Back to resultsHypnosis and MEOPA in Regional Painful Syndrome Complex (ProHKM-SDRC)
Primary Purpose
Algodystrophy of Hand
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypnosis, kinesitherapy, MEOPA
Usual practice
Sponsored by
About this trial
This is an interventional supportive care trial for Algodystrophy of Hand
Eligibility Criteria
Inclusion Criteria:
- Regional Painful Syndrome Complex
Exclusion Criteria:
- deaf people
Sites / Locations
- Croix du Sud
- University Hospital of Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Hypnosis Kinesitherapy and MEOPA
usual practice
Arm Description
combined therapy of Hypnosis Kinesitherapy and MEOPA (HKM)
physiopathology and treatments
Outcomes
Primary Outcome Measures
Pain intensity measure using visual analogical ladder (EVA)
pain intensity is determined by patient himself on a visual analogical ladder created by Huskisson
Secondary Outcome Measures
QDSA ( Saint Antoine Pain Questions)
description of the type of pain
SF36 (Short Form (36) Health Survey)
quality of life appreciation
HADs
Hospital Anxiety and Depression Scale
Full Information
NCT ID
NCT03260361
First Posted
January 24, 2017
Last Updated
August 22, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03260361
Brief Title
Hypnosis and MEOPA in Regional Painful Syndrome Complex
Acronym
ProHKM-SDRC
Official Title
Combined Therapy of Hypnosis Kinesitherapy and MEOPA in Patients With Regional Painful Syndrome Complex
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
November 7, 2022 (Actual)
Study Completion Date
December 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Relation between hypnosis and MEOPA on algodystrophy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Algodystrophy of Hand
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypnosis Kinesitherapy and MEOPA
Arm Type
Experimental
Arm Description
combined therapy of Hypnosis Kinesitherapy and MEOPA (HKM)
Arm Title
usual practice
Arm Type
Other
Arm Description
physiopathology and treatments
Intervention Type
Other
Intervention Name(s)
Hypnosis, kinesitherapy, MEOPA
Other Intervention Name(s)
Hypnosis Kinesitherapy and MEOPA (HKM)
Intervention Description
classical intervention
Intervention Type
Other
Intervention Name(s)
Usual practice
Intervention Description
Usual practice with treatments and physio
Primary Outcome Measure Information:
Title
Pain intensity measure using visual analogical ladder (EVA)
Description
pain intensity is determined by patient himself on a visual analogical ladder created by Huskisson
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
QDSA ( Saint Antoine Pain Questions)
Description
description of the type of pain
Time Frame
3 weeks
Title
SF36 (Short Form (36) Health Survey)
Description
quality of life appreciation
Time Frame
3 weeks
Title
HADs
Description
Hospital Anxiety and Depression Scale
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Regional Painful Syndrome Complex
Exclusion Criteria:
deaf people
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine QUINTARD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Croix du Sud
City
Quint Fonsegrives
ZIP/Postal Code
31130
Country
France
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10524476
Citation
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.
Results Reference
background
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Hypnosis and MEOPA in Regional Painful Syndrome Complex
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