An interventional study of analgesic and Tender point infiltration in Herpes Zoster, Local Infiltration and Acute Pain, sponsored by Beijing Tiantan Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
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.
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.
360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.
This study's planned enrollment of 136 is below the median of 250 across 299 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
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Exclusion Criteria:
Patients will receive standard oral medicine for herpes zoster.
Drug: analgesic
Patients will receive standard medicine treatment and tender point infiltrations therapy.
Drug: analgesic · Behavioral: Tender point infiltration
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.
Also known as: Standard treatment
Lidocaine mixed with diprospan injected into tender points.
Also known as: TPI infiltration
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"
Time frame: 12 months
visual analogue scale score at each time point
0 = 'no pain at all' to 10 = 'worst pain imaginable'
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
Number of patients receiving TPI treatments more than twice/Number of all patients
Time frame: 12 months
Consumption of oral drugs at each time point
Dose of celecoxib, pregabalin and tramadol
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
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')
Time frame: 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
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
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.
Time frame: 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
Time frame: 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.
Time frame: month 12 posttreatment
Plan to share: 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.
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Beijing Tiantan Hospital