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

NCT06012097 | Recruiting Phase 4

• 1 other identifier: 7452
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

De Quervain Disease

Outcome Measures

Primary Outcomes (3)

• Measure of pain during the WHAT test

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

  Day 0

• Measure of pain during the WHAT test

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

  Day 42

• Measure of pain during the WHAT test

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

  Day 84

Study Arms (2)

active comparator

ACTIVE COMPARATOR

Diclofenac gel Splint of the thumb and wrist

Drug: Diclofenac gel

Experimental Group

EXPERIMENTAL

Aromatherapy Gel Splint of the thumb and wrist

Drug: Aromatherapy gel

Interventions

Diclofenac gel DRUG

using diclofenac as a comparator

active comparator

Aromatherapy gel DRUG

using Aromatherapy gel as an experimetnal treatment

Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service SOS Main

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

De Quervain Disease

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Central Study Contacts

Marie SCHWEBEL

CONTACT

03 68 76 53 40; marie.schwebel@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: June 4, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)