Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Management of Acute and Subacute Zoster Associated Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- The presence of postherpetic neuralgia using VAS score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with onset of HZ rash less than 90 days.
- •HZ affected the spinal nerves (cervical/thoracic/lumbar nerve).
- •Aged 18 to 75 years (inclusive).
- •Pain intensity > 7 cm on a visual analogue scale (VAS 0-10 cm).
- •Agreed to sign the informed consent form.
排除标准
- •Infection at the puncture site.
- •Poor general situation unable to be treated.
- •A history of abuse of narcotics.
- •Non-compliance or inability to complete the self-evaluation questionnaires.
- •Pregnancy or lactation.
- •Patients using immunosuppressants and those with severe systemic diseases such as hematological malignancies, cancers, or autoimmune disorders.
研究组 & 干预措施
Standard gorup
Patients will receive standard oral medicine for herpes zoster.
干预措施: analgesic (Drug)
TPI group
Patients will receive standard medicine treatment and tender point infiltrations therapy.
干预措施: analgesic (Drug)
TPI group
Patients will receive standard medicine treatment and tender point infiltrations therapy.
干预措施: Tender point infiltration (Behavioral)
结局指标
主要结局
The presence of postherpetic neuralgia using VAS score
时间窗: 12 months
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"
次要结局
- visual analogue scale score at each time point(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(12 months)
- Consumption of oral drugs at each time point(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(3 and 6 months after treatments)
- Patient satisfaction scores on the 5-point Likert scale(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(day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment)
- Adverse reactions through study completion(After treatments)
- Predictive factors for the prevention of PHN at month 12 posttreatment(month 12 posttreatment)
研究者
Fang Luo
Director of Department of Pain Managrment
Beijing Tiantan Hospital