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

NCT ID: NCT06344403

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-12-01

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.

Conditions

Herpes Zoster; Local Infiltration; Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard gorup

Patients will receive standard oral medicine for herpes zoster.

Group Type: ACTIVE_COMPARATOR

analgesic

Intervention Type: 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.

TPI group

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

Group Type: EXPERIMENTAL

analgesic

Intervention Type: 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.

Tender point infiltration

Intervention Type: BEHAVIORAL

Lidocaine mixed with diprospan injected into tender points.

Interventions

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.

Intervention Type: DRUG

Tender point infiltration

Lidocaine mixed with diprospan injected into tender points.

Intervention Type: BEHAVIORAL

Other Intervention Names

Standard treatment; TPI infiltration

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fang Luo

Director of Department of Pain Managrment

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fang Luo, M.D.

Role: STUDY_DIRECTOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

KY2024-045-02

Identifier Type: -

Identifier Source: org_study_id