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

NCT06344403 | Active Not Recruiting DMC

• 1 other identifier: KY2024-045-02
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Herpes Zoster; Local Infiltration; Acute Pain

Keywords

Herpes zoster; Acute pain

Outcome Measures

Primary Outcomes (1)

• 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"

  12 months

Secondary Outcomes (8)

• visual analogue scale score at each time point

  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

  12 months

• Consumption of oral drugs at each time point

  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

  3 and 6 months after treatments

• Patient satisfaction scores on the 5-point Likert scale

  day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment

Study Arms (2)

Standard gorup

ACTIVE COMPARATOR

Patients will receive standard oral medicine for herpes zoster.

Drug: analgesic

TPI group

EXPERIMENTAL

Patients will receive standard medicine treatment and tender point infiltrations therapy.

Drug: analgesic; Behavioral: Tender point infiltration

Interventions

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.

Also known as: Standard treatment

Standard gorup; TPI group

Tender point infiltration BEHAVIORAL

Lidocaine mixed with diprospan injected into tender points.

Also known as: TPI infiltration

TPI group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Herpes Zoster; Acute Pain

Interventions

Analgesics

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Fang Luo, M.D.

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Managrment

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 3, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CN (1)