NCT01744522

Brief Summary

The purpose of this study is to investigate, whether leech therapy for the treatment of postherpetic pain improves pain and sensory function. Therefore 20 patients with PHN undergoing leech therapy at the investigators outpatient clinic will be included in this observational trial.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

1.6 years

First QC Date

December 5, 2012

Last Update Submit

April 10, 2014

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Pain intensity measured on a visual analogue scale (0-100mm, 100mm indicating worst pain imaginable)

    28 days

Secondary Outcomes (10)

  • Pain intensity

    3 months

  • Pain quality

    28 Days

  • Pain quality

    3 months

  • Impairment

    28 days

  • Impairment

    3 months

  • +5 more secondary outcomes

Study Arms (1)

Leech therapy

Patients receiving leech therapy in the outpatient clinic

Procedure: Leech therapy

Interventions

Leech therapyPROCEDURE

Leech therapy: Using medicinal leeches After piercing the skin and injecting anticoagulants (hirudin) and anaesthetics, they suck out blood of the incision. After 30 to 60 minutes they fall off and the wound -after a short time of after-bleeding- is bandaged up.

Also known as: Hirudo medicinalis, Leeching
Leech therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients from an outpatient clinic for naturopathy, traditional chinese and indian medicine(secondary care)

You may qualify if:

  • to 85 years of age
  • \>6 months thoracal postherpetic neuralgia
  • informed consent

You may not qualify if:

  • if leech therapy is contraindicated
  • physical and mental disability to participate in the study examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chair of Complementary and Integrative Medicine

Essen, 45276, Germany

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Leeching

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Romy Lauche, PhD

    Research fellow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 6, 2012

Study Start

September 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations

DE(1)