Musculoskeletal ManipulationsFOOTNCT04661774
Specific Effect of Foot Reflexology on Diaphragm Function
A study testing reflexology massage in people with Musculoskeletal Manipulations, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Manipulations
- What is being tested?
- reflexology massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Musculoskeletal Manipulations
- Being tested
- reflexology massage, sham massage
- Keywords
- diaphragm dysfunction, reflexology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reflexology massageOther
reflexology massage of the foot zone implicated in diaphragm stimulation
sham massageOther
traditional massage of the foot
| Study group | Role | What they receive |
|---|---|---|
| Sham massage before reflexology massage (RP) | Other | Sham massage (MS) comparator will be realised before RP. Receives: Other: reflexology massage; Other: sham massage |
| Reflexology massage (RP) before Sham massage | Other | RP will be realized before Sham massage. Receives: Other: reflexology massage; Other: sham massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Secondary outcomes (4)
variation of physiological constants related to the function of the diaphragm
collection of respiratory rate
Measured: Day 1
variation of physiological constants related to the function of the diaphragm
collection of saturation
Measured: Day 1
variation in physiological constants linked to the ANS
collection of heart rate
Measured: 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)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Dec 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal ManipulationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- monocentric, interventional, comparative, randomized cross-over study in healthy individuals, with minimal risk and constraints
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661774
- Sponsor's protocol ID
- RC31/20/0251
- Acronym
- FOOT
- Status last verified
- Aug 2023
- First submitted
- 6 Nov 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Descamps E, Boussac M, Joineau K, Payoux P. Changes of cerebral functional connectivity induced by foot reflexology in a RCT. Sci Rep. 2023 Oct 10;13(1):17139. doi: 10.1038/s41598-023-44325-x.
PubMed 37816799
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Effect of Foot Reflexology on Diaphragm Function: Comparison Between Different Biomarkers Upon Stimulation of the Reflex Area
- ClinicalTrials.gov ID
- NCT04661774
- Acronym / sponsor ID
- FOOT / RC31/20/0251
- Conditions
- Musculoskeletal Manipulations
- Keywords
- diaphragm dysfunction, reflexology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- monocentric, interventional, comparative, randomized cross-over study in healthy individuals, with minimal risk and constraints
| Arm | Type | Receives |
|---|---|---|
| Sham massage before reflexology massage (RP) | Other | Other: reflexology massage, Other: sham massageSham massage (MS) comparator will be realised before RP. |
| Reflexology massage (RP) before Sham massage | Other | Other: reflexology massage, Other: sham massageRP will be realized before Sham massage. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reflexology massagereflexology massage of the foot zone implicated in diaphragm stimulation | Other | Reflexology massage (RP) before Sham massage, Sham massage before reflexology massage (RP) |
| sham massagetraditional massage of the foot | Other | Reflexology massage (RP) before Sham massage, Sham massage before reflexology massage (RP) |
Primary outcome
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
4 secondary outcomes
variation of physiological constants related to the function of the diaphragm
Time frame: Day 1
variation of physiological constants related to the function of the diaphragm
Time frame: Day 1
variation in physiological constants linked to the ANS
Time frame: Day 1
subjective feelings of the subjects
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 37816799Descamps E, Boussac M, Joineau K, Payoux P. Changes of cerebral functional connectivity induced by foot reflexology in a RCT. Sci Rep. 2023 Oct 10;13(1):17139. doi: 10.1038/s41598-023-44325-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reflexology massage in people with Musculoskeletal Manipulations, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modulation of brain activity of the specific impact of RP (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04661774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.