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

N/AActive Not RecruitingNCT06344403

Beijing Tiantan Hospital136 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

analgesicDRUG

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 infiltrationBEHAVIORAL

Lidocaine mixed with diprospan injected into tender points.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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"

Time frame: 12 months

Secondary Outcomes

visual analogue scale score at each time point

0 = 'no pain at all' to 10 = 'worst pain imaginable'

Time frame: 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

Time frame: 12 months

Consumption of oral drugs at each time point

Dose of celecoxib, pregabalin and tramadol

Time frame: day 1, then 2 weeks, 1 month, 3 months, 6 months and 12 months following the treatment.

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')

Time frame: 3 and 6 months after treatments

Patient satisfaction scores on the 5-point Likert scale

1: Very dissatisfied,2: Dissatisfied,3: Not sure,4: Satisfied,5: Very satisfied

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: month 12 posttreatment