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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Strasbourg, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diclofenac gel

    Drug

    using diclofenac as a comparator

  • Aromatherapy gel

    Drug

    using Aromatherapy gel as an experimetnal treatment

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: active comparatorActive comparator 1 intervention
Group B: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Measure of pain during the WHAT test

Visual analogue pain scale (quotation between 0 and 10) during WHAT Test

Time frame
Day 0
2

Measure of pain during the WHAT test

Visual analogue pain scale (quotation between 0 and 10) during WHAT Test

Time frame
Day 42
3

Measure of pain during the WHAT test

Visual analogue pain scale (quotation between 0 and 10) during WHAT Test

Time frame
Day 84

Secondary outcomes

Other outcomes

Sponsors and contacts

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