Effects of Phantom Exercises on Pain, Mobility and Quality of Life Among Lower Limb Amputees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Visual analogue scale (VAS)
研究概览
简要总结
In this research, the aim is to find out the effects of phantom exercises in terms of pain, mobility and quality of life among lower-limb amputees having phantom limb pain. This is a randomized control trial in which amputees having phantom limb pain will be randomly divided into two groups i.e. Experimental group (Routine physical therapy, mirror therapy and phantom exercises) and control group (Routine physical therapy and mirror therapy). Non-probability purposive sampling technique will be employed. Patients of age between 18 to 50 years and having phantom limb pain after lower limb amputation will be recruited by evaluating with limb deficiency and phantom limb questionnaire. Other tools will be Visual analogue scale (pain), Amputee mobility predictor (Ambulatory status) and 36-Item Short-Form Health Survey questionnaire (Health-related quality of life). The study will be conducted in 6 months and data obtained will be analyzed through Statistical Package for Social Sciences (SPSS) 20.
详细描述
An amputation is a distressing event that will result in physical, psychological, and social consequences. The loss of limb means a huge impact, not only for the patient's body and the way he notices it, as well as the perception of the environment around him. Most of the patients with lower extremity amputations experienced phantom limb pain. It is defined by painful sensation in the missing limb. According to a recent study, the prevalence of phantom limb pain ranges from 45% to 85%. Regardless of the reason for amputation, phantom limb pain diminishes over time in most cases. However, in about 5-10% of amputees' severe pain persists for several years. It affects the patient's capacity for self-care and personal independence as it is mentally and physically debilitating. Incidence of PLP in recent studies is reported to be approximately 42.2-78.8% of amputees. It should be noted that phantom limb pain (PLP) differs from pain in the stump called residual limb pain (RLP), which is due to skin complications, vascular compromise, inappropriate healing, painful neuromas, excess soft tissue and bone irregularities.
However, the exact mechanism of phantom limb pain is unknown, but advancement in pain physiology indicates that multiple mechanisms are involved including peripheral, spinal and supraspinal mechanisms. The first changes may take place in the periphery where the nerve endings are sensitized by pre-amputation pain and nerve transection. But the complexity of phantom phenomena and the association between catastrophizing and phantom limb pain indicate that supraspinal changes play a significant role in phantom pain. It is likely that the relative contributions of these mechanisms vary from one amputee to another and that they may change over time in the individual patient.
It has been seen that phantom limb pain is typically experienced in regions with large cortical representation, such as the hands/fingers and feet/toes. The pain is often described with words such as knifelike, sticking, pricking, shooting, and burning. Both PLP and RLP have a high incidence among amputees. These pains are a continual reminder of circumstances and can affect important factors of Quality of life such as sleep, fatigue mood and relationships compromising the acquisition of skills and quality of life. Thus, interfering with the physical and psychosocial rehabilitation of the amputee. This should be considered clinically during therapeutic encounters, and amputees should be given appropriate information on these potential associations, though often neglected by the medical team. Although QOL in amputees seems primarily determined by mobility impairment, pain, emotional perturbation, it is seen that physician-controlled factors such as the timing of amputation, informed decision making, and postamputation support may also play an important role. This data can be efficiently collected through limb deficiency and phantom limb questionnaire. During the rehabilitation process, multiple tools are available that help physicians to determine both motor ability and mobility in amputees as well as other determinants of quality of life and pain status of amputees. These include tests that determine motor ability as Single-limb standing balance test (Balance test), the Lower-Extremity Motor Coordination Test (LEMOCOT) and the Amputee Mobility Predictor without a prosthesis (AMPnoPRO). The AMP is a highly reliable instrument and it is relatively easy to administer in 15 minutes or less. Patients characteristics can be easily evaluated using "Limb Deficiency and Phantom Limb Questionnaire (Questionnaire 2008, Version 2)" and visual analogue scale (VAS) for the presence and extent of PLP. Health-related quality of life (HRQL) will be measured by the SF-36 questionnaire.
Despite a growing body of evidence, phantom limb pain remains a challenging condition to treat. There remains a large potential for innovation in improving the treatment strategies for these patients. More than 25 treatments for PLP are currently available yet not one is widely accepted or superior to others. Common self-treatment strategies can include wearing an elastic stump sock to minimise volume changes in the residual limb, stump massage, mental imagery of the phantom limb and taking physical exercise.
A rehabilitation technique that proved promising in recent years is mirror therapy, which involves a mirror being placed in a position that allows the patient to view a reflection of a body part. whilst the nonpainful limb is placed in front of the mirror so that it creates a reflection that can be seen by the patient, the stump is kept behind the mirror. In amputees, this creates the illusion of having two intact limbs and then the patient is asked to move an intact limb in certain patterns. This gives the illusion that the painful limb can move normally too. The mechanism of action of mirror therapy remains uncertain, with the reintegration of motor and sensory systems, restored body image and control over fear-avoidance likely to influence the outcome. Nevertheless, mirror therapy is inexpensive, safe and easy for the patient to self-administer but the level of evidence is insufficient. A limitation of the mirror box technique is the poor verisimilitude of the sensory feedback provided from the missing limb. The participant may have the visual illusion that the phantom extremity is moving, but the apparatus is crude and the illusion often not compelling. Patients cannot independently control the mirrored extremity, so only symmetric actions can be modelled.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral lower limb amputation
- •Phantom limb pain score (40-100 on VAS)
- •Either gender
- •Stable prosthetic situation (i.e. satisfaction with the fitting of the prosthesis) or being a non-user.
排除标准
- •Amputees with psychological/neurological impairments.
- •Amputees having neuropathic pain other than phantom limb pain.
- •Patients having visual-spatial impairments.
- •Taking pain relief medications will also be excluded.
- •Patients having residual limb pain.
- •Inability to give informed consent.
- •Carcinoma
- •Infectious stump
- •Severe hearing loss
- •Any condition that restricts the movement of opposite limb, pain or limited range of motion in the intact limb
- •Infectious and systematic diseases
结局指标
主要结局
Visual analogue scale (VAS)
时间窗: 4 weeks
changes from the baseline, The visual analogue scale The VAS evaluates pain subjectively. It consists of a 100-mm line, with two endpoints representing "no pain" to "worst pain imaginable from left to right." Patients are instructed to mark on the line according to the level of pain and the same is measured
Limb Deficiency and Phantom Limb Questionnaire
时间窗: day 1
Patients will be evaluated using "Limb Deficiency and Phantom Limb Questionnaire (Questionnaire 2008, Version 2)" in order to assess their eligibility for including in this study. this questionnaire does not have any scoring, it only concludes the questions on Yes/No basis for presence or absence of phantom limb pain.
Amputee Mobility predictor
时间窗: 4 weeks
changes from the baseline, Amputee mobility predictor (AMP) is an amputee-specific tool for predicting ambulatory potential. This clinical test evaluates the predicted mobility of amputee with and without a prosthesis The AMP is a clinical test consisting of 20 tasks that are given a score of 0, 1, or 2 based on the amputee's performance. There is an item 21 where a score is given ranging from 0 to 5.
次要结局
- Short form 36 (SF-36)(4 weeks)
