Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587750
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Cognitive Multisensory Rehabilitation for CRPS Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cognitive Multisensory Rehabilitation a Novel Sensorimotor Intervention for Pain Reduction in Complex Regional Pain Syndrome a Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie 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 eg 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 eg 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
Detailed Description:
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 orand 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 individuals 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 limbs 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 andor having the affected limb set in a sustained fixed posture ie dystonia
Sensorimotor interventions ie interventions aiming to improve sensory and motor feedback of the affected limb have shown promising outcomes on increasing perception associated with the affected limb ie 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 ie body perception disturbances loss of self-ownership and amputation desire and motor impairments
Cognitive Multisensory Rehabilitation is a term agreed by the International Cognitive Multisensory Rehabilitation Centre to describe a sensorimotor intervention originally developed for stroke motor rehabilitation by Professor Perfetti 1940-2020 CMR targets somatosensory and multisensory and cognitive functions through sensory discrimination exercises It focuses on the perception and integration of different sensory modalities eg somatosensory visual etc and body parts eg shoulder and hand in order to produce purposeful effective and accurate movements allowing an appropriate relationship with the surrounding environment Clinical observations from the CRPS service at the Royal United Hospital RUH have suggested that CMR may have an impact on symptom reduction eg decreased body perception disturbances or pain reduction as a part of a multidisciplinary rehabilitation programme
In contrast to other sensorimotor interventions CMR offers a comprehensive range of sensorimotor tasks targeting a wider range of sensorimotor cognitive and body representation impaired functions in CRPS ie body perception disturbances loss of self-ownership and amputation desire allodynia and motor impairments In CMR patients are guided to increase their affected limbs perception by discriminating different sensory information through the activation of cognitive processes such as perception attention or body representation and mindful movements
Furthermore unlike sensorimotor interventions CMR tasks are considered to be discrimination-based eg the patient has to recognise different types of stimuli on the painful limb such as which fabric they feel ie tactile discrimination Because of this CMR interventions require a trained facilitator whose role is to help the patients to recognise the different sensory information with eyes closed by physically guiding the patient as well as posing the cognitive question Preliminary data has shown that improvements in pain levels observed following sensorimotor interventions were enhanced and lasted longer if people with CRPS discriminated between different stimuli as opposed to just receiving sensory stimulation on the painful body part This suggested that a broader activation of cognitive processes such as problem solving attention and perception may increase the effectiveness of sensorimotor interventions
Recently Covid-19 restrictions have prompted the increase of home-based treatment complementing therapy treatment Home-based discrimination sensory retraining has shown promising results in pain reduction for people with CRPS
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 orand 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 individuals 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 limbs 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 andor having the affected limb set in a sustained fixed posture ie dystonia
Sensorimotor interventions ie interventions aiming to improve sensory and motor feedback of the affected limb have shown promising outcomes on increasing perception associated with the affected limb ie 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 ie body perception disturbances loss of self-ownership and amputation desire and motor impairments
Cognitive Multisensory Rehabilitation is a term agreed by the International Cognitive Multisensory Rehabilitation Centre to describe a sensorimotor intervention originally developed for stroke motor rehabilitation by Professor Perfetti 1940-2020 CMR targets somatosensory and multisensory and cognitive functions through sensory discrimination exercises It focuses on the perception and integration of different sensory modalities eg somatosensory visual etc and body parts eg shoulder and hand in order to produce purposeful effective and accurate movements allowing an appropriate relationship with the surrounding environment Clinical observations from the CRPS service at the Royal United Hospital RUH have suggested that CMR may have an impact on symptom reduction eg decreased body perception disturbances or pain reduction as a part of a multidisciplinary rehabilitation programme
In contrast to other sensorimotor interventions CMR offers a comprehensive range of sensorimotor tasks targeting a wider range of sensorimotor cognitive and body representation impaired functions in CRPS ie body perception disturbances loss of self-ownership and amputation desire allodynia and motor impairments In CMR patients are guided to increase their affected limbs perception by discriminating different sensory information through the activation of cognitive processes such as perception attention or body representation and mindful movements
Furthermore unlike sensorimotor interventions CMR tasks are considered to be discrimination-based eg the patient has to recognise different types of stimuli on the painful limb such as which fabric they feel ie tactile discrimination Because of this CMR interventions require a trained facilitator whose role is to help the patients to recognise the different sensory information with eyes closed by physically guiding the patient as well as posing the cognitive question Preliminary data has shown that improvements in pain levels observed following sensorimotor interventions were enhanced and lasted longer if people with CRPS discriminated between different stimuli as opposed to just receiving sensory stimulation on the painful body part This suggested that a broader activation of cognitive processes such as problem solving attention and perception may increase the effectiveness of sensorimotor interventions
Recently Covid-19 restrictions have prompted the increase of home-based treatment complementing therapy treatment Home-based discrimination sensory retraining has shown promising results in pain reduction for people with CRPS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None