Informational Manual Therapy to Improve Standing Balance

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04404829
• Other study ID #: Poyet-Pialoux method
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Balance Postural
• Pain
• Quality of Life

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

External Links

•   Ostéopathie non structurelle ; à l'écoute du corps, une évolution de la méthode Poyet