Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06344403

Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Herpes Zoster Acute Pain DNA Virus Infections Herpesviridae Infections Infections Local Infiltration Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Varicella Zoster Virus Infection Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Analgesic

Drug

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.

Other names: Standard treatment

Tender point infiltration

Behavioral

Lidocaine mixed with diprospan injected into tender points.

Other names: TPI infiltration

Primary outcomes

  1. 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"

Secondary outcomes

  1. 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

    0 = 'no pain at all' to 10 = 'worst pain imaginable'

  2. Proportion of patients receiving repeated TPIs and block points

    Time frame: 12 months

    Number of patients receiving TPI treatments more than twice/Number of all patients

  3. 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.

    Dose of celecoxib, pregabalin and tramadol

  4. The presence of PHN at month 3 and month 6 post treatment

    Time frame: 3 and 6 months after treatments

    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')

  5. 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

    1: Very dissatisfied,2: Dissatisfied,3: Not sure,4: Satisfied,5: Very satisfied

  6. 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

    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.

  7. Adverse reactions through study completion

    Time frame: After treatments

    Any side effect and uncomfortable situation related to treatment through study completion，an average of 1 year

  8. Predictive factors for the prevention of PHN at month 12 posttreatment

    Time frame: month 12 posttreatment

    the correlation between patients' baseline characteristics and the incidence of PHN will be analyzed 12 months after treatment in TPI group.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Management of Acute and Subacute Zoster Associated Pain

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 3, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.