Clinical trial NCT06344403: Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Acute and Subacute Zoster Associated Pain
Official title: Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Management of Acute and Subacute Zoster Associated Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Herpes Zoster
Local Infiltration
Acute Pain
Keywords: Herpes zoster
Acute pain
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The presence of postherpetic neuralgia using VAS score
timeFrame: 12 months
Secondary outcomes:
measure: visual analogue scale score at each time point
timeFrame: 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
measure: Proportion of patients receiving repeated TPIs and block points
timeFrame: 12 months
measure: Consumption of oral drugs at each time point
timeFrame: day 1, then 2 weeks, 1 month, 3 months, 6 months and 12 months following the treatment.
measure: The presence of PHN 3 and month 6 post treatment
timeFrame: 3 and 6 months after treatments
measure: Patient satisfaction scores on the 5-point Likert scale
timeFrame: day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment
measure: Quality of life on the Scores on the WHOQOL-BREF
timeFrame: day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment
measure: Adverse reactions through study completion
timeFrame: After treatments
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo, M.D.
role: STUDY_DIRECTOR
References: