Leech Therapy for Postherpetic Neuralgia (ZoHir)

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.

Study Overview

• Status: Terminated
• Conditions: Postherpetic Neuralgia
• Intervention / Treatment: Procedure: Leech therapy

Detailed Description

see above

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45276
    • Chair of Complementary and Integrative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Leech therapy; Patients receiving leech therapy in the outpatient clinic	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Principal Investigator: Romy Lauche, PhD, Research Fellow

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): April 11, 2014
• Last Update Submitted That Met QC Criteria: April 10, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic
• Other Study ID Numbers: 12-5147-BO