Informational Manual Therapy to Improve Standing Balance

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of the Informational Manual Therapy for Improving Quiet Standing, Pain and Quality of Life in Healthy Individuals

Conditions
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Balance Postural, Pain, Quality of Life

Intervention / Treatment
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* Other: Manual Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study has a one-group pretest-posttest design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Informational Manual Therapy<br>It is an integral no orthopedic and very soft manual therapy | Other: Manual Therapy<br>* 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.<br>* Other names: Poyet-Pialoux method;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| static standing posture | It was assessed using the force platform Satel 40 Hz model PF2002, software v 33.5 8C (France). | baseline, pre-intervention | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| mobility | by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems | baseline, pre-intervention | 
| mobility | by the EQ-5D-3L questionnaire.Each dimension has 3 levels: no problems, some problems, and extreme problems | three weeks post-intervention | 
| self-care | by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems | baseline, pre-intervention | 
| self-care | by the EQ-5D-3L questionnaire.Each dimension has 3 levels: no problems, some problems, and extreme problems | three weeks post-intervention | 
| usual activities | by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems | baseline, pre-intervention | 
| usual activities | by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems | three weeks post-intervention | 
| pain/discomfort | by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems | baseline, pre-intervention | 
| pain/discomfort | by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems | three weeks post-intervention | 
| anxiety/depression | by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems | baseline, pre-intervention | 
| anxiety/depression | by the EQ-5D-3L questionnaire. Each dimension has 3 levels: no problems, some problems, and extreme problems | three weeks post-intervention | 
| visual analogue scale for health | by the EQ-VAS, ranging from 0 (worst possible) to 100 (best possible). | baseline, pre-intervention | 
| visual analogue scale for health | by the EQ-VAS, ranging from 0 (worst possible) to 100 (best possible). | three weeks post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balance, pain, quality of life, manual therapy