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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Pain; Herpes Zoster; Local Infiltration
• Intervention / Treatment: Drug: analgesic; Behavioral: Tender point infiltration

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 Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with onset of HZ rash less than 90 days.
2. HZ affected the spinal nerves (cervical/thoracic/lumbar nerve).
3. Aged 18 to 75 years (inclusive).
4. Pain intensity > 7 cm on a visual analogue scale (VAS 0-10 cm).
5. Agreed to sign the informed consent form.

Exclusion Criteria:

1. Infection at the puncture site.
2. Poor general situation unable to be treated.
3. A history of abuse of narcotics.
4. Non-compliance or inability to complete the self-evaluation questionnaires.
5. Pregnancy or lactation.
6. Patients using immunosuppressants and those with severe systemic diseases such as hematological malignancies, cancers, or autoimmune disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard gorup; Patients will receive standard oral medicine for herpes zoster.	Drug: analgesic; 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
Experimental: TPI group; Patients will receive standard medicine treatment and tender point infiltrations therapy.	Drug: analgesic; 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; Behavioral: Tender point infiltration; Lidocaine mixed with diprospan injected into tender points.; Other Names: TPI infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale score at each time point	0 = 'no pain at all' to 10 = 'worst pain imaginable'	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	12 months
Consumption of oral drugs at each time point	Dose of celecoxib, pregabalin and tramadol	day 1, then 2 weeks, 1 month, 3 months, 6 months and 12 months following the treatment.
Patient satisfaction scores on the 5-point Likert scale	1: Very dissatisfied,2: Dissatisfied,3: Not sure,4: Satisfied,5: Very satisfied	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.	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	After treatments
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')	3 and 6 months 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.	month 12 posttreatment

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Study Director: Fang Luo, M.D., Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Acute pain; Herpes zoster
• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Pain; Neurologic Manifestations; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Acute Pain; Herpes Zoster; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Central Nervous System Agents; Analgesics
• Other Study ID Numbers: KY2024-045-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No