Leech Therapy for Postherpetic Neuralgia (ZoHir)

This study has been terminated.
(We were not able to recruit enough patients for this study within a given time frame.)
Sponsor:
Information provided by (Responsible Party):
Romy Lauche, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01744522
First received: December 5, 2012
Last updated: April 10, 2014
Last verified: April 2014

December 5, 2012
April 10, 2014
September 2012
April 2014   (final data collection date for primary outcome measure)
Pain intensity [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Pain intensity measured on a visual analogue scale (0-100mm, 100mm indicating worst pain imaginable)
Same as current
Complete list of historical versions of study NCT01744522 on ClinicalTrials.gov Archive Site
  • Pain intensity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    pain intensity on a 100mm Visual Analogue Scale
  • Pain quality [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    sensory and affective dimensions of pain (measured by the McGill Pain Questionnaire)
  • Pain quality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    sensory and affective dimensions of pain (measured by the McGill Pain Questionnaire)
  • Impairment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    functional impairment due to zoster pain, measured bey the zoster brief pain inventory and the zoster impact questionnaire (Coplan P, Schmader K, Nikas A, Chan I, Choo P, Levin M, Johnson G, Bauer M, Williams HM, Kapla KM, Guess HA, Oxman MN. (2004). Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory. J Pain, 5(6), 344-356.)
  • Impairment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    functional impairment due to zoster pain, measured bey the zoster brief pain inventory and the zoster impact questionnaire (Coplan P, Schmader K, Nikas A, Chan I, Choo P, Levin M, Johnson G, Bauer M, Williams HM, Kapla KM, Guess HA, Oxman MN. (2004). Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory. J Pain, 5(6), 344-356.)
  • Quality of life [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    quality of life measured by the SF36
  • quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    quality of life measured by the SF36
  • Sensory perception and pain thresholds [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Sensory perception and pain thresholds measured by the quantitative sensory testing battery (Rolke, R., Magerl, W., Campbell, K. A., Schalber, C., Caspari, S., Birklein, F. and Treede, R.-D. (2006), Quantitative sensory testing: a comprehensive protocol for clinical trials. European Journal of Pain, 10: 77.)
  • Sensory perception and pain thresholds [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Sensory perception and pain thresholds measured by the quantitative sensory testing battery (Rolke, R., Magerl, W., Campbell, K. A., Schalber, C., Caspari, S., Birklein, F. and Treede, R.-D. (2006), Quantitative sensory testing: a comprehensive protocol for clinical trials. European Journal of Pain, 10: 77.)
  • Safety [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    all adverse and serious adverse events
Same as current
Not Provided
Not Provided
 
Leech Therapy for Postherpetic Neuralgia
Pilot Study on the Influence of Leech Therapy on Pain and Sensory Processing in Patients With Postherpetic Neuralgia

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.

see above

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Postherpetic Neuralgia
Procedure: Leech therapy
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.
Other Names:
  • Hirudo medicinalis
  • Leeching
Leech therapy
Patients receiving leech therapy in the outpatient clinic
Intervention: Procedure: Leech therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • if leech therapy is contraindicated
  • physical and mental disability to participate in the study examinations
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01744522
12-5147-BO
No
Romy Lauche, Universität Duisburg-Essen
Universität Duisburg-Essen
Not Provided
Principal Investigator: Romy Lauche, PhD Research fellow
Universität Duisburg-Essen
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP