Clinical trial NCT04404829: Informational Manual Therapy to Improve Standing Balance
Official title: The Effect of the Informational Manual Therapy for Improving Quiet Standing, Pain and Quality of Life in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance Postural
Pain
Quality of Life
Keywords: balance
pain
quality of life
manual therapy
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study has a one-group pretest-posttest design.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: static standing posture
timeFrame: baseline, pre-intervention
measure: static standing posture
timeFrame: immediately after the intervention
Secondary outcomes:
measure: How much bodily pain have you had during the past 4 weeks?
timeFrame: baseline, pre-intervention
measure: How much bodily pain have you had during the past 4 weeks?
timeFrame: three weeks, post-intervention
measure: During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
timeFrame: baseline, pre-intervention
measure: During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
timeFrame: three weeks after treatment
measure: mobility
timeFrame: baseline, pre-intervention
measure: mobility
timeFrame: three weeks post-intervention
measure: self-care
timeFrame: baseline, pre-intervention
measure: self-care
timeFrame: three weeks post-intervention
measure: usual activities
timeFrame: baseline, pre-intervention
measure: usual activities
timeFrame: three weeks post-intervention
measure: pain/discomfort
timeFrame: baseline, pre-intervention
measure: pain/discomfort
timeFrame: three weeks post-intervention
measure: anxiety/depression
timeFrame: baseline, pre-intervention
measure: anxiety/depression
timeFrame: three weeks post-intervention
measure: visual analogue scale for health
timeFrame: baseline, pre-intervention
measure: visual analogue scale for health
timeFrame: three weeks post-intervention
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universitat Internacional de Catalunya
state: Catalonia
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Rosa Cabanas Valdés, PhD
role: PRINCIPAL_INVESTIGATOR
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