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

Capital Medical University

Status: Active, not recruiting

Conditions: Local Infiltration; Acute Pain; Herpes Zoster

Treatments: Behavioral: Tender point infiltration; Drug: analgesic

Study type: Interventional

Funder types: Other

Identifiers

NCT06344403

KY2024-045-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Standard gorup

Active Comparator group

Description:

Patients will receive standard oral medicine for herpes zoster.

Treatment:

Drug: analgesic

TPI group

Experimental group

Description:

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

Treatment:

Drug: analgesic

Behavioral: Tender point infiltration