Foot Reflexology on Chronic Pain in Parkinsonian Patients (DOREPAR)

August 22, 2023 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Toulouse, France
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: reflexology massage
foot reflexology massage
Procedure: reflexology massage
the patient receive only foot reflexology massage
Placebo Comparator: sham massage
traditional foot massage
Procedure: sham massage
the patient receive only foot traditional massage

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Day 1 and week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
evaluation of the change in pain on the VAS
Time Frame: Day 1, week 3, week 6, week 9 and week 12
Visual Analog Scale of change of pain (0 is no pain, 10 is the most high pain)
Day 1, week 3, week 6, week 9 and week 12
evaluation of change in chronic pain
Time Frame: Day 1 and week 12
King's Parkinson's disease Pain Scale (KPPS)
Day 1 and week 12
evaluation of change in chronic pain
Time Frame: Day 1 and week 12
Brief Pain Inventory (BPI)
Day 1 and week 12
evaluation of change in chronic pain
Time Frame: Day 1 and week 12
Primary Parkinsonian Pain Diagnostic Questionnaire (3PDQ)
Day 1 and week 12
evaluation of the consumption of analgesics
Time Frame: Day 1, week 3, week 6, week 9 and week 12
completion by the patient of a logbook of analgesic treatments
Day 1, week 3, week 6, week 9 and week 12
evaluation of anxiety and depression
Time Frame: Day 1 and week 12
Hospital Anxiety Depression (HAD) scale
Day 1 and week 12
connectivity of brain networks
Time Frame: Day 1 and week 12
observation of connectivity cards by Functional Magnetic Resonance Imaging (MRI)
Day 1 and week 12
evaluation of the threshold of perception of subjective warm pain
Time Frame: Day 1, week 9 and week 12
contact thermode is used to dermine the threshold of perception
Day 1, week 9 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christine Brefel-Courbon, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC 31/20/0279

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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