search
Back to results

Foot Reflexology on Chronic Pain in Parkinsonian Patients (DOREPAR)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
reflexology massage
sham massage
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Pain, Foot Reflexology

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

reflexology massage

sham massage

Arm Description

foot reflexology massage

traditional foot massage

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
evaluation of change in chronic pain
King's Parkinson's disease Pain Scale (KPPS)
evaluation of change in chronic pain
Brief Pain Inventory (BPI)
evaluation of change in chronic pain
Primary Parkinsonian Pain Diagnostic Questionnaire (3PDQ)
evaluation of the consumption of analgesics
completion by the patient of a logbook of analgesic treatments
evaluation of anxiety and depression
Hospital Anxiety Depression (HAD) scale
connectivity of brain networks
observation of connectivity cards by Functional Magnetic Resonance Imaging (MRI)
evaluation of the threshold of perception of subjective warm pain
contact thermode is used to dermine the threshold of perception

Full Information

First Posted
January 5, 2021
Last Updated
August 22, 2023
Sponsor
University Hospital, Toulouse
search

1. Study Identification

Unique Protocol Identification Number
NCT04705207
Brief Title
Foot Reflexology on Chronic Pain in Parkinsonian Patients
Acronym
DOREPAR
Official Title
Exploratory Study of the Impact of Foot Reflexology on Chronic Pain in Parkinsonian Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Pain, Foot Reflexology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a group has intervention, a group has placebo intervention
Masking
ParticipantOutcomes Assessor
Masking Description
placebo is a traditional massage instead of a intervention reflexology massage
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
reflexology massage
Arm Type
Experimental
Arm Description
foot reflexology massage
Arm Title
sham massage
Arm Type
Placebo Comparator
Arm Description
traditional foot massage
Intervention Type
Procedure
Intervention Name(s)
reflexology massage
Intervention Description
the patient receive only foot reflexology massage
Intervention Type
Procedure
Intervention Name(s)
sham massage
Intervention Description
the patient receive only foot traditional massage
Primary Outcome Measure Information:
Title
evaluation of changes in the mean intensity of chronic pain
Description
Visual Analog Scale (VAS) ok pain (0 is no pain, 10 is the most high pain)
Time Frame
Day 1 and week 12
Secondary Outcome Measure Information:
Title
evaluation of the change in pain on the VAS
Description
Visual Analog Scale of change of pain (0 is no pain, 10 is the most high pain)
Time Frame
Day 1, week 3, week 6, week 9 and week 12
Title
evaluation of change in chronic pain
Description
King's Parkinson's disease Pain Scale (KPPS)
Time Frame
Day 1 and week 12
Title
evaluation of change in chronic pain
Description
Brief Pain Inventory (BPI)
Time Frame
Day 1 and week 12
Title
evaluation of change in chronic pain
Description
Primary Parkinsonian Pain Diagnostic Questionnaire (3PDQ)
Time Frame
Day 1 and week 12
Title
evaluation of the consumption of analgesics
Description
completion by the patient of a logbook of analgesic treatments
Time Frame
Day 1, week 3, week 6, week 9 and week 12
Title
evaluation of anxiety and depression
Description
Hospital Anxiety Depression (HAD) scale
Time Frame
Day 1 and week 12
Title
connectivity of brain networks
Description
observation of connectivity cards by Functional Magnetic Resonance Imaging (MRI)
Time Frame
Day 1 and week 12
Title
evaluation of the threshold of perception of subjective warm pain
Description
contact thermode is used to dermine the threshold of perception
Time Frame
Day 1, week 9 and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine BREFEL-COURBON, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

Learn more about this trial

Foot Reflexology on Chronic Pain in Parkinsonian Patients

We'll reach out to this number within 24 hrs