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Completed

NCT Number: NCT04705207

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse

Toulouse, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

reflexology massage

Procedure

the patient receive only foot reflexology massage

Sham massage

Procedure

the patient receive only foot traditional massage

Primary outcomes

  1. evaluation of changes in the mean intensity of chronic pain

    Time frame: Day 1 and week 12

    Visual Analog Scale (VAS) ok pain (0 is no pain, 10 is the most high pain)

Secondary outcomes

  1. evaluation of the change in pain on the VAS

    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)

  2. evaluation of change in chronic pain

    Time frame: Day 1 and week 12

    King's Parkinson's disease Pain Scale (KPPS)

  3. evaluation of change in chronic pain

    Time frame: Day 1 and week 12

    Brief Pain Inventory (BPI)

  4. evaluation of change in chronic pain

    Time frame: Day 1 and week 12

    Primary Parkinsonian Pain Diagnostic Questionnaire (3PDQ)

  5. evaluation of the consumption of analgesics

    Time frame: Day 1, week 3, week 6, week 9 and week 12

    completion by the patient of a logbook of analgesic treatments

  6. evaluation of anxiety and depression

    Time frame: Day 1 and week 12

    Hospital Anxiety Depression (HAD) scale

  7. connectivity of brain networks

    Time frame: Day 1 and week 12

    observation of connectivity cards by Functional Magnetic Resonance Imaging (MRI)

  8. evaluation of the threshold of perception of subjective warm pain

    Time frame: Day 1, week 9 and week 12

    contact thermode is used to dermine the threshold of perception

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Exploratory Study of the Impact of Foot Reflexology on Chronic Pain in Parkinsonian Patients

Acronym: DOREPAR

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2021
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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