Leech Therapy for Postherpetic Neuralgia

Study Overview
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Brief Summary
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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.

Detailed Description
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see above

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

Conditions
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Postherpetic Neuralgia

Intervention / Treatment
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* Procedure: Leech therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Leech therapy<br>Patients receiving leech therapy in the outpatient clinic | Procedure: Leech therapy<br>* 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.<br>* Other names: Leeching;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity measured on a visual analogue scale (0-100mm, 100mm indicating worst pain imaginable) | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | pain intensity on a 100mm Visual Analogue Scale | 3 months | 
| Pain quality | sensory and affective dimensions of pain (measured by the McGill Pain Questionnaire) | 28 Days | 
| Pain quality | sensory and affective dimensions of pain (measured by the McGill Pain Questionnaire) | 3 months | 
| 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 | 
| 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 | 
| Quality of life | quality of life measured by the SF36 | 28 days | 
| quality of life | quality of life measured by the SF36 | 3 months | 
| 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 | 
| 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 | 
| Safety | all adverse and serious adverse events | 28 days |