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临床试验/CTRI/2025/03/081851
CTRI/2025/03/081851进行中(未招募)不适用

Comparing the effect of Virtual Reality and Pregabalin on Neuropathic pain over only Pregabalin in Traumatic Spinal Cord Injury: A Randomized Controlled Trial

Department of PMRAIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月9日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
Brief Pain Inventory Scale (Short Form)

研究概览

简要总结

Spinal cord injury (SCI) is an injury to spinal cord leading to motor and/or sensory deficits [1] and by definition excludes isolated injuries to nerve roots [2], may cause function loss, autonomic disturbances and increased morbidity & mortality.

Pain is commonly reported in SCI patients, mainly neuropathic pain [3] Hypothesised that neuropathic pain below and at level of spinal injury is due to exaggerated neuronal responses to stimuli below normal thresholds.[4] The hyperexcitability is due to altered ion receptors and channels, decreased endogenous inhibitory neurons in dorsal horn.[5] Another theory includes changes at supraspinal level like neuroplasticity with primary somatosensory cortex reorganisation. [6-8] Neuropathic pain is also associated with functional changes in thalamus with animal studies showing abnormal patterns of firing in it. [9].

International Association for Study of Pain Neuropathic Pain Special Interest Group [10], recommend pregabalin as first-line treatment for neuropathic pain (NeP), alongside other drugs like tricyclic antidepressants, serotonin–noradrenaline reuptake inhibitors, and gabapentin [11]. The dose for treatment of NeP starts at 150 mg divided into two (BID) or three (TID) doses per day, increasing to 300 mg/day depending on therapeutic indication, increasing to a maximum of 600 mg/day.[12]

In clinical practice however patient may develop early side effects even with 150 mg/day, likely leading to therapy discontinuation so recommendation for low dose, and slowly titrating to therapeutic dose (termed ‘low and slow’ approach) is given [13] with starting dose as low as 25 mg/day (in elderly or frail patients) or 50 mg/day.

Virtual Reality (VR) is a simulated construction of 3D environment using computer and artificial intelligence technology. Current VR systems include head-mounted devices with 3D-glasses, sensory input devices, noise cancellation headphones, body-tracking sensors and input devices like joysticks,[13] forming a multisystem device giving realistic multisensory experience. Technological improvements in VR, offer an alternative solution of several medical conditions and show promise in improving symptoms like pain reduction in short and long term.[13]

The processes underlying effect of VR on pain have been broadly divided into two main types: distraction and neuroplasticity [14] and are believed to contribute to the analgesic effect of VR.

Distraction refers to the short-term diversion of attention away from pain towards an alternative stimulus. VR may act directly and indirectly to reduce pain by “hijacking” of attention, emotion and memory as well as visual, auditory and touch senses.[14] Neuroplasticity contributes to the effects of VR by long-term structural changes in neurons by involving in interactive real-time simulations of scenes or activities, leading to neuroplastic alterations in sensory and motor brain regions.[15]

In clinical practice however patients on pregabalin for neuropathic pain may develop early side effects even with recommended dose of 150 mg/day given over two doses a day. The adverse effects can range from somnolence, oedema, visual disturbances, ataxia, vertigo and euphoria and can likely lead to reason for therapy discontinuation. VR can provide an alternative to current pharmacologic treatment and can be used in addition to pregabalin for neuropathic pain to minimise its side effects, allowing starting dose to be as low as 25 mg/day (in elderly or frail patients) or 50 mg/day, and slowly titrating to therapeutic dose (termed ‘low and slow’ approach) [13]

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Complaints of neuropathic Pain Diagnosed as Traumatic Spinal Cord Injury Duration of injury more than 3 months.

排除标准

  • Patient with known pregabalin hypersensitivity or with product specific ingredient hypersensitivity.
  • Pregnant and Breastfeeding women.
  • Significant visual or hearing impairment.
  • Severe headache that may impact VR training.
  • Uncontrolled Hypertension Systolic more than 200 mmHg, Diastolic more than 110 mmHg.
  • Uncontrolled Seizures.
  • Any psychiatric illness leading to inability to follow commands completely.

结局指标

主要结局

Brief Pain Inventory Scale (Short Form)

时间窗: Day 0(Baseline), Day 15, Day 45

次要结局

  • Spinal Cord Independence Measure (SCIM)(Day 0, Day 15, Day 45)

研究者

发起方
Department of PMRAIIMS Rishikesh
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Raj Kumar Yadav

AIIMS Rishikesh

研究点 (1)

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