Herpes ZosterNCT06344403
Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Acute and Subacute Zoster Associated Pain
A study testing analgesic and Tender point infiltration in people with Herpes Zoster and Local Infiltration, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Herpes zoster (HZ) is a skin infection disease which cause severe zoster-associated pain (ZAP) along sensory nerve in the corresponding segment. Evidence for the efficacy of existing local therapies for acute/subacute ZAP is limited. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Herpes Zoster, Local Infiltration, Acute Pain
- What is being tested?
- analgesic and Tender point infiltration
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with onset of HZ rash less than 90 days.
- HZ affected the spinal nerves (cervical/thoracic/lumbar nerve).
- Aged 18 to 75 years (inclusive).
- Pain intensity > 7 cm on a visual analogue scale (VAS 0-10 cm).
- Agreed to sign the informed consent form.
Who cannot join
- Infection at the puncture site.
- Poor general situation unable to be treated.
- A history of abuse of narcotics.
- Non-compliance or inability to complete the self-evaluation questionnaires.
- Pregnancy or lactation.
- Patients using immunosuppressants and those with severe systemic diseases such as hematological malignancies, cancers, or autoimmune disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Management of Acute and Subacute Zoster Associated Pain
Herpes zoster (HZ) is a skin infection disease which cause severe zoster-associated pain (ZAP) along sensory nerve in the corresponding segment. Evidence for the efficacy of existing local therapies for acute/subacute ZAP is limited. The hypothesis is that patients with acute/subacute ZAP treated with TPIs with local anesthetic and steroids under the basis of standard treatment will show better clinical outcomes compared with subjects treated with standard antiviral medicine treatment only.
Read the detailed description
The conventional therapies for HZ infection can be seen in two phases. Those in acute phase are mainly antiviral (acyclovir, famciclovir, etc.), analgesic drugs (opioids, acetaminophen or nonsteroidal anti-inflammatory agents, gabapentin, etc.), while these conventional drug therapies could yield potential side effects, and part of patients are not fully satisfied with the analgesic effect. It is considered that supplementary and alternative local therapies may have better results with less side effects and reduce medical costs to relieve pain associated with HZ infection. These options, including nerve blockade (epidural injection, paravertebral injection, sympathetic block, intercostal nerve block, intracutaneous injection), pulsed radiofrequency16, acupuncture, fire needling acupuncture, electrical nerve stimulation19, lidocaine patch, capsaicin cream, and botulinum toxin injection have been reported to give positive therapeutic effects on acute herpes zoster neuralgia (AHN), however, evidence for the efficacy of existing local therapies is limited and risks may occur due to high invasiveness of some procedures, there is insufficient evidence and expert agreement to make recommendations for these intervention strategies as first-line treatments in guidelines.
- Conditions
- Herpes Zoster, Local Infiltration, Acute Pain
- Being tested
- analgesic, Tender point infiltration
- Keywords
- Herpes zoster, Acute pain
- Medical subject headings
- Herpes Zoster, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analgesicDrug
Also called Standard treatment
Patients will receive daily 300 mg pregabalin in divided doses (150 mg/12 hours). Once the patient report mild pain (VAS ≤ 3), the trial for reducing the pregabalin dose will be done. Nonsteroidal anti-inflammatory drug celecoxib (200 mg on request, up to two times daily)27 and tramadol (100 mg on request, up to 400mg daily) will be available for as-needed analgesia.
Tender point infiltrationBehavioural
Also called TPI infiltration
Lidocaine mixed with diprospan injected into tender points.
| Study group | Role | What they receive |
|---|---|---|
| Standard gorup | Active comparator | Patients will receive standard oral medicine for herpes zoster. Receives: Drug: analgesic |
| TPI group | Experimental | Patients will receive standard medicine treatment and tender point infiltrations therapy. Receives: Drug: analgesic; Behavioral: Tender point infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of postherpetic neuralgia using VAS score
12 months after the treatments, number of patients with any pain with a VAS score of higher than 0/Number of all patients，0="no pain" and 10="worst pain imaginable"
Measured: 12 months
Secondary outcomes (8)
visual analogue scale score at each time point
0 = 'no pain at all' to 10 = 'worst pain imaginable'
Measured: before the treatment (baseline), 30min after the intervention (for TPI group), then 1 day, 2 weeks, 1 month, 3 months, 6 months and 12 months following the treatment
Proportion of patients receiving repeated TPIs and block points
Number of patients receiving TPI treatments more than twice/Number of all patients
Measured: 12 months
Consumption of oral drugs at each time point
Dose of celecoxib, pregabalin and tramadol
Measured: day 1, then 2 weeks, 1 month, 3 months, 6 months and 12 months following the treatment.
The presence of PHN at month 3 and month 6 post treatment
Number of patients with any pain with a VAS score of higher than 0/Number of all patients (0 = 'no pain at all' to 10 = 'worst pain imaginable')
Measured: 3 and 6 months after treatments
Patient satisfaction scores on the 5-point Likert scale
1: Very dissatisfied,2: Dissatisfied,3: Not sure,4: Satisfied,5: Very satisfied
Measured: day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment
Quality of life on the Scores on the WHOQOL-BREF
Scores on the WHOQOL-BREF. The responses are given on 5-point Likert scale (1-5) and the overall score ranges from 0 to 100; a higher score corresponds to better QoL.
Measured: day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment
Adverse reactions through study completion
Any side effect and uncomfortable situation related to treatment through study completion，an average of 1 year
Measured: After treatments
Predictive factors for the prevention of PHN at month 12 posttreatment
the correlation between patients' baseline characteristics and the incidence of PHN will be analyzed 12 months after treatment in TPI group.
Measured: month 12 posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Jun 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
- Investigators
- Fang Luo, M.D., Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344403
- Sponsor's protocol ID
- KY2024-045-02
- Status last verified
- Aug 2025
- First submitted
- 17 Mar 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Management of Acute and Subacute Zoster Associated Pain
- ClinicalTrials.gov ID
- NCT06344403
- Acronym / sponsor ID
- KY2024-045-02
- Conditions
- Herpes Zoster, Local Infiltration, Acute Pain
- Keywords
- Herpes zoster, Acute pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Apr 2024 (actual)
- 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.
Herpes zoster (HZ) is a skin infection disease which cause severe zoster-associated pain (ZAP) along sensory nerve in the corresponding segment. Evidence for the efficacy of existing local therapies for acute/subacute ZAP is limited. The hypothesis is that patients with acute/subacute ZAP treated with TPIs with local anesthetic and steroids under the basis of standard treatment will show better clinical outcomes compared with subjects treated with standard antiviral medicine treatment only.
Detailed description
The conventional therapies for HZ infection can be seen in two phases. Those in acute phase are mainly antiviral (acyclovir, famciclovir, etc.), analgesic drugs (opioids, acetaminophen or nonsteroidal anti-inflammatory agents, gabapentin, etc.), while these conventional drug therapies could yield potential side effects, and part of patients are not fully satisfied with the analgesic effect. It is considered that supplementary and alternative local therapies may have better results with less side effects and reduce medical costs to relieve pain associated with HZ infection. These options, including nerve blockade (epidural injection, paravertebral injection, sympathetic block, intercostal nerve block, intracutaneous injection), pulsed radiofrequency16, acupuncture, fire needling acupuncture, electrical nerve stimulation19, lidocaine patch, capsaicin cream, and botulinum toxin injection have been reported to give positive therapeutic effects on acute herpes zoster neuralgia (AHN), however, evidence for the efficacy of existing local therapies is limited and risks may occur due to high invasiveness of some procedures, there is insufficient evidence and expert agreement to make recommendations for these intervention strategies as first-line treatments in guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard gorup | Active comparator | Drug: analgesicPatients will receive standard oral medicine for herpes zoster. |
| TPI group | Experimental | Drug: analgesic, Behavioral: Tender point infiltrationPatients will receive standard medicine treatment and tender point infiltrations therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with onset of HZ rash less than 90 days.
- HZ affected the spinal nerves (cervical/thoracic/lumbar nerve).
- Aged 18 to 75 years (inclusive).
- Pain intensity > 7 cm on a visual analogue scale (VAS 0-10 cm).
- Agreed to sign the informed consent form.
Key exclusion criteria (6 listed)
- Infection at the puncture site.
- Poor general situation unable to be treated.
- A history of abuse of narcotics.
- Non-compliance or inability to complete the self-evaluation questionnaires.
- Pregnancy or lactation.
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 |
|---|---|---|
| analgesicAlso: Standard treatmentPatients will receive daily 300 mg pregabalin in divided doses (150 mg/12 hours). Once the patient report mild pain (VAS ≤ 3), the trial for reducing the pregabalin dose will be done. Nonsteroidal anti-inflammatory drug celecoxib (200 mg on request, up to two times daily)27 and tramadol (100 mg on request, up to 400mg daily) will be available for as-needed analgesia. | Drug | Standard gorup, TPI group |
| Tender point infiltrationAlso: TPI infiltrationLidocaine mixed with diprospan injected into tender points. | Behavioural | TPI group |
Primary outcome
The presence of postherpetic neuralgia using VAS score
Time frame: 12 months
12 months after the treatments, number of patients with any pain with a VAS score of higher than 0/Number of all patients，0="no pain" and 10="worst pain imaginable"
8 secondary outcomes
visual analogue scale score at each time point
Time frame: before the treatment (baseline), 30min after the intervention (for TPI group), then 1 day, 2 weeks, 1 month, 3 months, 6 months and 12 months following the treatment
Proportion of patients receiving repeated TPIs and block points
Time frame: 12 months
Consumption of oral drugs at each time point
Time frame: day 1, then 2 weeks, 1 month, 3 months, 6 months and 12 months following the treatment.
The presence of PHN at month 3 and month 6 post treatment
Time frame: 3 and 6 months after treatments
Patient satisfaction scores on the 5-point Likert scale
Time frame: day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment
Quality of life on the Scores on the WHOQOL-BREF
Time frame: day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment
Adverse reactions through study completion
Time frame: After treatments
Predictive factors for the prevention of PHN at month 12 posttreatment
Time frame: month 12 posttreatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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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.
Fang Luo, M.D. study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing analgesic and Tender point infiltration in people with Herpes Zoster and Local Infiltration, run by Beijing Tiantan Hospital at 1 site in China.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
The presence of postherpetic neuralgia using VAS score (time frame: 12 months). 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 5 Sep 2025.