Evaluating wrist orthoses for managing carpal tunnel syndrome
Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome
This study is testing two different types of wrist braces to see which one helps people with carpal tunnel syndrome feel better and recover more effectively without surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Saint Joseph Saint Luc de Lyon Academic / other |
| Locations | 5 sites (Bron and 4 other locations) |
| Trial ID | NCT05483218 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two types of nocturnal wrist orthoses in the non-surgical management of carpal tunnel syndrome. Patients diagnosed with the condition will be randomized into two groups, one receiving a simple rest orthosis and the other a global rest orthosis. The study aims to assess symptom reduction, comfort, compliance, and the impact on neurological and muscular recovery over a three-month period. Follow-up will include telephone interviews and consultations to monitor progress and functional outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with unilateral or bilateral carpal tunnel syndrome who do not require surgical intervention.
Not a fit: Patients with severe carpal tunnel syndrome or those currently participating in other research protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option that effectively alleviates symptoms of carpal tunnel syndrome.
How similar studies have performed: Other studies have shown promise in using orthotic devices for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age with unilateral or bilateral, idiopathic or secondary carpal tunnel syndrome, without surgical indication (EMG with myelin sensory signs without axonal involvement) * signed consent * Affiliation to social security Exclusion Criteria: * Patients with carpal tunnel syndrome with severity criteria * Patient refusal * Patient with disorders (psychological, behavioral) that may lead to poor compliance with the study treatment * Presence of skin lesion in the area of the orthosis * Current participation in another research protocol involving the human person
Where this trial is running
Bron and 4 other locations
- Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon — Bron, France (Recruiting)
- Centre Hospitalier Saint Joseph Saint Luc — Lyon, France (Recruiting)
- Centre Orthopédique Santy — Lyon, France (Recruiting)
- SELARL de Neurologie Bullukian — Lyon, France (Recruiting)
- Médipôle Hôpital Mutualiste — Villeurbanne, France (Recruiting)
Study contacts
- Study coordinator: Philippe SCHIELE, MD
- Email: pschiele@chsjsl.fr
- Phone: 0 478 618 624
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.