An interventional study of Cognitive Multisensory Rehabilitation in Complex Regional Pain Syndromes, sponsored by Royal United Hospitals Bath NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Royal United Hospitals Bath NHS Foundation Trust · Not applicable, Interventional, and Treatment
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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.
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:
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).
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 (e.g. somatosensory, visual, etc.) and body parts (e.g. 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 (e.g. 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 (i.e. body perception disturbances, loss of self-ownership and amputation desire, allodynia and motor impairments). In CMR, patients are guided to increase their affected limb's 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: e.g. the patient has to recognise different types of stimuli on the painful limb, such as which fabric they feel (i.e. 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.
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 54 are open to participants now.
This study's enrollment of 4 is below the median of 40 across 152 interventional studies indexed under Complex Regional Pain Syndromes.
Browse Complex Regional Pain Syndromes studies →Royal United Hospitals Bath NHS Foundation Trust is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive CMR intervention delivered by a treatment partner in a home enviornment
Behavioral: Cognitive Multisensory Rehabilitation
CMR targets somatosensory and multisensory and cognitive functions through sensory discrimination exercises.
Also known as: CMR
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).
Suitability
Time frame: Pre-post intervention (4 weeks)
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).
Feasibility
Time frame: Pre-post intervention (4 weeks)
Neuropathic Pain Symptom Inventory (ranging from 0-100, higher score indicates worse outcome)
Pain
Time frame: Pre-post intervention (4 weeks)
Tampa Scale of Kinesiophobia (ranging from 17-68, higher score indicates worse outcome)
Kinesiophobia
Time frame: Pre-post intervention (4 weeks)
The Bath CRPS body perception disturbance scale (ranging from 0-57, higher score indicate worse outcome)
Body perception disturbance of painful limb
Time frame: Pre post intervention (4 weeks)
Evaluation of Daily Activity Questionnaire (ranging from 0-147, higher scores indicate worse outcome)
Physical function
Time frame: Pre post intervention (4 weeks)
EQ-5D-5L (0-100, higher value indicates better outcome)
Quality of life
Time frame: Pre post intervention (4 weeks)
Tactile acuity (higher value indicates worse outcome)
Two point discrimination threshold at the pulp of the index finger or hallux
Time frame: Pre post intervention (4 weeks)
Numerical Rating Scale (0-10, higher outcome indicates worse outcome)
Pain
Time frame: Pre post intervention (4 weeks)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Feb 2023 to primary completion in Nov 2024, 21 months.
Of 64 non-industry interventional studies with no phase under Complex Regional Pain Syndromes, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's 21 months is below that.
Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 14 and three quarters within 60.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Complex Regional Pain Syndromes →
Royal United Hospitals Bath NHS Foundation Trust