Specific Effect of Foot Reflexology on Diaphragm Function

Not Applicable

Completed

• Conditions: Musculoskeletal Manipulations
• Interventions: Other: reflexology massage; Other: sham massage

• Registration Number: NCT04661774
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

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 Timeline

• Study First Submitted: 2020-11-06
• Study Start: 2020-12-01
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham massage before reflexology massage (RP)	sham massage	Sham massage (MS) comparator will be realised before RP.
Reflexology massage (RP) before Sham massage	sham massage	RP will be realized before Sham massage.
Sham massage before reflexology massage (RP)	reflexology massage	Sham massage (MS) comparator will be realised before RP.
Reflexology massage (RP) before Sham massage	reflexology massage	RP will be realized before Sham massage.

Primary Outcome Measures

Name	Time	Method
modulation of brain activity of the specific impact of RP	day 1	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

Secondary Outcome Measures

Name	Time	Method
variation of physiological constants related to the function of the diaphragm	Day 1	collection of saturation
variation in physiological constants linked to the ANS	Day 1	collection of heart rate
subjective feelings of the subjects	Day 1	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)

Trial Locations

Locations (1)

PAYOUX; 🇫🇷 Toulouse, France