University Hospital of Toulouse
Toulouse, France
NCT Number: NCT04705207
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.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Toulouse, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the patient receive only foot reflexology massage
the patient receive only foot traditional massage
Time frame: Day 1 and week 12
Visual Analog Scale (VAS) ok pain (0 is no pain, 10 is the most high pain)
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)
Time frame: Day 1 and week 12
King's Parkinson's disease Pain Scale (KPPS)
Time frame: Day 1 and week 12
Brief Pain Inventory (BPI)
Time frame: Day 1 and week 12
Primary Parkinsonian Pain Diagnostic Questionnaire (3PDQ)
Time frame: Day 1, week 3, week 6, week 9 and week 12
completion by the patient of a logbook of analgesic treatments
Time frame: Day 1 and week 12
Hospital Anxiety Depression (HAD) scale
Time frame: Day 1 and week 12
observation of connectivity cards by Functional Magnetic Resonance Imaging (MRI)
Time frame: Day 1, week 9 and week 12
contact thermode is used to dermine the threshold of perception
University Hospital, Toulouse
Other
Exploratory Study of the Impact of Foot Reflexology on Chronic Pain in Parkinsonian Patients
Acronym: DOREPAR
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