Using gel aromatherapy to relieve pain in patients with De Quervain disease
Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease : Monocentric Study, Controlled, Randomized, Partially Blinded, in Paralleled Groups
This study is testing if a new aromatherapy gel can help relieve pain in people with De Quervain disease better than the usual diclofenac gel.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06012097 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of aromatherapy gel compared to traditional diclofenac gel for treating pain in patients with De Quervain disease, a condition characterized by inflammation of specific tendons in the wrist. The trial aims to provide an alternative treatment option that may have fewer undesirable effects than current therapies. Participants will be recruited from the Hand Surgery and Rheumatology Departments at Strasbourg University Hospitals, and will receive either the aromatherapy gel or the diclofenac gel. The study will assess pain relief and functional improvement in the affected wrist.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 75 with unilateral De Quervain's tenosynovitis.
Not a fit: Patients who are pregnant, breastfeeding, or allergic to components of the gels will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safer and more effective pain management option for patients suffering from De Quervain disease.
How similar studies have performed: While the use of aromatherapy in pain management is gaining interest, this specific approach has not been widely tested in similar studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Strasbourg
- Service SOS Main — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Marie SCHWEBEL
- Email: marie.schwebel@chru-strasbourg.fr
- Phone: 03 68 76 53 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.