Parkinson Disease
Conditions
Keywords
Pain, Foot Reflexology
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.
Interventions
PROCEDUREreflexology massage
the patient receive only foot reflexology massage
PROCEDUREsham massage
the patient receive only foot traditional massage
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
placebo is a traditional massage instead of a intervention reflexology massage
Intervention model description
a group has intervention, a group has placebo intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of changes in the mean intensity of chronic pain | Day 1 and week 12 | Visual Analog Scale (VAS) ok pain (0 is no pain, 10 is the most high pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of change in chronic pain | Day 1 and week 12 | King's Parkinson's disease Pain Scale (KPPS) |
| evaluation of the consumption of analgesics | Day 1, week 3, week 6, week 9 and week 12 | completion by the patient of a logbook of analgesic treatments |
| evaluation of the change in pain on the VAS | 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) |
| connectivity of brain networks | Day 1 and week 12 | observation of connectivity cards by Functional Magnetic Resonance Imaging (MRI) |
| evaluation of the threshold of perception of subjective warm pain | Day 1, week 9 and week 12 | contact thermode is used to dermine the threshold of perception |
| evaluation of anxiety and depression | Day 1 and week 12 | Hospital Anxiety Depression (HAD) scale |
Countries
France
Outcome results
None listed