Leech Therapy for Postherpetic Neuralgia

Postherpetic Neuralgia Clinical Trial

— ZoHir  

Official title:

Pilot Study on the Influence of Leech Therapy on Pain and Sensory Processing in Patients With Postherpetic Neuralgia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01744522
• Other study ID #: 12-5147-BO
• Status: Terminated
• Phase: N/A
• First received: December 5, 2012
• Last updated: April 10, 2014
• Start date: September 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

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.

Locations

Country	Name	City	State
Germany	Chair of Complementary and Integrative Medicine	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity measured on a visual analogue scale (0-100mm, 100mm indicating worst pain imaginable)	28 days	No
Secondary	Pain intensity	pain intensity on a 100mm Visual Analogue Scale	3 months	No
Secondary	Pain quality	sensory and affective dimensions of pain (measured by the McGill Pain Questionnaire)	28 Days	No
Secondary	Pain quality	sensory and affective dimensions of pain (measured by the McGill Pain Questionnaire)	3 months	No
Secondary	Impairment	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.)	28 days	No
Secondary	Impairment	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.)	3 months	No
Secondary	Quality of life	quality of life measured by the SF36	28 days	No
Secondary	quality of life	quality of life measured by the SF36	3 months	No
Secondary	Sensory perception and pain thresholds	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.)	28 days	No
Secondary	Sensory perception and pain thresholds	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.)	3 months	No
Secondary	Safety	all adverse and serious adverse events	28 days	Yes