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Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease (Helping Hand)

Primary Purpose

De Quervain Disease

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Diclofenac gel
Aromatherapy gel
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for De Quervain Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patient aged 18 to 75, Patient with unilateral De Quervain's tenosynovitis, Patient cared in the Hand Surgery Department, SOS Mains Emergency Department or Rheumatology Department of Strasbourg University Hospitals, Patient informed of the results of the prior medical examination, Informed consent signed by the patient, Patient affiliated to a health insurance social protection scheme or beneficiary, For a woman of childbearing potential, negative urine pregnancy test at the inclusion visit and maintenance of effective contraception throughout the study. Exclusion Criteria: Pregnant or breastfeeding patient, Patient allergic to a component of the gel with essential oils, Dicloflenac®, NSAIDs, or one of the excipients Patient treated with oral non-steroidal anti-inflammatory drugs Patient with ongoing treatment with another ointment at the treatment application site (radial edge of the wrist) Patient with damaged skin, whatever the lesion: oozing dermatosis, eczema, infected lesion, burn or wound, Patient with atopic skin disease, Patient with epilepsy or with a history of epilepsy, Patient with a history of homolateral De Quervain's tenosynovitis, or having already had corticosteroid infiltrations in the 6 months before his inclusion on the ipsilateral side of the pathology, Patient with associated tendinopathies in the elbow or forearm region, Impossibility of giving the patient information (patient in an emergency situation, patient with difficulties of understandin, agitation of the patient), Patient under legal protection, under guardianship or curatorship.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    active comparator

    Experimental Group

    Arm Description

    Diclofenac gel Splint of the thumb and wrist

    Aromatherapy Gel Splint of the thumb and wrist

    Outcomes

    Primary Outcome Measures

    Measure of pain during the WHAT test
    Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
    Measure of pain during the WHAT test
    Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
    Measure of pain during the WHAT test
    Visual analogue pain scale (quotation between 0 and 10) during WHAT Test

    Secondary Outcome Measures

    Full Information

    First Posted
    August 21, 2023
    Last Updated
    August 21, 2023
    Sponsor
    University Hospital, Strasbourg, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06012097
    Brief Title
    Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease
    Acronym
    Helping Hand
    Official Title
    Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease : Monocentric Study, Controlled, Randomized, Partially Blinded, in Paralleled Groups
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    April 1, 2026 (Anticipated)
    Study Completion Date
    April 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Strasbourg, France

    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
    De Quervain disease is characterized by an adductor pollicis longus and extensor pollicis brevis tendons inflammation as thys pass beneath the extensor retinaculum at the radial styloid. This pathology is recognized as a musculoskeletal disorder of the upper limb triggering functional deficits resulting to possible modifications in the professional activity, sources of absenteeism, thus constituting an economic cost for society. At the etiological level, this pathology also affects young mothers (it's called "mother's wrist" or mommy thumb"), mobile phone users ("textonite", "Blackberryte") or video game players ("Nintendoite"). Currently, the treatment is mainly conservative by splint and anti-inflammatory gel and/or corticosteroid infiltration. Howewer, these therapies have undesirable effects. The interest of this study is therefore to propose another therapy based on aromatherapy gel.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    De Quervain Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    active comparator
    Arm Type
    Active Comparator
    Arm Description
    Diclofenac gel Splint of the thumb and wrist
    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    Aromatherapy Gel Splint of the thumb and wrist
    Intervention Type
    Drug
    Intervention Name(s)
    Diclofenac gel
    Intervention Description
    using diclofenac as a comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Aromatherapy gel
    Intervention Description
    using Aromatherapy gel as an experimetnal treatment
    Primary Outcome Measure Information:
    Title
    Measure of pain during the WHAT test
    Description
    Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
    Time Frame
    Day 0
    Title
    Measure of pain during the WHAT test
    Description
    Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
    Time Frame
    Day 42
    Title
    Measure of pain during the WHAT test
    Description
    Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
    Time Frame
    Day 84

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female patient aged 18 to 75, Patient with unilateral De Quervain's tenosynovitis, Patient cared in the Hand Surgery Department, SOS Mains Emergency Department or Rheumatology Department of Strasbourg University Hospitals, Patient informed of the results of the prior medical examination, Informed consent signed by the patient, Patient affiliated to a health insurance social protection scheme or beneficiary, For a woman of childbearing potential, negative urine pregnancy test at the inclusion visit and maintenance of effective contraception throughout the study. Exclusion Criteria: Pregnant or breastfeeding patient, Patient allergic to a component of the gel with essential oils, Dicloflenac®, NSAIDs, or one of the excipients Patient treated with oral non-steroidal anti-inflammatory drugs Patient with ongoing treatment with another ointment at the treatment application site (radial edge of the wrist) Patient with damaged skin, whatever the lesion: oozing dermatosis, eczema, infected lesion, burn or wound, Patient with atopic skin disease, Patient with epilepsy or with a history of epilepsy, Patient with a history of homolateral De Quervain's tenosynovitis, or having already had corticosteroid infiltrations in the 6 months before his inclusion on the ipsilateral side of the pathology, Patient with associated tendinopathies in the elbow or forearm region, Impossibility of giving the patient information (patient in an emergency situation, patient with difficulties of understandin, agitation of the patient), Patient under legal protection, under guardianship or curatorship.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marie SCHWEBEL
    Phone
    03 68 76 53 40
    Email
    marie.schwebel@chru-strasbourg.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease

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