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

Primary Purpose

Rhizarthrosis

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Leeches
Diclofenac
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhizarthrosis

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin am Immanuel-Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Leeches

Diclofenac

Arm Description

One-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base

3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks

Outcomes

Primary Outcome Measures

Disabilities of the Arm, Shoulder and Hand (DASH)

Secondary Outcome Measures

Visual analog scale (VAS)
Medication on demand
Documentation in daily diary

Full Information

First Posted
January 11, 2017
Last Updated
February 11, 2019
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03020368
Brief Title
Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint
Official Title
Effectiveness and Safety of Breeded Leech "Medileech" by BioRepro GmbH for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhizarthrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Leeches
Arm Type
Experimental
Arm Description
One-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base
Arm Title
Diclofenac
Arm Type
Active Comparator
Arm Description
3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks
Intervention Type
Biological
Intervention Name(s)
Leeches
Other Intervention Name(s)
Hirudo verbana
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Primary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame
Change after 28 and 56 days
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS)
Time Frame
Change after 7, 28 and 56 days
Title
Medication on demand
Description
Documentation in daily diary
Time Frame
Documentation between baseline and day 56
Other Pre-specified Outcome Measures:
Title
Expectation
Description
5-stage Likert scale for the expectation of symptomatic efficacy after group assignment
Time Frame
Baseline
Title
Overall assessment of efficacy and tolerability
Description
5-stage Likert scale documented by the patient as well as by the doctor at the end of the study
Time Frame
Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, Prof. Dr.
Organizational Affiliation
Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin am Immanuel-Krankenhaus
City
Berlin
ZIP/Postal Code
14109
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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