Specific Effect of Foot Reflexology on Diaphragm Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Musculoskeletal Manipulations

Intervention / Treatment
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* Other: reflexology massage
* Other: sham massage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: monocentric, interventional, comparative, randomized cross-over study in healthy individuals, with minimal risk and constraints
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sham massage before reflexology massage (RP)<br>Sham massage (MS) comparator will be realised before RP. | Other: reflexology massage<br>* reflexology massage of the foot zone implicated in diaphragm stimulation<br>Other: sham massage<br>* traditional massage of the foot<br>|
| Other: Reflexology massage (RP) before Sham massage<br>RP will be realized before Sham massage. | Other: reflexology massage<br>* reflexology massage of the foot zone implicated in diaphragm stimulation<br>Other: sham massage<br>* traditional massage of the foot<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of physiological constants related to the function of the diaphragm | collection of respiratory rate | Day 1 | 
| variation of physiological constants related to the function of the diaphragm | collection of saturation | Day 1 | 
| variation in physiological constants linked to the ANS | collection of heart rate | Day 1 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diaphragm dysfunction, reflexology