- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03260361
Hypnosis and MEOPA in Regional Painful Syndrome Complex (ProHKM-SDRC)
August 22, 2023 updated by: University Hospital, Toulouse
Combined Therapy of Hypnosis Kinesitherapy and MEOPA in Patients With Regional Painful Syndrome Complex
Relation between hypnosis and MEOPA on algodystrophy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Quint Fonsegrives, France, 31130
- Croix du Sud
-
Toulouse, France, 31059
- University Hospital of Toulouse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Regional Painful Syndrome Complex
Exclusion Criteria:
- deaf people
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypnosis Kinesitherapy and MEOPA
combined therapy of Hypnosis Kinesitherapy and MEOPA (HKM)
|
classical intervention
Other Names:
|
|
Other: usual practice
physiopathology and treatments
|
Usual practice with treatments and physio
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity measure using visual analogical ladder (EVA)
Time Frame: 3 weeks
|
pain intensity is determined by patient himself on a visual analogical ladder created by Huskisson
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
QDSA ( Saint Antoine Pain Questions)
Time Frame: 3 weeks
|
description of the type of pain
|
3 weeks
|
|
SF36 (Short Form (36) Health Survey)
Time Frame: 3 weeks
|
quality of life appreciation
|
3 weeks
|
|
HADs
Time Frame: 3 weeks
|
Hospital Anxiety and Depression Scale
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martine QUINTARD, University Hospital, Toulouse
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2017
Primary Completion (Actual)
November 7, 2022
Study Completion (Actual)
December 7, 2022
Study Registration Dates
First Submitted
January 24, 2017
First Submitted That Met QC Criteria
August 21, 2017
First Posted (Actual)
August 24, 2017
Study Record Updates
Last Update Posted (Actual)
August 23, 2023
Last Update Submitted That Met QC Criteria
August 22, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/16/8235
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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