NCT04404829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2020

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

21 days

First QC Date

May 17, 2020

Last Update Submit

November 2, 2020

Conditions

Keywords

balancepainquality of lifemanual therapy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (16)

  • How much bodily pain have you had during the past 4 weeks?

    baseline, pre-intervention

  • How much bodily pain have you had during the past 4 weeks?

    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)?

    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)?

    three weeks after treatment

  • mobility

    baseline, pre-intervention

  • +11 more secondary outcomes

Study Arms (1)

Informational Manual Therapy

EXPERIMENTAL

It is an integral no orthopedic and very soft manual therapy

Other: Manual Therapy

Interventions

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.

Also known as: Poyet-Pialoux method
Informational Manual Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy people

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Barcelona, Catalonia, 08195, Spain

Location

Related Publications (6)

  • 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.

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

  • 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.

  • 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.

  • Frymann VM. A study of the rhythmic motions of the living cranium. J Am Osteopath Assoc. 1971 May;70(9):928-45. No abstract available.

  • Ballester-Rodes M, Carreras-Costa F, Versyp-Ducaju T, Ballester-Rodes 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.2019.02.012. Epub 2019 Feb 2.

Related Links

MeSH Terms

Conditions

Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Rosa Cabanas Valdés, PhD

    Universitat Internacional de Catalunya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study has a one-group pretest-posttest design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Universitat Internacional de Catalunya

Study Record Dates

First Submitted

May 17, 2020

First Posted

May 28, 2020

Study Start

May 1, 2020

Primary Completion

May 22, 2020

Study Completion

June 15, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

There is not any plan

Locations