NCT03260361

Brief Summary

Relation between hypnosis and MEOPA on algodystrophy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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 24, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

September 6, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2022

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

5.2 years

First QC Date

January 24, 2017

Last Update Submit

August 22, 2023

Conditions

Algodystrophy of Hand

Outcome Measures

Primary Outcomes (1)

  • Pain intensity measure using visual analogical ladder (EVA)

    pain intensity is determined by patient himself on a visual analogical ladder created by Huskisson

    3 weeks

Secondary Outcomes (3)

  • QDSA ( Saint Antoine Pain Questions)

    3 weeks

  • SF36 (Short Form (36) Health Survey)

    3 weeks

  • HADs

    3 weeks

Study Arms (2)

Hypnosis Kinesitherapy and MEOPA

EXPERIMENTAL

combined therapy of Hypnosis Kinesitherapy and MEOPA (HKM)

Other: Hypnosis, kinesitherapy, MEOPA

usual practice

OTHER

physiopathology and treatments

Other: Usual practice

Interventions

Hypnosis, kinesitherapy, MEOPAOTHER

classical intervention

Also known as: Hypnosis Kinesitherapy and MEOPA (HKM)
Hypnosis Kinesitherapy and MEOPA
Usual practiceOTHER

Usual practice with treatments and physio

usual practice

Eligibility Criteria

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

You may qualify if:

  • Regional Painful Syndrome Complex

You may not qualify if:

  • deaf people

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Croix du Sud

Quint-Fonsegrives, 31130, France

Location

University Hospital of Toulouse

Toulouse, 31059, France

Location

Related Publications (1)

  • Oerlemans HM, Oostendorp RA, de Boo T, Perez RS, Goris RJ. Signs and symptoms in complex regional pain syndrome type I/reflex sympathetic dystrophy: judgment of the physician versus objective measurement. Clin J Pain. 1999 Sep;15(3):224-32. doi: 10.1097/00002508-199909000-00010.

    PMID: 10524476BACKGROUND

MeSH Terms

Interventions

HypnosisMeopa

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Martine QUINTARD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2017

First Posted

August 24, 2017

Study Start

September 6, 2017

Primary Completion

November 7, 2022

Study Completion

December 7, 2022

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)