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Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint

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Charité University Medicine Berlin

Status

Terminated

Conditions

Rhizarthrosis

Treatments

Biological: Leeches
Drug: Diclofenac

Study type

Interventional

Funder types

Other

Identifiers

NCT03020368
Leeches for Rhizarthrosis

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

35 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male and female patients aged 35 to 85 years
  • Pain intensity in the region of the thumb base in pain phases ≥ 40 mm on the VAS of 0 to 100 mm (relative to the last 24 hours)
  • Complaints for at least 3 months
  • X-ray Stadium Eaton I-IV at least once secured

Exclusion criteria

  • Anticoagulation (Marcumar, Heparin)
  • Haemophilia, V. Willebrandt Jürgens syndrome, thrombocytopathy and other blood anomalies
  • Combination therapy of ASA and thienopyridines
  • Pain medication with opioid analgesics
  • Systemic medication with corticoids or immunosuppressants
  • Intraarterticular injections or RSO within the last 3 months
  • Past or planned surgery on the affected joint in the next 2 months
  • Pregnancy, lactation
  • Insulin-dependent type I diabetes mellitus
  • Acute psychotic disorders
  • Severe comorbidity

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 2 patient groups

Leeches
Experimental group
Description:
One-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base
Treatment:
Biological: Leeches
Diclofenac
Active Comparator group
Description:
3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks
Treatment:
Drug: Diclofenac

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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