De Quervain DiseasePhase 4Helping HandNCT06012097
Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease
A Phase 4 study testing Diclofenac gel and Aromatherapy gel in people with De Quervain Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- De Quervain Disease
- What is being tested?
- Diclofenac gel and Aromatherapy gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2024to 1 Apr 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service SOS Main
Strasbourg, 67000
Sybille FACCA
About this study
Official title: 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.
- Conditions
- De Quervain Disease
- Being tested
- Diclofenac gel, Aromatherapy gel
- Medical subject headings
- De Quervain Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac gelDrug
using diclofenac as a comparator
Aromatherapy gelDrug
using Aromatherapy gel as an experimetnal treatment
| Study group | Role | What they receive |
|---|---|---|
| active comparator | Active comparator | Diclofenac gel Splint of the thumb and wrist Receives: Drug: Diclofenac gel |
| Experimental Group | Experimental | Aromatherapy Gel Splint of the thumb and wrist Receives: Drug: Aromatherapy gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of pain during the WHAT test
Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
Measured: Day 0
Measure of pain during the WHAT test
Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
Measured: Day 42
Measure of pain during the WHAT test
Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start4 Jun 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for De Quervain DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012097
- Sponsor's protocol ID
- 7452
- Acronym
- Helping Hand
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease : Monocentric Study, Controlled, Randomized, Partially Blinded, in Paralleled Groups
- ClinicalTrials.gov ID
- NCT06012097
- Acronym / sponsor ID
- Helping Hand / 7452
- Conditions
- De Quervain Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active comparator | Active comparator | Drug: Diclofenac gelDiclofenac gel Splint of the thumb and wrist |
| Experimental Group | Experimental | Drug: Aromatherapy gelAromatherapy Gel Splint of the thumb and wrist |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac gelusing diclofenac as a comparator | Drug | active comparator |
| Aromatherapy gelusing Aromatherapy gel as an experimetnal treatment | Drug | Experimental Group |
Primary outcome
Measure of pain during the WHAT test
Time frame: Day 0
Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
Measure of pain during the WHAT test
Time frame: Day 42
Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
Measure of pain during the WHAT test
Time frame: Day 84
Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for De Quervain Disease
Enrolling by invitation
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
Carpal Tunnel Surgery, Trigger Finger Disorder
RecruitingPhase 4
Intra-sheath vs Extra-sheath Injection for De Quervain's Tenosynovitis
De Quervain Tenosynovitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac gel and Aromatherapy gel in people with De Quervain Disease, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie SCHWEBEL (03 68 76 53 40, marie.schwebel@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of pain during the WHAT test (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.