Acute Pain Clinical Trial
Official title:
Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Management of Acute and Subacute Zoster Associated Pain
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital |
China,
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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