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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
  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


Enrollment: 6
Study Start Date: September 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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:
  • Hirudo medicinalis
  • Leeching

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744522

Locations
Germany
Chair of Complementary and Integrative Medicine
Essen, Germany, 45276
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: April 10, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014