to assess the effect of Informational Manual Therapy (IMT) on quiet standing and quality of life in healthy individuals. The IMT also is known as the Poyet-Pialoux method, is a holistic, no orthopedic, and soft manual therapy. Design: This is a one-group pretest-posttest design. It is a within-subjects experiment in which each participant is tested first under the control condition and then under the treatment condition. Setting: University laboratory. Intervention: One IMT session was performed on 57 healthy individuals aged from 18 to 65 years. They were grouped into three age groups. The treatment session was performed by 5 therapists on two days. The primary outcome was quite standing assessed by the SATEL force platform. Secondary outcomes were bodily pain assessed by the pain sections of the 36-Item Short Form Survey (SF-36) and quality of life by EQ-5D-3L (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The primary outcome was evaluated before and immediately after treatment and after 7-10 days. The secondary outcomes were assessed after treatment and 3 weeks later.


Description:

Methods Study Design: The study has a one-group pretest-posttest design. The personal data of individuals were kept confidential and the data were shared anonymously upon request from the principal researcher. The TREND statement will be followed. Subjects Fifty-seven participants will be recruited to participate in this study; the sample was one of convenience. The inclusion and exclusion criteria are as follows: age from 18 to 65 years old, not having a positive diagnosis for any disease which influences balance, no participation in any other trial, not suffering from an injury in the 3 months before the study or fractures in the previous 6 months, and no falls in the previous month. All individuals provided informed consent before enrolment. Intervention All the participants received a single session of 30-45 min of IMT. All the treatment sessions took place at the UIC laboratory. The IMT session was performed over two days by four physiotherapists and a doctor. All have more than five years of experience in IMT treatment. The first level of IMT was treated in this study: the objective is to harmonize the Cranio-sacral and sacro-pelvic systems, as this is fundamental for maintaining good posture. The first therapeutic maneuvers should be focused on releasing of the sacrum and the pelvis. The first is considered a key area for the correct transmission of forces and loads from the lower limbs to the upper limbs and vice versa and shares the role of rigid elements for this purpose (bones) and tensile elements (muscles, ligaments, fascia) in the whole body. At this level. Compensatory injuries that the body has started after a primary injury are treated on this level, through the Fluidic Chains. This also includes the treatment of some traumatic injuries, such as cranial strains, the compression of spheno-basilar synchondrosis, injuries of the pelvis and occipital bone, and damage to the flexion-extension and lateral displacement of the vertebrae. The diagnosis of this level is performed by cranial somotopias (reflex points on the skull and face). Practically all the treatment is carried out on the sacrum. The first step is the "fuses," which are vibration zones that act as a protection system for the body (1). These points sometimes stop working, which interrupts the correct movement of the PRM: 1st fuse: Inn-trang (on the forehead between the two eyebrows, the 4th sacral vertebra is stimulated if it is not adjusted). A massage on the scalp in several very soft circles that goes from the frontal to the occipital area is performed 6 times. 2nd fuse: 1st dorsal vertebra, 4th cervical, 4th dorsal, and 3rd lumbar. 3rd fuse: C0 (base of the occipital), a zone of the 2nd sacral vertebra, and the space between the spines of the 2nd and 3rd dorsal vertebrae and finally point R1 (between the 2nd and 3 rd metatarsal). If any point is blocked it is treated and harmonized with a soft touch towards the occipital.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date June 15, 2020
Est. primary completion date May 22, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Healthy people Exclusion Criteria: Not having problems with balance, Not suffering from an injury in the 3 months before the study, Not suffering from a fracture in the previous 6 month before the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Manual Therapy
The first level of IMT was treated in this study: the objective is to harmonize the cranio-sacral and sacro-pelvic systems, as this is fundamental for maintaining good posture. The first therapeutic maneuvers should be focused on releasing of the sacrum and the pelvis. The first is considered a key area for the correct transmission of forces and loads from the lower limbs to the upper limbs and vice versa and shares the role of rigid elements for this purpose (bones) and tensile elements (muscles, ligaments, fascia) in the whole body. In this level. Compensatory injuries that the body has started after a primary injury are treated on this level, through the Fluidic Chains. The diagnosis of this level is performed by cranial somotopias. Practically all the treatment is carried out on the sacrum. The first step are the "fuses," which are vibration zones which act as a protection system for the body. These points sometimes stop working, which interrupts the correct movement of the PRM.

Locations

Country Name City State
Spain Universitat Internacional de Catalunya Barcelona Catalonia

Sponsors (1)

Lead Sponsor Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Ballester-Rodés M, Carreras-Costa F, Versyp-Ducaju T, Ballester-Rodés M, Mehta D. Field dynamics in atrioventricular activation. Clinical evidence of a specific field-to-protein interaction. Med Hypotheses. 2019 Mar;124:56-59. doi: 10.1016/j.mehy.2019.02. — View Citation

Bordoni B, Zanier E. Sutherland's legacy in the new millennium: the osteopathic cranial model and modern osteopathy. Adv Mind Body Med. 2015 Spring;29(2):15-21. Review. — View Citation

Frymann VM. A study of the rhythmic motions of the living cranium. J Am Osteopath Assoc. 1971 May;70(9):928-45. — View Citation

Lee RP. The living matrix: a model for the primary respiratory mechanism. Explore (NY). 2008 Nov-Dec;4(6):374-8. doi: 10.1016/j.explore.2008.08.003. Review. — View Citation

Liem T, Neuhuber W. Osteopathic Treatment Approach to Psychoemotional Trauma by Means of Bifocal Integration. J Am Osteopath Assoc. 2020 Mar 1;120(3):180-189. doi: 10.7556/jaoa.2020.021. — View Citation

Tseui JJ. Eastern and western approaches to medicine. West J Med. 1978 Jun;128(6):551-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary static standing posture It was assessed using the force platform Satel 40 Hz model PF2002, software v 33.5 8C (France). baseline, pre-intervention
Primary static standing posture It was assessed using the force platform Satel 40 Hz model PF2002, software v 33.5 8C (France). immediately after the intervention
Secondary How much bodily pain have you had during the past 4 weeks? by the 36-Item Short Form Survey (SF-36). 1 - None,2 - Very mild,3 - Mild, 4 - Moderate, 5 - Severe, - 6 very severe baseline, pre-intervention
Secondary How much bodily pain have you had during the past 4 weeks? by the 36-Item Short Form Survey (SF-36). 1 - None,2 - Very mild,3 - Mild, 4 - Moderate, 5 - Severe, - 6 very severe three weeks, post-intervention
Secondary During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)? by the 36-Item Short Form Survey (SF-36). 1 - Not at all, 2 - A little bit, 3 - Moderately, 4 - Quite a bit, 5 - Extremely baseline, pre-intervention
Secondary During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)? by the 36-Item Short Form Survey (SF-36). 1 - Not at all, 2 - A little bit, 3 - Moderately, 4 - Quite a bit, 5 - Extremely three weeks after treatment
Secondary mobility by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems baseline, pre-intervention
Secondary mobility by the EQ-5D-3L questionnaire.Each dimension has 3 levels: no problems, some problems, and extreme problems three weeks post-intervention
Secondary self-care by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems baseline, pre-intervention
Secondary self-care by the EQ-5D-3L questionnaire.Each dimension has 3 levels: no problems, some problems, and extreme problems three weeks post-intervention
Secondary usual activities by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems baseline, pre-intervention
Secondary usual activities by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems three weeks post-intervention
Secondary pain/discomfort by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems baseline, pre-intervention
Secondary pain/discomfort by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems three weeks post-intervention
Secondary anxiety/depression by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems baseline, pre-intervention
Secondary anxiety/depression by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems three weeks post-intervention
Secondary visual analogue scale for health by the EQ-VAS, ranging from 0 ("worst possible") to 100 ("best possible"). baseline, pre-intervention
Secondary visual analogue scale for health by the EQ-VAS, ranging from 0 ("worst possible") to 100 ("best possible"). three weeks post-intervention
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care