Clinical trial NCT04705207: Foot Reflexology on Chronic Pain in Parkinsonian Patients
Official title: Exploratory Study of the Impact of Foot Reflexology on Chronic Pain in Parkinsonian Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Pain
Foot Reflexology
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a group has intervention, a group has placebo intervention
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: evaluation of changes in the mean intensity of chronic pain
timeFrame: Day 1 and week 12
Secondary outcomes:
measure: evaluation of the change in pain on the VAS
timeFrame: Day 1, week 3, week 6, week 9 and week 12
measure: evaluation of change in chronic pain
timeFrame: Day 1 and week 12
measure: evaluation of change in chronic pain
timeFrame: Day 1 and week 12
measure: evaluation of change in chronic pain
timeFrame: Day 1 and week 12
measure: evaluation of the consumption of analgesics
timeFrame: Day 1, week 3, week 6, week 9 and week 12
measure: evaluation of anxiety and depression
timeFrame: Day 1 and week 12
measure: connectivity of brain networks
timeFrame: Day 1 and week 12
measure: evaluation of the threshold of perception of subjective warm pain
timeFrame: Day 1, week 9 and week 12
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Christine BREFEL-COURBON, MD
role: PRINCIPAL_INVESTIGATOR
References: