NCT04705207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 14, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

2.1 years

First QC Date

January 5, 2021

Last Update Submit

August 22, 2023

Conditions

Parkinson Disease

Keywords

PainFoot Reflexology

Outcome Measures

Primary Outcomes (1)

  • 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)

    Day 1 and week 12

Secondary Outcomes (8)

  • evaluation of the change in pain on the VAS

    Day 1, week 3, week 6, week 9 and week 12

  • evaluation of change in chronic pain

    Day 1 and week 12

  • evaluation of change in chronic pain

    Day 1 and week 12

  • evaluation of change in chronic pain

    Day 1 and week 12

  • evaluation of the consumption of analgesics

    Day 1, week 3, week 6, week 9 and week 12

  • +3 more secondary outcomes

Study Arms (2)

reflexology massage

EXPERIMENTAL

foot reflexology massage

Procedure: reflexology massage

sham massage

PLACEBO COMPARATOR

traditional foot massage

Procedure: sham massage

Interventions

reflexology massagePROCEDURE

the patient receive only foot reflexology massage

reflexology massage
sham massagePROCEDURE

the patient receive only foot traditional massage

sham massage

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

Location

Related Publications (2)

  • Boussac M, Harroch E, Joineau K, Descamps E, Brefel-Courbon C. Neuro-functional correlates of personality dimensions in Parkinson's disease. Front Pharmacol. 2025 Nov 7;16:1705937. doi: 10.3389/fphar.2025.1705937. eCollection 2025.

    PMID: 41282613DERIVED

  • Joineau K, Harroch E, Boussac M, Fabbri M, Leung C, Ory-Magne F, Rousseau V, Peran P, Brefel-Courbon C, Descamps E. Effect of foot reflexology on chronic pain in Parkinson's disease: A randomized controlled trial. PLoS One. 2025 Jul 28;20(7):e0327865. doi: 10.1371/journal.pone.0327865. eCollection 2025.

    PMID: 40720491DERIVED

MeSH Terms

Conditions

Parkinson DiseasePain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Christine BREFEL-COURBON, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
placebo is a traditional massage instead of a intervention reflexology massage
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: a group has intervention, a group has placebo intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 12, 2021

Study Start

April 14, 2021

Primary Completion

May 25, 2023

Study Completion

May 25, 2023

Last Updated

August 24, 2023

Record last verified: 2023-08

Locations

FR(1)