Parkinson DiseaseDOREPARNCT04705207
Foot Reflexology on Chronic Pain in Parkinsonian Patients
A study testing reflexology massage in people with Parkinson Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Pain is one of the non-motor symptoms of Parkinson's disease still poorly known and misdiagnosed and its management is complex. This encourage to explore new non-drug therapeutic paths, such as foot reflexology (FR). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- reflexology massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2021to 25 May 2023
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with an age egal at 18 years old or more,
- Patient presenting a little fluctuating Parkinson's disease attested by a score ≤ 2 on the MDS UPDRS IV,
- Patients with chronic pain for at least 3 months with a VAS ≥ 4
- Patients whose anti-parkinsonian treatment is stable throughout the duration of the study and at least for 4 weeks.
Who cannot join
- Patients with cognitive impairment defined by an MOCA<25
- Patient presenting contraindication to carrying out the MRI examination
- Patient refusing to be informed of any abnormality detected on brain MRI
- Patient included in a clinical trial that potentially interferes with the objective of the study,
- Patient resistant to foot massage,
- Patient having benefited from a Foot reflexology session in the last 6 months, - Patient presenting skin lesions in the feet,
- Patient having a recent fracture in the feet,
- Patient having an history of phlebitis less than 3 months and history of deep vein thrombosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study of the Impact of Foot Reflexology on Chronic Pain in Parkinsonian Patients
Pain is one of the non-motor symptoms of Parkinson's disease still poorly known and misdiagnosed and its management is complex. This encourage to explore new non-drug therapeutic paths, such as foot reflexology (FR). the present study proposed a comparison of the evolution of different parameters, quantitative and qualitative, to identify biomarkers and highlight the specific effect of FR on pain, compared to sham massage.
Read the detailed description
Parkinson's disease (PD) is a neurodegenerative disease characterized by the destruction of specific neurons population involved in movement control. Pain is one of the non-motor symptoms still poorly known and misdiagnosed. In addition to this fact, its management is complex. At present, the medical community has no effective solution to reduce pain to an acceptable level in terms of intensity or frequency.
Pain is a personal, subjective experience with an affective and cognitive dimension. The context and its psychological impact can amplify as well as alleviate the pain. Thus, non-pharmacological treatment (NPT) that influence the psychological state (mood, level of stress, ...) can also modulate the pain experience through the brain matrix of pain. Among them, foot reflexology, which by stimulating reflex zones located on the feet, makes it possible to modify the perception of the pain and to modify the subjective / emotional valence of the pain. In this study, we propose to evaluate this technique, by postulating that it should reduce the chronic pain of patients with Parkinson's disease.
This project is innovative and original in two dimensions : On the one hand, the pain of patients in PD is still often underestimated, there is in the mere fact of devoting a study a real dynamic of change in the consideration of the patients concerned and in the management of this non-motor symptom. On the other hand, the increasing use of NPT requires that clinical studies be conducted. To date, it is clear that very few or no reliable studies have been conducted on the subject. We wish to develop complementary non-pharmacological management to provide concrete help to Parkinson's patients and thus initiate the scientific validation of NPT as recommended by the High Authority of Health.
The study hypothesize 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 FR on pain, compared to sham massage.
- Conditions
- Parkinson Disease
- Being tested
- reflexology massage, sham massage
- Keywords
- Pain, Foot Reflexology
- Medical subject headings
- Parkinson Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reflexology massageProcedure or surgery
the patient receive only foot reflexology massage
sham massageProcedure or surgery
the patient receive only foot traditional massage
| Study group | Role | What they receive |
|---|---|---|
| reflexology massage | Experimental | foot reflexology massage Receives: Procedure: reflexology massage |
| sham massage | Placebo comparator | traditional foot massage Receives: Procedure: sham massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of changes in the mean intensity of chronic pain
Visual Analog Scale (VAS) ok pain (0 is no pain, 10 is the most high pain)
Measured: Day 1 and week 12
Secondary outcomes (8)
evaluation of the change in pain on the VAS
Visual Analog Scale of change of pain (0 is no pain, 10 is the most high pain)
Measured: Day 1, week 3, week 6, week 9 and week 12
evaluation of change in chronic pain
King's Parkinson's disease Pain Scale (KPPS)
Measured: Day 1 and week 12
evaluation of change in chronic pain
Brief Pain Inventory (BPI)
Measured: Day 1 and week 12
evaluation of change in chronic pain
Primary Parkinsonian Pain Diagnostic Questionnaire (3PDQ)
Measured: Day 1 and week 12
evaluation of the consumption of analgesics
completion by the patient of a logbook of analgesic treatments
Measured: Day 1, week 3, week 6, week 9 and week 12
evaluation of anxiety and depression
Hospital Anxiety Depression (HAD) scale
Measured: Day 1 and week 12
connectivity of brain networks
observation of connectivity cards by Functional Magnetic Resonance Imaging (MRI)
Measured: Day 1 and week 12
evaluation of the threshold of perception of subjective warm pain
contact thermode is used to dermine the threshold of perception
Measured: Day 1, week 9 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start14 Apr 2021
- Primary completion25 May 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a group has intervention, a group has placebo intervention
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine BREFEL-COURBON, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705207
- Sponsor's protocol ID
- RC 31/20/0279
- Acronym
- DOREPAR
- Status last verified
- Aug 2023
- First submitted
- 5 Jan 2021
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boussac M, Harroch E, Joineau K, Descamps E, Brefel-Courbon C. Neuro-functional correlates of personality dimensions in Parkinson's disease. Front Pharmacol. 2025 Nov 7;16:1705937. doi: 10.3389/fphar.2025.1705937. eCollection 2025.
PubMed 41282613Joineau K, Harroch E, Boussac M, Fabbri M, Leung C, Ory-Magne F, Rousseau V, Peran P, Brefel-Courbon C, Descamps E. Effect of foot reflexology on chronic pain in Parkinson's disease: A randomized controlled trial. PLoS One. 2025 Jul 28;20(7):e0327865. doi: 10.1371/journal.pone.0327865. eCollection 2025.
PubMed 40720491
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Impact of Foot Reflexology on Chronic Pain in Parkinsonian Patients
- ClinicalTrials.gov ID
- NCT04705207
- Acronym / sponsor ID
- DOREPAR / RC 31/20/0279
- Conditions
- Parkinson Disease
- Keywords
- Pain, Foot Reflexology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 12 Jan 2021 (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.
Pain is one of the non-motor symptoms of Parkinson's disease still poorly known and misdiagnosed and its management is complex. This encourage to explore new non-drug therapeutic paths, such as foot reflexology (FR). the present study proposed a comparison of the evolution of different parameters, quantitative and qualitative, to identify biomarkers and highlight the specific effect of FR on pain, compared to sham massage.
Detailed description
Parkinson's disease (PD) is a neurodegenerative disease characterized by the destruction of specific neurons population involved in movement control. Pain is one of the non-motor symptoms still poorly known and misdiagnosed. In addition to this fact, its management is complex. At present, the medical community has no effective solution to reduce pain to an acceptable level in terms of intensity or frequency.
Pain is a personal, subjective experience with an affective and cognitive dimension. The context and its psychological impact can amplify as well as alleviate the pain. Thus, non-pharmacological treatment (NPT) that influence the psychological state (mood, level of stress, ...) can also modulate the pain experience through the brain matrix of pain. Among them, foot reflexology, which by stimulating reflex zones located on the feet, makes it possible to modify the perception of the pain and to modify the subjective / emotional valence of the pain. In this study, we propose to evaluate this technique, by postulating that it should reduce the chronic pain of patients with Parkinson's disease.
This project is innovative and original in two dimensions : On the one hand, the pain of patients in PD is still often underestimated, there is in the mere fact of devoting a study a real dynamic of change in the consideration of the patients concerned and in the management of this non-motor symptom. On the other hand, the increasing use of NPT requires that clinical studies be conducted. To date, it is clear that very few or no reliable studies have been conducted on the subject. We wish to develop complementary non-pharmacological management to provide concrete help to Parkinson's patients and thus initiate the scientific validation of NPT as recommended by the High Authority of Health.
The study hypothesize 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 FR on pain, compared to sham massage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- a group has intervention, a group has placebo intervention
| Arm | Type | Receives |
|---|---|---|
| reflexology massage | Experimental | Procedure: reflexology massagefoot reflexology massage |
| sham massage | Placebo comparator | Procedure: sham massagetraditional foot massage |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with an age egal at 18 years old or more,
- Patient presenting a little fluctuating Parkinson's disease attested by a score ≤ 2 on the MDS UPDRS IV,
- Patients with chronic pain for at least 3 months with a VAS ≥ 4
- Patients whose anti-parkinsonian treatment is stable throughout the duration of the study and at least for 4 weeks.
Key exclusion criteria (8 listed)
- Patients with cognitive impairment defined by an MOCA<25
- Patient presenting contraindication to carrying out the MRI examination
- Patient refusing to be informed of any abnormality detected on brain MRI
- Patient included in a clinical trial that potentially interferes with the objective of the study,
- Patient resistant to foot massage,
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 massagethe patient receive only foot reflexology massage | Procedure or surgery | reflexology massage |
| sham massagethe patient receive only foot traditional massage | Procedure or surgery | sham massage |
Primary outcome
evaluation of changes in the mean intensity of chronic pain
Time frame: Day 1 and week 12
Visual Analog Scale (VAS) ok pain (0 is no pain, 10 is the most high pain)
8 secondary outcomes
evaluation of the change in pain on the VAS
Time frame: Day 1, week 3, week 6, week 9 and week 12
evaluation of change in chronic pain
Time frame: Day 1 and week 12
evaluation of change in chronic pain
Time frame: Day 1 and week 12
evaluation of change in chronic pain
Time frame: Day 1 and week 12
evaluation of the consumption of analgesics
Time frame: Day 1, week 3, week 6, week 9 and week 12
evaluation of anxiety and depression
Time frame: Day 1 and week 12
connectivity of brain networks
Time frame: Day 1 and week 12
evaluation of the threshold of perception of subjective warm pain
Time frame: Day 1, week 9 and week 12
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 24 Aug 2023.
- Derived from this study: PubMed 41282613Boussac M, Harroch E, Joineau K, Descamps E, Brefel-Courbon C. Neuro-functional correlates of personality dimensions in Parkinson's disease. Front Pharmacol. 2025 Nov 7;16:1705937. doi: 10.3389/fphar.2025.1705937. eCollection 2025.
- Derived from this study: PubMed 40720491Joineau K, Harroch E, Boussac M, Fabbri M, Leung C, Ory-Magne F, Rousseau V, Peran P, Brefel-Courbon C, Descamps E. Effect of foot reflexology on chronic pain in Parkinson's disease: A randomized controlled trial. PLoS One. 2025 Jul 28;20(7):e0327865. doi: 10.1371/journal.pone.0327865. eCollection 2025.
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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.
Christine BREFEL-COURBON, MD principal investigator
University Hospital, Toulouse
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 Parkinson Disease, 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 4 inclusion and 8 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 24 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
evaluation of changes in the mean intensity of chronic pain (time frame: Day 1 and week 12). 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 NCT04705207, which also lists 2 linked publications.
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 24 Aug 2023.