Herpes ZosterPhase 4ACUZosterNCT00885586
Acupuncture in Herpes Zoster Neuralgia (ACUZoster)
A Phase 4 study testing gabapentine and Acupuncture in people with Herpes Zoster and Postherpetic Neuralgia, run by Dominik Irnich at 1 site in Germany.
Trial summary
Symptoms that herald herpes zoster include pruritus, dysesthesia and pain along the distribution of the involved dermatome. The most distressing symptom is typically pain and the most feared complication is postherpetic neuralgia (PHN), the persistence of pain long after rash healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster, Postherpetic Neuralgia, Pain
- What is being tested?
- gabapentine and Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to 5 Apr 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of acute HZ
- Pain intensity > 30 mm visual analog scale
Who cannot join
- Patients with insulin-dependent diabetes mellitus or other diseases influencing the peripheral sensibility (e.g., polyneuropathia, chronic pain syndromes, cutaneous irritations i.e. burns)
- Patients under age
- Uncompliance
- Pregnancy or lactation
- Surgery within the last 3 month
- Severe heart/lung/kidney disease
Show all 11Show fewer
- Diseases influencing the quality of life
- Psychiatric diseases (e.g., depression, schizophrenia, dementia)
- Chronic intake of analgesics, neuroleptics, antidepressants, corticoids, alpha-agonists
- Acupuncture, transdermal electric neurostimulation or other Complementary and Alternative Medicine treatment within the last 4 weeks
- Contraindications according to the summary of product informations against analgesic treatment (i.e., metamizol, paracetamol, tramadol, morphine) or the investigational medicinal products (gabapentine, acupuncture needles)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Multidisciplinary Pain Unit, University of Munich
Munich, Bavaria, 80336
About this study
Official title: Analgetic Effectiveness of Acupuncture When Compared to a Standardised Analgesic Regimen in the Treatment of Herpes Zoster Neuralgia
Symptoms that herald herpes zoster include pruritus, dysesthesia and pain along the distribution of the involved dermatome. The most distressing symptom is typically pain and the most feared complication is postherpetic neuralgia (PHN), the persistence of pain long after rash healing. PHN is defined as pain persisting more than 3 months after the rash has healed. Both, the acute pain associated with herpes zoster and the chronic pain of PHN, have multiple adverse effects on health-related quality of life.
The primary objective of the trial presented is to investigate whether a 4 week semi-standardised acupuncture is non-inferior (first step) or superior (second step) to (a) the anticonvulsive drug gabapentin and (b) sham laser acupuncture in the treatment of pain associated with herpes zoster in addition to standardised analgesics. Secondary objectives include an assessment of the change of sensoric function, of long-term effectiveness, the occurrence of PHN and an evaluation of several pain specific questionnaires
- Conditions
- Herpes Zoster, Postherpetic Neuralgia, Pain
- Being tested
- Sham-laser acupuncture, gabapentine, Acupuncture
- Keywords
- herpes zoster, neuropathic pain, acupuncture, randomised controlled trial, acute herpes zoster
- Medical subject headings
- Herpes Zoster, Neuralgia, Postherpetic, Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham-laser acupunctureDevice
Laser irradiation is faked, approaching a non-functioning laser pen.
gabapentineDrug
Patients in this arm are treated individually with gabapentine 900 mg/d - 3600 mg/d, according to the recommended scheme given by the manufacturer
AcupunctureProcedure or surgery
The needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles.
| Study group | Role | What they receive |
|---|---|---|
| Sham-laser acupuncture | Sham comparator | Sham laser acupuncture (c) is applied at equivalent points as needle acupuncture. Laser irradiation is faked. Receives: Device: Sham-laser acupuncture |
| gabapentine | Active comparator | standard analgesic treatment Receives: Drug: gabapentine |
| Acupuncture | Active comparator | Acupuncture treatment is semi-standardized, i.e. beside a scheme of basic points, individual points can be chosen according to the TCM diagnostic pattern. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alteration of pain intensity after treatment
Measured: 5 weeks
Secondary outcomes (1)
Quantitative sensory testing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startNov 2008
- Primary completion29 Aug 2017
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dominik Irnich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dominik Irnich, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885586
- Sponsor's protocol ID
- AcuZoster Effectiveness 2006
- Acronym
- ACUZoster
- Status last verified
- Aug 2018
- First submitted
- 21 Apr 2009
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fleckenstein J, Kramer S, Hoffrogge P, Thoma S, Lang PM, Lehmeyer L, Schober GM, Pfab F, Ring J, Weisenseel P, Schotten KJ, Mansmann U, Irnich D. Acupuncture in acute herpes zoster pain therapy (ACUZoster) - design and protocol of a randomised controlled trial. BMC Complement Altern Med. 2009 Aug 12;9:31. doi: 10.1186/1472-6882-9-31.
PubMed 19674449
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgetic Effectiveness of Acupuncture When Compared to a Standardised Analgesic Regimen in the Treatment of Herpes Zoster Neuralgia
- ClinicalTrials.gov ID
- NCT00885586
- Acronym / sponsor ID
- ACUZoster / AcuZoster Effectiveness 2006
- Conditions
- Herpes Zoster, Postherpetic Neuralgia, Pain
- Keywords
- herpes zoster, neuropathic pain, acupuncture, randomised controlled trial, acute herpes zoster
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Dominik IrnichUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 22 Apr 2009 (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.
Symptoms that herald herpes zoster include pruritus, dysesthesia and pain along the distribution of the involved dermatome. The most distressing symptom is typically pain and the most feared complication is postherpetic neuralgia (PHN), the persistence of pain long after rash healing. PHN is defined as pain persisting more than 3 months after the rash has healed. Both, the acute pain associated with herpes zoster and the chronic pain of PHN, have multiple adverse effects on health-related quality of life.
The primary objective of the trial presented is to investigate whether a 4 week semi-standardised acupuncture is non-inferior (first step) or superior (second step) to (a) the anticonvulsive drug gabapentin and (b) sham laser acupuncture in the treatment of pain associated with herpes zoster in addition to standardised analgesics. Secondary objectives include an assessment of the change of sensoric function, of long-term effectiveness, the occurrence of PHN and an evaluation of several pain specific questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham-laser acupuncture | Sham comparator | Device: Sham-laser acupunctureSham laser acupuncture (c) is applied at equivalent points as needle acupuncture. Laser irradiation is faked. |
| gabapentine | Active comparator | Drug: gabapentinestandard analgesic treatment |
| Acupuncture | Active comparator | Procedure: AcupunctureAcupuncture treatment is semi-standardized, i.e. beside a scheme of basic points, individual points can be chosen according to the TCM diagnostic pattern. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of acute HZ
- Pain intensity > 30 mm visual analog scale
Key exclusion criteria (11 listed)
- Patients with insulin-dependent diabetes mellitus or other diseases influencing the peripheral sensibility (e.g., polyneuropathia, chronic pain syndromes, cutaneous irritations i.e. burns)
- Patients under age
- Uncompliance
- Pregnancy or lactation
- Surgery within the last 3 month
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 |
|---|---|---|
| Sham-laser acupunctureLaser irradiation is faked, approaching a non-functioning laser pen. | Device | Sham-laser acupuncture |
| gabapentinePatients in this arm are treated individually with gabapentine 900 mg/d - 3600 mg/d, according to the recommended scheme given by the manufacturer | Drug | gabapentine |
| AcupunctureThe needle acupuncture technique used in this trial is performed according the traditional way (TCM) using expendable needles. | Procedure or surgery | Acupuncture |
Primary outcome
Alteration of pain intensity after treatment
Time frame: 5 weeks
1 secondary outcome
Quantitative sensory testing
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Background: PubMed 19674449Fleckenstein J, Kramer S, Hoffrogge P, Thoma S, Lang PM, Lehmeyer L, Schober GM, Pfab F, Ring J, Weisenseel P, Schotten KJ, Mansmann U, Irnich D. Acupuncture in acute herpes zoster pain therapy (ACUZoster) - design and protocol of a randomised controlled trial. BMC Complement Altern Med. 2009 Aug 12;9:31. doi: 10.1186/1472-6882-9-31.
Related trials for Herpes Zoster
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gabapentine and Acupuncture in people with Herpes Zoster and Postherpetic Neuralgia, run by Dominik Irnich 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 10 Aug 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alteration of pain intensity after treatment (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00885586, which also lists 1 linked publication.
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 10 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.