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临床试验/NCT06587750
NCT06587750已完成不适用

Cognitive Multisensory Rehabilitation, a Novel Sensorimotor Intervention for Pain Reduction in Complex Regional Pain Syndrome: a Feasibility Study

Royal United Hospitals Bath NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Number of sessions (number of total sessions), duration (total duration of intervention in minutes), frequency (number of sessions over 4 weeks), presence of any exacerbation of symptoms (number total of symptom exacerbation).

研究概览

简要总结

Pain treatment for Complex Regional Pain Syndrome (CRPS) is challenging. There is some evidence that pain can be reduced by therapies aimed at helping patients 'find' normal sensation in the painful body part (i.e. perceiving the exact location of a touch on the painful hand with eyes closed). In this study, a collaboration between the CRPS service at Royal United Hospital (RUH), University of the West of England (UWE), University of Bath (UoB) and Cognitive Multisensory Rehabilitation Center, the investigators aim to test whether it is possible to administer a treatment called Cognitive Multisensory Rehabilitation (CMR) to people with CRPS. In order to do this, treatment-partners (e.g. spouses, partners) will be trained to deliver CMR in a home-based environment under the supervision of a CMR specialist. Generally speaking, CMR is a rehabilitation technique in which patients are guided to better feel their painful limb by paying more attention to different sensations (e.g. touch, or position), and mindfully moving it. Since previously CMR has shown promising results in people with stroke, the investigators believe that this method could be very useful for treating pain in CRPS.

详细描述

Introduction This protocol describes a study aimed to investigate the feasibility and appropriateness of a novel sensorimotor treatment approach called Cognitive Multisensory Rehabilitation (CMR) for symptom reduction in people living with Complex Regional Pain Syndrome (CRPS). This study has been informed by the findings of a CRPS-patient focus group as well as clinical observations at the Royal United Hospital in Bath. The findings from this feasibility study will inform the design of larger studies to investigate the effectiveness of CMR in CRPS, offering a novel, non-drug related treatment to CRPS treatment.

Background CRPS is a chronic pain condition of unknown aetiology that commonly occurs following trauma to a limb, although it may occur spontaneously. It is defined as type 1 or type 2, depending on whether known major nerve damage is absent or present, respectively. Patients with Complex Regional Pain Syndrome commonly describe a diverse range of sensory and motor abnormalities. Sensory problems include pain to touch or the threat of touch, evoked pain, pain hypersensitivity (allodynia or/and hyperalgesia; pain due to a stimulus that does not normally provoke pain and an increased sensitivity to feeling pain and an extreme response to pain, respectively), but at the same time non-noxious sensory loss (hypoesthesia). Motor problems include troubles in initiating movement, weakness and reduced function amongst others.

Clinical features often present in people living with CRPS commonly resulting in patients having difficulty to engage with their affected limb and therefore having a detrimental effect on rehabilitation outcomes are:

  • Body perception disturbances: the reported individual's perceived alteration of their CRPS affected body part while regarding the remainder of their body as normal.
  • Loss of self-ownership and amputation desire: patients' perception that the painful limb(s) do not belong to them and the desire to amputate these body parts.
  • Allodynia: painful response to a stimulus that does not normally produce pain.
  • Motor impairments: including tremor, decreased range of movement, muscle weakness, and/or having the affected limb set in a sustained, fixed posture (i.e. dystonia).

Sensorimotor interventions (i.e. interventions aiming to improve sensory and motor feedback of the affected limb) have shown promising outcomes on increasing perception associated with the affected limb (i.e. tactile acuity; precision with which we can sense touch) and decreasing pain intensity. Although its mechanisms are largely unknown, it is thought that the 'normalized' sensory and motor feedback may compete with pain stimulus resulting in pain reduction in people with CRPS. The evidence for the effectiveness of these treatment modalities in CRPS is weak, and often focus only on pain reduction. Thus further research is required on novel sensorimotor interventions that target also other abnormalities present in CRPS (i.e. body perception disturbances, loss of self-ownership and amputation desire and motor impairments).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants meet the Budapest criteria for Type I CRPS4 (i.e. the diagnostic criteria for CRPS) in one limb (unilateral).
  • Pain duration for a minimum of 3 months.
  • 18 years in age or older.
  • Able to understand verbal and written English.
  • Willing to participate and provide written informed consent.
  • Have not previously received CMR.
  • Have someone available to act as treatment facilitator and consent to participate in the study.

排除标准

  • Presence of any co-morbidity that may influence CRPS symptoms including stroke, diabetic peripheral neuropathy, progressive neurological disease such as multiple sclerosis, and Parkinson's disease.
  • Presence of Post-Traumatic Stress Disorder or other psychological conditions hindering patients' ability to engage with the intervention.
  • Serious ill health.

结局指标

主要结局

Number of sessions (number of total sessions), duration (total duration of intervention in minutes), frequency (number of sessions over 4 weeks), presence of any exacerbation of symptoms (number total of symptom exacerbation).

时间窗: Pre-post intervention (4 weeks)

Suitability

次要结局

  • Neuropathic Pain Symptom Inventory (ranging from 0-100, higher score indicates worse outcome)(Pre-post intervention (4 weeks))
  • Tampa Scale of Kinesiophobia (ranging from 17-68, higher score indicates worse outcome)(Pre-post intervention (4 weeks))
  • The Bath CRPS body perception disturbance scale (ranging from 0-57, higher score indicate worse outcome)(Pre post intervention (4 weeks))
  • Tactile acuity (higher value indicates worse outcome)(Pre post intervention (4 weeks))
  • Evaluation of Daily Activity Questionnaire (ranging from 0-147, higher scores indicate worse outcome)(Pre post intervention (4 weeks))
  • EQ-5D-5L (0-100, higher value indicates better outcome)(Pre post intervention (4 weeks))
  • Numerical Rating Scale (0-10, higher outcome indicates worse outcome)(Pre post intervention (4 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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