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临床试验/CTRI/2025/07/091513
CTRI/2025/07/091513已完成4 期

Efficacy of cold vs vibratory analgesia for pain relief in Platelet-Rich Plasma therapy: a randomized split scalp study

Dr Rudrani Mukherjee1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年8月4日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Comparison between mean Pain Scores using the Visual Analogue Scale of Cold versus Vibratory analgesia during PRP

研究概览

简要总结

This randomized, split-scalp clinical trial aims to compare the analgesic efficacy of cold versus vibratory analgesia during platelet-rich plasma (PRP) injections over the scalp for conditions including androgenetic alopecia, telogen effluvium. Fifty-two adult patients undergoing PRP as a standard of care, will receive 2 different analgesia methods - cold analgesia (ice pack) on one half of the scalp and vibratory analgesia using a kinetic anesthetic device (KAD) on the other. Side allocation will be randomized using a computer-generated list, with allocation concealed and the statistician blinded to the intervention.

Pain will be measured immediately after each side using a Visual Analogue Scale (VAS), and ease of administration will be assessed by the performing dermatology residents using a structured Ease of Administration questionnaire. Statistical analysis will include paired t-tests for continuous variables and McNemar’s test for categorical outcomes.

The study is designed to evaluate both patient-reported pain relief and clinician-reported feasibility of each analgesic method. Risk mitigation includes immediate discontinuation of the analgesic method if adverse reactions occur, with symptomatic management provided. Results will inform evidence-based, non-pharmacological pain management during PRP therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • People aged 18 years or more than 18 years undergoing scalp Platelet Rich Plasma therapy
  • Willingness to receive either cold therapy or vibratory analgesia as a pain management technique during PRP
  • Intact scalp sensation
  • Ability to provide informed consent and comply with study protocols, including pain assessments.

排除标准

  • Contraindications to cold therapy including previous history of Raynaud’s disease or phenomenon, cold urticaria, cryoglobulinemia
  • Use of systemic or local analgesics, anesthetics, or sedatives within 24 hours before PRP injection
  • Neurological disorders affecting scalp sensation including scalp neuropathy, trigeminal neuralgia
  • Active scalp infections
  • Pregnant or lactating patients
  • Cognitive impairment, psychiatric disorders, or communication barriers preventing accurate pain reporting.

结局指标

主要结局

Comparison between mean Pain Scores using the Visual Analogue Scale of Cold versus Vibratory analgesia during PRP

时间窗: 6 months

次要结局

  • Assessment and comparison of mean Ease of Administration Scores using the Likert Scale for Cold versus Vibratory analgesia during PRP(6 months)

研究者

发起方
Dr Rudrani Mukherjee
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Rudrani Mukherjee

Kasturba Medical College Manipal

研究点 (1)

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