Specific Effect of Foot Reflexology on Diaphragm Function

Musculoskeletal Manipulations Clinical Trial

— FOOT  

Official title:

Specific Effect of Foot Reflexology on Diaphragm Function: Comparison Between Different Biomarkers Upon Stimulation of the Reflex Area

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04661774
• Other study ID #: RC31/20/0251
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diaphragm dysfunction, are refractory to drug therapy. This encourage investigators to explore new non-drug therapeutic paths, such as plantar reflexology (RP). The investigators proposed a comparison of the evolution of different parameters, quantitative and qualitative, to identify biomarkers and highlight the specific effect of RP on the diaphragm function, compared to placebo.

Description:

Many complex, chronic and multifactorial dysfunctions, such as diaphragm dysfunction, are refractory to drug therapy. This encourage investigators to explore new non-drug therapeutic paths, such as plantar reflexology (RP). This change is essential and will broaden relevant solutions to health.

Despite the very positive benefits of RP highlighted, the methodological quality of trials are often poor and there are gaps notably on the description of the intervention, the blind, the drop-out rate ... which prevents the meta-analyzes to conclude. Promoting rigorous research will play an essential role in the transition to personalized and integrative medicine. With the intention of specifying the methods of application and the indications of the PR, it is necessary to correctly evaluate and be able to cross-check the different information It therefore seems relevant to combine research on the objective physiological effects in correlation with the patient's subjective feelings to initiate the scientific validation of RP and thus non-drug interventions as recommended by the High Authority for Health (HAS). The hypothesis is that through a comparison of the evolution of different parameters, quantitative and qualitative, this study will allow to identify biomarkers and highlight the specific effect of RP on the diaphragm function, compared to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Adult aged 20 to 40

• Healthy right-handed subject, attested by a score = 8/10 on the Edinburgh manual laterality questionnaire

• Naive subject in Reflexology.

Exclusion Criteria:

• Contraindication to carrying out the MRI examination

• Subject refusing to be informed of any abnormality detected on brain MRI,

• Subject presenting a neurodegenerative disease,

• Subject presenting a cardiac disease,

• Subject presenting skin lesions in the feet or recent fracture in the feet,

• Subject having an history of phlebitis less than 3 months

• Subject having an history of deep vein thrombosis.

Related Conditions & MeSH terms

• Musculoskeletal Manipulations

Intervention

Other:
• reflexology massage
reflexology massage of the foot zone implicated in diaphragm stimulation
• sham massage
traditional massage of the foot

Locations

Country	Name	City	State
France	PAYOUX	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modulation of brain activity of the specific impact of RP	a comparison between the activation cards of the brain networks and a map of correlation coefficients representing the strength of the connectivity between the different brain networks and regions of interest	day 1
Secondary	variation of physiological constants related to the function of the diaphragm	collection of respiratory rate	Day 1
Secondary	variation of physiological constants related to the function of the diaphragm	collection of saturation	Day 1
Secondary	variation in physiological constants linked to the ANS	collection of heart rate	Day 1
Secondary	subjective feelings of the subjects	Likert scale for the subjective assessment of stress and a Likert scale for the subjective assessment of ease of breathing (graduations from 1 to 7 with 1 = I completely agree and 7= I Don't agree at all)	Day 1