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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06344403
Other study ID # KY2024-045-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date March 1, 2025

Study information

Verified date March 2024
Source Beijing Tiantan Hospital
Contact Fang Luo, M.D.
Phone 13611326978
Email 13611326978@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 136
Est. completion date March 1, 2025
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
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.
Behavioral:
Tender point infiltration
Lidocaine mixed with diprospan injected into tender points.

Locations

Country Name City State
China Beijing Tiantan Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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" 12 months
Secondary visual analogue scale score at each time point 0 = 'no pain at all' to 10 = 'worst pain imaginable' 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
Secondary Proportion of patients receiving repeated TPIs and block points Number of patients receiving TPI treatments more than twice/Number of all patients 12 months
Secondary Consumption of oral drugs at each time point Dose of celecoxib, pregabalin and tramadol day 1, then 2 weeks, 1 month, 3 months, 6 months and 12 months following the treatment.
Secondary The presence of PHN 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') 3 and 6 months after treatments
Secondary Patient satisfaction scores on the 5-point Likert scale 1: Very dissatisfied,2: Dissatisfied,3: Not sure,4: Satisfied,5: Very satisfied day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment
Secondary 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. day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment
Secondary Adverse reactions through study completion Any side effect and uncomfortable situation related to treatment through study completion,an average of 1 year After treatments
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