Postherpetic NeuralgiaZoHirNCT01744522
Leech Therapy for Postherpetic Neuralgia
An observational study of Postherpetic Neuralgia, run by Universität Duisburg-Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- Leech therapy
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients from an outpatient clinic for naturopathy, traditional chinese and indian medicine(secondary care)
Who may be able to join
- 18 to 85 years of age
- >6 months thoracal postherpetic neuralgia
- informed consent
Who cannot join
- if leech therapy is contraindicated
- physical and mental disability to participate in the study examinations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
see above
- Conditions
- Postherpetic Neuralgia
- Being tested
- Leech therapy
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leech therapyProcedure or surgery
Also called Hirudo medicinalis, Leeching
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.
| Study group | Role | What they receive |
|---|---|---|
| Leech therapy | Patients receiving leech therapy in the outpatient clinic Receives: Procedure: Leech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity measured on a visual analogue scale (0-100mm, 100mm indicating worst pain imaginable)
Measured: 28 days
Secondary outcomes (10)
Pain intensity
pain intensity on a 100mm Visual Analogue Scale
Measured: 3 months
Pain quality
sensory and affective dimensions of pain (measured by the McGill Pain Questionnaire)
Measured: 28 Days
Pain quality
sensory and affective dimensions of pain (measured by the McGill Pain Questionnaire)
Measured: 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.)
Measured: 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.)
Measured: 3 months
Quality of life
quality of life measured by the SF36
Measured: 28 days
quality of life
quality of life measured by the SF36
Measured: 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.)
Measured: 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.)
Measured: 3 months
Safety
all adverse and serious adverse events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: We were not able to recruit enough patients for this study within a given time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romy Lauche, Universität Duisburg-Essen
- Investigators
- Romy Lauche, PhD, Principal investigator, Research fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744522
- Sponsor's protocol ID
- 12-5147-BO
- Acronym
- ZoHir
- Status last verified
- Apr 2014
- First submitted
- 5 Dec 2012
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Influence of Leech Therapy on Pain and Sensory Processing in Patients With Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT01744522
- Acronym / sponsor ID
- ZoHir / 12-5147-BO
- Conditions
- Postherpetic Neuralgia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We were not able to recruit enough patients for this study within a given time frame.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
see above
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leech therapy | – | Procedure: Leech therapyPatients receiving leech therapy in the outpatient clinic |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from an outpatient clinic for naturopathy, traditional chinese and indian medicine(secondary care)
Key inclusion criteria (3 listed)
- 18 to 85 years of age
- >6 months thoracal postherpetic neuralgia
- informed consent
Key exclusion criteria (2 listed)
- if leech therapy is contraindicated
- physical and mental disability to participate in the study examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leech therapyAlso: Hirudo medicinalis, LeechingLeech 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. | Procedure or surgery | Leech therapy |
Primary outcome
Pain intensity
Time frame: 28 days
Pain intensity measured on a visual analogue scale (0-100mm, 100mm indicating worst pain imaginable)
10 secondary outcomes
Pain intensity
Time frame: 3 months
Pain quality
Time frame: 28 Days
Pain quality
Time frame: 3 months
Impairment
Time frame: 28 days
Impairment
Time frame: 3 months
Quality of life
Time frame: 28 days
quality of life
Time frame: 3 months
Sensory perception and pain thresholds
Time frame: 28 days
Sensory perception and pain thresholds
Time frame: 3 months
Safety
Time frame: 28 days
Results and safety
The study was stopped early (reason given: We were not able to recruit enough patients for this study within a given time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romy Lauche, PhD principal investigator
Research fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postherpetic Neuralgia, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We were not able to recruit enough patients for this study within a given time frame.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2014.