Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this trial the investigators want to prove the efficacy and safety of a one-time topical leech application at patients with symptomatic primary arthrosis of the first carpometacarpal joint in comparison to the standard therapy with topical diclofenac.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leeches | Experimental | One-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base |
|
| Diclofenac | Active Comparator | 3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leeches | Biological |
|
| |
| Diclofenac |
| Measure | Description | Time Frame |
|---|---|---|
| Disabilities of the Arm, Shoulder and Hand (DASH) | Change after 28 and 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale (VAS) | Change after 7, 28 and 56 days | |
| Medication on demand | Documentation in daily diary | Documentation between baseline and day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Expectation | 5-stage Likert scale for the expectation of symptomatic efficacy after group assignment | Baseline |
| Overall assessment of efficacy and tolerability | 5-stage Likert scale documented by the patient as well as by the doctor at the end of the study |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andreas Michalsen, Prof. Dr. | Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin am Immanuel-Krankenhaus | Berlin | 14109 | Germany |
Not provided
| ID | Term |
|---|---|
| D024763 | Leeching |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Day 56 |
| D009930 |
| Organic Chemicals |