Trial record 7 of 22 for:
Open Studies | "Neuralgia, Postherpetic"
Leech Therapy for Postherpetic Neuralgia (ZoHir)
This study is currently recruiting participants.
Verified December 2012 by Universität Duisburg-Essen
Sponsor:
Universität Duisburg-Essen
Information provided by (Responsible Party):
Romy Lauche, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01744522
First received: December 5, 2012
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Postherpetic Neuralgia |
Procedure: Leech therapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pilot Study on the Influence of Leech Therapy on Pain and Sensory Processing in Patients With Postherpetic Neuralgia |
Resource links provided by NLM:
Further study details as provided by Universität Duisburg-Essen:
Primary Outcome Measures:
- 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)
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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:
|
Detailed Description:
see above
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients from an outpatient clinic for naturopathy, traditional chinese and indian medicine(secondary care)
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744522
Contacts
| Contact: Romy Lauche, PhD | +49201174 ext 25054 | r.lauche@kliniken-essen-mitte.de |
Locations
| Germany | |
| Chair of Complementary and Integrative Medicine | Recruiting |
| Essen, Germany, 45276 | |
| Contact: Romy Lauche, PhD +49201174 ext 25054 r.lauche@kliniken-essen-mitte.de | |
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
| Principal Investigator: | Romy Lauche, PhD | Research fellow |
More Information
No publications provided
| Responsible Party: | Romy Lauche, Principal Investigator, Universität Duisburg-Essen |
| ClinicalTrials.gov Identifier: | NCT01744522 History of Changes |
| Other Study ID Numbers: | 12-5147-BO |
| Study First Received: | December 5, 2012 |
| Last Updated: | December 6, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Neuralgia Neuralgia, Postherpetic Pain Neurologic Manifestations |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013