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Hypnosis and MEOPA (ProHKM-SDRC)

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ClinicalTrials.gov Identifier: NCT03260361
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Relation between hypnosis and MEOPA on algodystrophy.

Condition or disease Intervention/treatment Phase
Algodystrophy of Hand Other: Hypnosis, kinesitherapy, MEOPA Other: Usual practice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Hypnosis and MEOPA
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypnosis Kinesitherapy and MEOPA
combined therapy of Hypnosis Kinesitherapy and MEOPA (HKM)
Other: Hypnosis, kinesitherapy, MEOPA
classical intervention
Other Name: Hypnosis Kinesitherapy and MEOPA (HKM)

usual practice
physiopathology and treatments
Other: Usual practice
Usual practice with treatments and physio




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. QDSA ( Saint Antoine Pain Questions) [ Time Frame: 3 weeks ]
    description of the type of pain

  2. SF36 (Short Form (36) Health Survey) [ Time Frame: 3 weeks ]
    quality of life appreciation

  3. HADs [ Time Frame: 3 weeks ]
    Hospital Anxiety and Depression Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Regional Painful Syndrome Complex

Exclusion Criteria:

  • deaf people

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260361


Contacts
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Contact: Michel OLIVIER, MD 33 5 61 77 22 33 olivier.m@chu-toulouse.fr
Contact: Martine QUINTARD, NURSE 33 5 61 7 86 03 quintard.m@chu-toulouse.fr

Locations
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France
Bigorre Tarbes Hospital Not yet recruiting
Tarbes, France, 65013
Contact: Ishwarlall TAPESAR    33 5 62 94 47 70      
University Hospital of Toulouse Recruiting
Toulouse, France, 31059
Contact: Michel Olivier, MD    33 5 61 77 22 33      
Contact: Martine Quintard, Nurse    33 5 61 77 22 33      
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Martine QUINTARD University Hospital, Toulouse

Publications:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03260361     History of Changes
Other Study ID Numbers: RC31/16/8235
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Reflex Sympathetic Dystrophy
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases