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Specific Effect of Foot Reflexology on Diaphragm Function (FOOT)

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ClinicalTrials.gov Identifier: NCT04661774
Recruitment Status : Not yet recruiting
First Posted : December 10, 2020
Last Update Posted : December 10, 2020
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Manipulations Other: reflexology massage Other: sham massage Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: monocentric, interventional, comparative, randomized cross-over study in healthy individuals, with minimal risk and constraints
Masking: Single (Participant)
Masking Description: each participant has reflexology and placebo massage, he is his own comparator
Primary Purpose: Other
Official Title: Specific Effect of Foot Reflexology on Diaphragm Function: Comparison Between Different Biomarkers Upon Stimulation of the Reflex Area
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. modulation of brain activity of the specific impact of RP [ Time Frame: 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 :
  1. variation of physiological constants related to the function of the diaphragm [ Time Frame: Day 1 ]
    collection of respiratory rate

  2. variation of physiological constants related to the function of the diaphragm [ Time Frame: Day 1 ]
    collection of saturation

  3. variation in physiological constants linked to the ANS [ Time Frame: Day 1 ]
    collection of heart rate

  4. subjective feelings of the subjects [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661774


Contacts
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Contact: Emeline DESCAMPS 0562746187 emeline.descamps@inserm.fr

Sponsors and Collaborators
University Hospital, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Pierre PAYOUX, PD PhD UH Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04661774    
Other Study ID Numbers: RC31/20/0251
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
diaphragm dysfunction
reflexology