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

Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease : Monocentric Study, Controlled, Randomized, Partially Blinded, in Paralleled Groups

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.

Study Overview

• Status: Not yet recruiting
• Conditions: De Quervain Disease
• Intervention / Treatment: Drug: Diclofenac gel; Drug: Aromatherapy gel

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Marie SCHWEBEL; Phone Number: 03 68 76 53 40; Email: marie.schwebel@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active comparator; Diclofenac gel Splint of the thumb and wrist	Drug: Diclofenac gel; using diclofenac as a comparator
Experimental: Experimental Group; Aromatherapy Gel Splint of the thumb and wrist	Drug: Aromatherapy gel; using Aromatherapy gel as an experimetnal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; De Quervain Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: 7452

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