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

Not Applicable

Recruiting

• Conditions: Herpes Zoster; Local Infiltration; Acute Pain
• Interventions: Drug: analgesic; Behavioral: Tender point infiltration

• Registration Number: NCT06344403
• Lead Sponsor: Beijing Tiantan Hospital

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.

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 Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-04-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2024-10-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard gorup	analgesic	Patients will receive standard oral medicine for herpes zoster.
TPI group	analgesic	Patients will receive standard medicine treatment and tender point infiltrations therapy.
TPI group	Tender point infiltration	Patients will receive standard medicine treatment and tender point infiltrations therapy.

Primary Outcome Measures

Name	Time	Method
The presence of postherpetic neuralgia using VAS score	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 Outcome Measures

Name	Time	Method
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	0 = 'no pain at all' to 10 = 'worst pain imaginable'
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.	Dose of celecoxib, pregabalin and tramadol
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	1: Very dissatisfied,2: Dissatisfied,3: Not sure,4: Satisfied,5: Very satisfied
Quality of life on the Scores on the WHOQOL-BREF	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.
Adverse reactions through study completion	After treatments	Any side effect and uncomfortable situation related to treatment through study completion，an average of 1 year
Proportion of patients receiving repeated TPIs and block points	12 months	Number of patients receiving TPI treatments more than twice/Number of all patients
The presence of PHN 3 and month 6 post treatment	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')

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China