The Influence of Virtual Reality Approach on Phantom Pain in Trans Tibial Amputation: A Randomized Control Trail
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Pain Intensity Level
研究概览
简要总结
- To investigate the effect of Virtual reality (VR) on phantom limb pain in trans tibial amputation.
- To investigate the effect of Virtual reality (VR) on lower limb Function in trans tibial amputation.
A sample size of 60 will be randomly allocated to two groups(30 in each group) , by using computer-generated random number list method. Control group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) for reducing phantom pain in trans -tibial amputation and the experimental group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) and Virtual Reality for reducing phantom pain in trans -tibial amputation .
详细描述
Pain management has become an increasingly important healthcare concern in clinical practice.
The investigators use the phrase (phantom nerve pain) for pain described by patients related to the absence of sensation. Though simple numbness is often well-tolerated and not bothersome, phantom nerve pain develops for some patients.
The painful area is essentially numb yet painful, hence the term "anesthesia dolorosa," which translates as "painfully numb." In a similar way to amputees who have phantom limb pain (PLP) in a limb no longer present, patients with peripheral nerve injury can have phantom nerve pain in the denervated area. The investigators hypothesize that damage to the peripheral first-order neurons, along with spontaneously firing second-order neurons, causes this pain and, if not treated in a timely manner, results in cortical remodeling and centrally mediated pain (as in phantom limb pain).
Phantom limb pain (PLP) is experienced by 65-85% of limb amputees. In addition, a range of other sensations can originate in the missing limb including phantom limb awareness, phantom sensations (such as itching and pins and needles), and kinetic and kinesthetic sensations (movement and position in space). Traditionally the treatment target has been PLP; however, it has become clear over many years that treatment options have limited success.
Although in many cases these phenomena do not cause suffering, phantom limb- distortions often co-occur with phantom limb pain (PLP) , in other words, a painful sensation located in the phantom and thus outside the physical borders of the body. PLP is reported by the majority of amputees , accounts for a significant reduction in health-related quality of life and only insufficiently responds to conventional pharmacological interventions The large variation in symptomatology suggests a multifactorial origin of phantom phenomena. It has been shown that the amputation induces negative effects on peripheral and central physiological mechanisms, both contributing to the experience of phantom phenomena including PLP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 75 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants were prescreened older than 18 years; able to provide informed consent; with unilateral traumatic Factors Phantom Limb Pain lower limb amputation after complete recovery.
- •chronic PLP for more than 3 months.
- •If the subject was taking any medications, dosages must have been stable for at least 2 weeks before enrollment in the study.
- •Normal Body mass index ranged from 18.5 to 24.9.
排除标准
- •History of alcohol or drug abuse within the past 6 months.
- •Medical history of photophobia, epilepsy or any other light sensitivity.
- •Visual impairment thought to render the test invalid (people who need to wear glasses day to day are not excluded.
- •Uncontrolled epilepsy or prior seizures within the past year.
- •History of unexplained fainting spells or loss of consciousness as self-reported during the past 2 years.
- •Mirror therapy within 3 months prior to enrollment.
研究组 & 干预措施
Group1(Control )
Will receive conventional physiotherapy for one month and measure the pain intensity and lower extremity function
干预措施: Phantom Exercises (Other)
Group1(Control )
Will receive conventional physiotherapy for one month and measure the pain intensity and lower extremity function
干预措施: Mirroring Therapy (Device)
Group1(Control )
Will receive conventional physiotherapy for one month and measure the pain intensity and lower extremity function
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
Group2 (Experimental)
Will receive conventional physiotherapy and Virtual Reality for phantom Pain for one month and measure the pain intensity and lower extremity function
干预措施: Virtual Reality (Device)
Group2 (Experimental)
Will receive conventional physiotherapy and Virtual Reality for phantom Pain for one month and measure the pain intensity and lower extremity function
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
Group2 (Experimental)
Will receive conventional physiotherapy and Virtual Reality for phantom Pain for one month and measure the pain intensity and lower extremity function
干预措施: Mirroring Therapy (Device)
Group2 (Experimental)
Will receive conventional physiotherapy and Virtual Reality for phantom Pain for one month and measure the pain intensity and lower extremity function
干预措施: Phantom Exercises (Other)
结局指标
主要结局
Pain Intensity Level
时间窗: 4 weeks
Pain Intensity Level is measured by McGill Pain Questionnaire to determine the pain level The McGill Pain Questionnaire. The descriptors fall into four major groups: sensory (S)1-10, affective (A) 11-15, evaluative (E), 16 and miscellaneous (M)17-20. The rank value for each descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PRI). The present pain intensity (PPI) is based on a scale of (0-5) 0 refers to no pain and 5 refers to worst pain and know the effectiveness of the Virtual Reality wither pain is increased or decreased .
Lower Extremity Functional
时间窗: 4 weeks
Lower Extremity Functional is measured by Lower Extremity Functional Scale (LEFS) to know the progress of patient movement and balance.It is divided to 5 categories; 0 indicates extreme difficult or unable to perform activity, 1 indicates quite a bit of difficulty, 2 indicates moderate difficulty, 3 indicates a little bit of difficulty, 4 indicates no difficulty
次要结局
未报告次要终点
研究者
Mohamed Medhat Helal Mohamed
physiotherapy partctitioner
Cairo University
