Specific Effect of Foot Reflexology on Diaphragm Function (FOOT)

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

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Manipulations
• Intervention / Treatment: Other: reflexology massage; Other: sham massage

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emeline DESCAMPS; Phone Number: 0562746187; Email: emeline.descamps@inserm.fr

Study Locations

• France
  • Toulouse, France
    • PAYOUX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Pierre PAYOUX, PD PhD, Uh Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: reflexology; diaphragm dysfunction
• Other Study ID Numbers: RC31/20/0251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No