Foot Reflexology on Chronic Pain in Parkinsonian Patients (DOREPAR)

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: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Procedure: reflexology massage; Procedure: 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • University Hospital of Toulouse

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)	Day 1 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Day 1 and week 12
evaluation of change in chronic pain	Brief Pain Inventory (BPI)	Day 1 and week 12
evaluation of change in chronic pain	Primary Parkinsonian Pain Diagnostic Questionnaire (3PDQ)	Day 1 and week 12
evaluation of the consumption of analgesics	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	Hospital Anxiety Depression (HAD) scale	Day 1 and week 12
connectivity of brain networks	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	contact thermode is used to dermine the threshold of perception	Day 1, week 9 and week 12

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Christine Brefel-Courbon, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): May 25, 2023
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Foot Reflexology
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Chronic Pain
• Other Study ID 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