Pain Relief by Applying Transcutaneous Electrical Nerve Stimulation (TENS) During Transrectal Ultrasound Guided (TRUS) Prostate Biopsy: A Randomized Double-blind Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy pain relief of application of Acu-TENS in TRUS prostate biopsy
研究概览
简要总结
This study evaluates whether transcutaneous electrical nerve stimulation applied at specific acupuncture points (AcuTENS) can reduce pain and anxiety during transrectal ultrasound-guided prostate biopsy for participants suspected of prostate cancer. Many patients experience significant discomfort despite the use of periprostatic nerve block (PPNB).
The aim of this study is to determine whether AcuTENS provides additional pain relief or anxiety reduction beyond standard analgesia. The findings may help identify a simple, low-risk adjunct that can improve patient comfort during prostate biopsy. AcuTENS is a non-invasive technique that delivers mild electrical stimulation through the skin, targeting acupuncture points believed to modulate pain perception.
In this randomized, double-blind, placebo-controlled trial, participants are assigned to receive either active AcuTENS or a placebo TENS device that produces no therapeutic stimulation . All participants with receive routine care, including PPNB, according to institutional protocol. Pain scores, anxiety levels, vital signs, and patient satisfaction are recorded before, during, and after the biopsy.
详细描述
Transrectal ultrasound-guided prostate biopsy is the standard diagnostic procedure for suspected prostate cancer. Despite routine analgesic strategies such as periprostatic nerve block, many patients continue to experience moderate pain and procedure-related anxiety.
AcuTENS, a form of transcutaneous electrical nerve stimulation applied to acupuncture points, has shown potential benefits in chronic pain conditions, osteoarthritis, and procedural discomfort in small-scale studies. Its proposed mechanism involves activation of peripheral nerve fibers, endogenous opioid pathways, and autonomic modulation, leading to reduced pain perception and improved relaxation. However, high-quality randomized controlled data for its use during prostate biopsy are limited.
This study is a randomized, double-blind, placebo-controlled clinical trial conducted at University Malaya Medical Centre. The trial consists of two arms:
- Active AcuTENS: Electrical stimulation applied to predetermined acupuncture points before and during the biopsy.
- Placebo TENS: Identical device with no therapeutic electrical output.
An initial pilot phase involving 10 patients demonstrated that AcuTENS was feasible, safe, and potentially beneficial. This informed the development of the current definitive trial, which includes 53 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants and all study personnel, including clinicians performing the biopsy and assessors recording outcomes, are blinded to group allocation. Intervention devices are identical in appearance.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient consented for first time TRUS prostate biopsy.
- •Patient aged 18 years and above.
排除标准
- •Patient with previous experience of TRUS biopsy
- •Patient with pacemakers or automatic cardiac defibrillator implant or implant in the upper limb
- •Patient with cutaneous skin breaks on application sites (e.g wound, burn scar)
- •Patient diagnosed to have epilepsy or impaired mental state or anxiety disorder
- •Patient with known allergy to acupuncture patch or lidocaine spray
结局指标
主要结局
To evaluate the efficacy pain relief of application of Acu-TENS in TRUS prostate biopsy
时间窗: VAS scores will be recorded in real time at the moment of maximal discomfort during: Insertion of the transrectal ultrasound probe Injection of periprostatic local anaesthesia Prostate biopsy sampling Time Frame: Immediately during the procedure
Pain intensity will be assessed using the Visual Analogue Scale (VAS), a validated pain measurement tool ranging from 0 to 10, where: 0 = no pain 10 = worst pain imaginable Higher scores indicate greater pain intensity.
To evaluate the efficacy pain relief of application of Acu-TENS in TRUS prostate biopsy
时间窗: VAS scores will be recorded in real time at the moment of maximal discomfort during: Insertion of the transrectal ultrasound probe Injection of periprostatic local anaesthesia Prostate biopsy sampling Time Frame: Immediately during the procedure
Pain intensity will be assessed using the Visual Analogue Scale (VAS), a validated pain measurement tool ranging from 0 to 10, where: 0 = no pain 10 = worst pain imaginable Higher scores indicate greater pain intensity.
次要结局
- To evaluate anxiety levels of subjects undergoing TRUS biopsy with application of Acu-TENS(STAI scores will be measured: 1. Before the biopsy 2. Immediately after completion of the biopsy Time Frame: Pre-procedure and immediately post-procedure)
- To evaluate anxiety levels of subjects undergoing TRUS biopsy with application of Acu-TENS(STAI scores will be measured: 1. Before the biopsy 2. Immediately after completion of the biopsy Time Frame: Pre-procedure and immediately post-procedure)
研究者
Harshini Mahendran
Research Team member
University of Malaya