Cognitive Multisensory Rehabilitation, a Novel Sensorimotor Intervention for Pain Reduction in Complex Regional Pain Syndrome: a Feasibility Study
Phase: NA
Conditions: Complex Regional Pain Syndromes
Sponsor: Royal United Hospitals Bath NHS Foundation Trust

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COGNITIVE MULTISENSORY REHABILITATION, A NOVEL SENSORIMOTOR 
INTERVENTION FOR SYMPTOM REDUCTION IN COMPLEX REGIONAL PAIN 
SYNDROME: A FEASIBILITY STUDY 
Marc Aureli Pique Batalla1, Janet Bultitude2 Marco Rigoni3 and Jennifer 
Lewis1,4 
 
1 The Royal National Hospital for Rheumatic Diseases; 2 University of Bath; 3 
Cognitive Multisensory Rehabilitation Centre and 4 University of West of England.  
 
Introduction 
This protocol describes a study aimed to investigate the feasibility and 
appropriateness of a novel sensorimotor treatment approach called Cognitive 
Multisensory Rehabilitation (CMR1-3) 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, 
respectively4. 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)5. Motor problems 
include troubles in initiating movement, weakness and reduced function amongst 
others6.  

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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 
normal7.  
• 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)6. 
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 touch8) and decreasing pain intensity9,10,11. 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 CRPS9,12. 
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)13. 
Cognitive Multisensory Rehabilitation14-19 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 exercises1-3. 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. 

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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 (See figure 1).  
 
 
Figure 1: Cognitive Multisensory Rehabilitation components 
 
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 

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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 data10 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 CRPS11.  
Overarching hypothesis 
Is CMR a treatment that can be adapted to treat CRPS patients in a home-based 
environment by a trained treatment partner?  
Research questions to be answered  
1. Is CMR a suitable, feasible, efficient and safe treatment intervention to treat 
people with CRPS in a home-based environment by a trained treatment 
partner? 
Aims of the study 
1. To identify relevant information regarding the delivery of CMR in CRPS 
patients in a home-based environment by a trained treatment partner, in terms 
of: 
a. Suitability: to determine if the intervention is appropriate for CRPS 
patients.  
b. Feasibility: to determine the degree to which the intervention can be 
easily and safely delivered by a trained treatment partner and received 
by a CRPS patient. 
Design 
A feasibility study design will be used to address the aims of this research. 

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Study population 
CRPS patients who access the CRPS Service at the Royal United Hospital in Bath 
and their treatment partner (i.e. participants’ relative or friend). 
Study sample 
A total sample of ten participants will be recruited for the study: five people with 
CRPS who access the CRPS Service at the Royal United Hospital and their 
treatment-partner (i.e. participants’ husband, wife, friend, etc.). This sample is 
considered sufficient for this type of study to obtain enough data to meet the 
identified aims of this study.  
Description of study population 
Recruitment selection criteria  
1) CRPS patients from the CRPS Service at the Royal United Hospital. 
Inclusion criteria: 
• 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 someone available to act as treatment facilitator and consent to participate in the study. 
 
Exclusion criteria: 
• 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. 
2) Treatment partner 

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Inclusion criteria: 
• 18 years in age or older. 
• Able to understand verbal and written English. 
• Willing to participate and provide written informed consent. 
• Able to commit to delivering the treatment with the patient regularly within the 
home environment. 
 
Exclusion criteria: 
• Serious ill health. 
• Inability to deliver the treatment due to time, physical, mental or other 
constraints. 
 
3. Research procedures 
3.1 Recruitment including informed consent 
a) CRPS potential participants will be recruited via the following ways: 
i. In the initial assessment at the CRPS Service in the RUH by the clinical 
multi-disciplinary team. Potential recruits will be approached by a 
member of the CRPS multidisciplinary team (independent from the 
research lead) during the initial assessment. If they are interested in 
participating, a recruitment pack will be handed to them.  
ii. In a planned admission of patients to the CRPS residential programme. 
Prior to the admission in the CRPS residential programme, the CRPS 
administration team will send out the recruitment pack to all CRPS 
patients.  
The recruitment pack will contain an invitation letter, participant information sheet, 
reply slip and freepost envelope. Alternatively, these documents can be provided 
electronically (i.e. by email). The recruitment pack will contain the contact details for 
the lead investigator.   
In order to ensure those CRPS patients that have already been approached and not 
responded at the initial assessment are not then approached for the second time if 
booked on the programme, CRPS administration will keep a log of packs handed 

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(see appendix 4).  Some patient planned admission are CRPS patients returning to 
the CRPS inpatient program and therefore do not go through the initial assessment 
route. 
b) Treatment partner will be identified by the CRPS patients among friends and 
relatives. Once CRPS potential participants will have shown interest in participating 
in the study, they will be asked to provide us with the contact details of a potentially 
interested friend or relative. A separate recruitment pack containing will be sent to 
them with an invitation letter, participant information sheet, reply slip and freepost 
envelope and/or will provide these documents electronically (i.e. by email). 
Expressions of interest in study 
Having read the participant information sheet, if the CRPS potential participant is 
interested in the study and identifies a potential treatment partner, they will contact 
MPB via face-to-face/phone/reply slip or email. MPB then will contact the potential 
CRPS patient and treatment partner. Both CRPS patients and treatment-partner will 
have the opportunity to discuss any remaining queries/concerns as well as explore 
practical and technical issues regarding their participation in the study (e.g. total 
amount of practice during the intervention period, the frequency of the session and 
the time for the intervention to be delivered). MPB will confirm that they meet the 
eligibility criteria for the study.  
Eligibility, screening and consent  
CRPS participants and treatment partner that meet the eligibility criteria will be given 
a consent form (either in a physical document or in electronic format, (see form in 
appendix 3).  
Once CRPS patients and treatment partner have given informed consent to take part 
in the study, they will agree with MPB on the date and time for all the sessions 
(Session 1, Intervention phase and Session 2) and make an appointment date for 
Session 1. Four copies of the signed consent form for CRPS patients and treatment 
partner will be made, one for the CRPS patient another for the treatment partner (to 
keep), one filed in the medical notes (if they are a patient at the CRPS Service) and 
digitally scanned and the other kept in the research site file on a password protected 
digital folder. 
3.3 Methods  

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The outline of study sessions is presented in figure 2:  
Session 1: Pre-intervention clinical assessment and Intervention Training 
Session 1 will take place in a confidential clinic room at the RUH and will comprise 
two parts: pre-intervention clinical assessments and intervention training for 
treatment partner.  
• Baseline clinical assessment (Outcome measures) 
CRPS participants will be asked to fill in patient-reported outcome measures 
(PROMS) as follows: 
Pain (Neuropathic Pain Symptom Inventory20 and Numerical Rating Scale21); Pain 
interference (Neuropathic Pain Symptom Inventory20); 
Neuropathic Pain Symptom Inventory20: The Neuropathic Pain Symptom Inventory 
(NPSI) is one of the most widely used tools for characterizing neuropathic pain 
symptom severity. The NPSI is comprised of five subscales, each representing 
different dimensions of neuropathic pain: burning spontaneous pain (burning), 
pressing spontaneous pain (pressing), paroxysmal pain (paroxysmal), evoked pain 
(evoked), and paraesthesia/dysesthesia. Moreover, the NPSI has good construct 
validity, high test–retest reliability, and good sensitivity to change in people with 
peripherally mediated neuropathic pain. 
Numerical Rating Scale21: The Numerical Rating Scale (NPRS-11) is an 11-point 
scale for self-report of pain. It is the most commonly used unidimensional pain scale. 
The respondent selects a whole number (integers 0–10) that best reflects the 
 
 
Figure 2: Outline of study sessions. 

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intensity (or other quality if requested of his/her pain. The anchors are 0 = no pain 
and 10 = extreme pain/worst possible pain (there are various different wordings of 
the upper anchor). It is often categorised into: no pain = 0, mild pain= 1-3, moderate 
pain = 4-6, severe pain = 7-10. Moreover NPRS has shown to be highly correlated 
with the Visual Analogue Scale (VAS), ranging from 0.86 to 0.95 and has a high test-
retest reliability (r = 0.95)22 
Chronic Pain Acceptance Questionnaire (CPAQ-revised)23. The 20-item CPAQ-
revised has been designed to measure acceptance of pain. The acceptance of 
chronic pain is thought to reduce unsuccessful attempts to avoid or control pain and 
thus focus on engaging in valued activities and pursuing meaningful goals. There 
have been 2 factors identified in the CPAQ-Revised: (1) Activity engagement (pursuit 
of life activities (2) Pain willingness (recognition that avoidance and control are often 
unworkable methods of adapting to chronic pain). The items on the CPAQ are rated 
on a 7-point scale from 0 (never true) to 6 (always true). To score the CPAQ, items 
for Activity engagement and Pain willingness to obtain a score for each factor. To 
obtain the total score, add the scores for each factor together. Higher scores indicate 
higher levels of acceptance. CPAQ-revised has shown very good to excellent 
internal consistency with alphas of .82 (Activity engagement) and .78 (Pain 
willingness) and moderate to high correlations with measures of avoidance, distress, 
and daily functioning. 
 
Kinesiophobia  
Tampa Scale of Kinesiophobia24: The Tampa Scale for Kinesiophobia (TSK) is a 17 
item questionnaire used to assess the subjective rating of kinesiophobia or fear of 
movement. The TSK is a self-completed questionnaire and the range of scores are 
from 17 to 68 where the higher scores indicate an increasing degree of 
kinesiophobia. The questionnaire using 4 points to assess that are based on; the 
model of fear-avoidance, fear of work-related activities, fear of movement, and fear 
of re-injury25. Several studies have found the scale to be a valid and reliable 
psychometric measure26. 
Body perception disturbance of painful limb: 
The Bath CRPS body perception disturbance scale is used to measure changes in 
body perception of the affected limb7. Values of 0.66 for Cronbach’s alpha and 0.87 

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for Cohen’s kappa suggest adequate internal consistency27,28 and adequate 
interrater 
reliability29 
of 
the 
scale. 
In order to obtain the nature and extent of these perceptual disturbances the 
questionnaire comprises seven items covering different aspects related to the 
affected limb. These are: (1) a sense of ownership; (2) limb position awareness; (3) 
attention paid to the limb; (4) emotional feelings towards the limb; (5) perceptual 
disparities in size, temperature, pressure and weight (compared to the unaffected 
limb); (6) a desire to amputate the limb; and (7) a mental representation of the 
affected 
limb. 
Five of these seven items are rated on a 0 to 10 scale to establish the extent of 
abnormality within that item. The sixth item determines the subjective perception of 
changes in size, weight pressure and temperature. The final item illustrates the 
mental 
representation 
of 
both 
the 
affected 
and 
unaffected 
limbs. 
The final item involves an illustration of the mental representation of both the 
affected and unaffected limb. With eyes closed the participant generates a mental 
picture of both upper limbs commencing with their unaffected side. As the participant 
verbalises their mental image the assessor draws a picture of both limbs based on 
these descriptions. The resultant drawing is assessed by the participant for accuracy 
and truthfulness and adjusted as necessary by the experimenter following the 
participant’s instructions. The drawing is independently graded by the experimented 
on a three-point scale: no distortion=0, distortion=1, severe distortion=2. If either a 
distortion in size or shape is depicted within the drawing, or the accompanying 
textual descriptions, i.e. that it is not anatomically consistent with the actual size or 
shape of the limb, the rating ‘distortion’ is given by the experimenter. A rating of 
‘severe distortion’ is given if one or more segments of the limb are missing. The total 
score is calculated by summing the individual scores of the seven items7. The higher 
the score the greater is the degree of disturbance. Estimated completion time is 5 
minutes. Patients’ body perception disturbances will be assessed using this tool 
twice in total – once at the beginning of session 2 and once at the end of session 3. 
Physical function PROMIS-29 v2.0 profile30  
Evaluation of Daily Activity Questionnaire31: The Evaluation of Daily Activity 
Questionnaire (EDAQ) is a self-report assessment. It evaluates, in detail, a person’s 
daily activity abilities with and without using ergonomic solutions (i.e. using alternate 

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movements and positions, activity simplification, pacing, planning, assistive devices, 
gadgets and equipment) or help. It includes numeric rating scales evaluating impact 
of conditions on e.g. pain, fatigue, mood and also 138 activities within 14 domains 
(sub-scales). This include: Eating /Drinking, In the Bathroom/ Personal Care, Getting 
Dressed/ Undressed, Bathing/ Showering, Cooking, Moving Around Indoors, 
Cleaning 
the 
House, 
Laundry 
/ 
Clothes 
Care, 
Moving 
and 
Transfers, 
Communication, Moving Around Outside/ Shopping, Gardening/ Household 
Maintenance, Caring and Hobbies, Leisure and Social Activities. The EDAQ was 
originally developed and partially tested in the mid-1990’s with women with 
rheumatoid arthritis in Sweden32,33 and translated into English by Beaton et al, 2000. 
It has been psychometrically tested several conditions including chronic pain34. 
PROMIS-29 v2.0 profile30: The PROMIS-29 v2.0 profile measure assesses pain 
intensity using a single 0–10 numeric rating item and seven health domains (physical 
function, fatigue, pain interference, depressive symptoms, anxiety, ability to 
participate in social roles and activities, and sleep disturbance) using four items for 
each domain. PROMIS-29 has an excellent test-retest validity (≥0.80)26 
 
EQ-5D-5L36: The descriptive system comprises five dimensions: mobility, self-care, 
usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 
levels: no problems, slight problems, moderate problems, severe problems and 
extreme problems. The patient is asked to indicate his/her health state by ticking the 
box next to the most appropriate statement in each of the five dimensions. This 
decision results in a 1-digit number that expresses the level selected for that 
dimension. The digits for the five dimensions can be combined into a 5-digit number 
that describes the patient’s health state. The EQ VAS records the patient’s self-rated 
health on a vertical visual analogue scale, where the endpoints are labelled ‘The 
best health you can imagine’ and ‘The worst health you can imagine’. The VAS can 
be used as a quantitative measure of health outcome that reflect the patient’s own 
judgement. EQ-5D-5L exhibits excellent psychometric properties across a broad 
range of populations, conditions and settings37. 
Furthermore, CRPS participants will undergo a clinical test to measure their tactile 
acuity, the two-point discrimination threshold (2PD38), which will be assessed at the 

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pulp of the index finger or hallux (depending on the CRPS location, taking 
approximately 5 minutes) to all CRPS patients included.  
Two point discrimination threshold at the pulp of the index finger or hallux: As 
a measure of tactile acuity, a two point discrimination test will be undertaken on the 
distal pulp of the index fingers (IF) of both the affected and unaffected hands (both 
IFs in HVs) according to Moberg’s method (1990)38. This test assesses the smallest 
distance at which an individual can clearly distinguish between two points applied 
simultaneously to the skin. With the participant’s eyes closed, the aesthesiometer 
(Homecraft Rolyan, Nottingham, UK) is applied to the surface with the smallest 
possible distance between the two points until the skin blanches. The participant 
reports whether they feel the touch of one or two points. The distance between the 
two points is gradually increased for each trial until the participant correctly discerns 
two rather than one point. Three consecutive correct answers at the smallest 
discernable distance determine the two-point discrimination threshold (2ptDT). We 
will perform three 2ptDT assessments over the course of the intervention (i.e. at 
baseline, half way through the intervention, and immediately after the intervention). 
Sham trials involving stimulation of one point only will be pseudo-randomly included, 
with a total of 1-4 sham trials per 2ptDT assessment. Three threshold measurement 
trials will be taken on the index finger of each hand during each 2ptDT assessment. 
The mean of these trials will be calculated for each IF. The estimated completion 
time for each 2ptDT assessment is 5 minutes. Patients’ two-point discrimination will 
be assessed using this tool twice in total – once at the beginning of session 2 and 
once at the end of session 3. 
• Training for treatment partner:  in additional to the outcome measures, MPB will 
individually clinically assess each CRPS patient participant including but not 
limited to: 
o Pain assessment: Pain intensity, pain location, pain triggers, pain 
beliefs/attitudes, presence of sensory symptoms (such as allodynia and/or 
hypersensitivity). 
o Posture (standing / sitting, postural shift). 

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o Functional 
strategies 
(including 
posture, 
transfers 
and 
ADLs): 
Inability/struggle to perform certain tasks involving the painful limb (e.g. 
gait or reach-to-grasp). 
o Current mobility / falls history / risk of falls. 
o Movement (range, strength, quality, weakness, motor dysfunction). 
o Significant Dysfunction (e.g. BPD, allodynia, hypersensitivity, dystonia, 
hypervigilance, inattention, relationship with affected body part (e.g. 
attention, feelings, associations, perception, representation, amputation 
desire) 
o Secondary Issues (e.g. non-CRPS symptoms, incontinence). 
Based on each clinical presentation, MPB will produce an individualized CMR 
treatment for each CRPS participant: This treatment plan will consist on 2-5 CMR 
tasks that the treatment partner will deliver to CRPS participant during the 
intervention phase. A hard copy of every task will be handed to the treatment partner 
(an example can be found in the Appendix section 1). For every single CMR tasks 
the follow information will be given: 
• Task number. 
• Task name. 
• Task description. 
• Material required (e.g. different fabrics). 
• Patient position. 
• Modality includes a step-by-step procedure to deliver the task. 
• Number of repetitions: 
• Photos: 
As a part of session 1, treatment partner will observe and learn the treatment plan 
under the supervision of MPB (i.e. practising the exercises with MPB’s guidance). 
The training session will end when treatment partner will be competent enough to 
deliver the intervention to good quality standards (will be assessed using the CMR 
tasks structure; cognitive problem (treatment partner is able to ask the question that 

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prompts the sensory discrimination - perceptual hypothesis (the CRPS participants is 
aware of which sensory information they have to focus on (e.g. tactile or 
proprioception) and verification (the treatment partner prompts the CRPS 
participants to check if they answer correctly). In case the treatment partner does not 
gain enough competency to deliver the intervention, further training will be offered 
from the lead investigator. A short questionnaire will be used to assess 
understanding and competency regarding the study intervention. Treatment partner 
will receive a hard copy with written guidance of the CMR tasks to be delivered 
including delivery instructions (an example can be found in the Appendix section 1). 
There will be opportunities for both the CRPS patient and treatment partner to ask 
questions regarding CMR. The overall goal of this session is to prepare both CRPS 
patients and treatments partner to engage with the CMR treatment.  
The anticipated total duration of session 2 is up to 3 hours with a rest break within 
the session. 
Intervention phase: 
The CMR home-intervention involves the recommended treatment plan being 
delivered by the treatment partner over a four-week period.  The CRPS patient and 
treatment partner can refer to the written guidance provided for the different 
recommended tasks (an example can be found in the Appendix section 1). As part of 
a feasibility study the CRPS-patient and treatment partner would have agreed with 
MPB about the duration and frequency of the intervention sessions and this will be 
recorded in the written treatment plan. MPB will encourage treatment partner to 
deliver the intervention daily. A rehabilitation diary will be provided to record 
frequency and duration of treatment sessions and any other comments (see 
Appendix 2 for an example).  
Weekly Zoom meetings will be agreed between the CRPS-participant, treatment 
partner, MPB and Marco Rigoni (Cognitive Multisensory Rehabilitation Centre, Italy) 
in order to evaluate progress on the intervention and modify treatment plan if 
required (e.g. increasing the complexity of the tasks or adding new CMR tasks). 
Marco Rigoni who will supervise the CMR treatment during the weekly zoom calls, 
providing further specialist CMR knowledge. 
Session 2: Post-intervention clinical assessments 

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Following the four-week home-delivered intervention, CRPS patients and treatment 
partner will be invited to undergo the post-intervention clinical assessment session at 
the RUH in Bath. Post-intervention clinical assessments includes a repeat data 
collection of the self-reported measures completed at session 1 (see section Session 
1).   
Furthermore, CRPS-patients and treatment partner will be invited to attend an 
interview by MPB in order to gain insight in their experience of delivering/receiving 
CMR. The interview questions will be devised in order to gain insights on adherence, 
efficiency, acceptability, and safety of the intervention. This interview will include the 
discussion of: 
• Content, 
• Goals, 
• Duration, 
• Frequency and 
• Modality of delivery of CMR 
The anticipated total duration of session 1 is up to 1 hour. 
3.4 Analysis 
Planned analyses specific to each study aim: 
1. 
To identify the suitability, feasibility of delivering CMR in people with 
CRPS. In order to answer the overarching research question the total number of 
sessions, their duration and frequency will be described as well as the presence of 
any exacerbation of symptoms during the intervention will be recorded rehabilitation 
diary, which will be handed to the lead investigator during session 2.  
Furthermore, descriptive comments regarding both delivering and receiving the 
intervention will be collected on the interview sessions, goals, duration, frequency 
and modality of delivery of CMR. The diary will be analysed in order to gain insight 
on the adherence, efficiency, acceptability, and safety of the intervention. 
2. 
To determine the feasibility of running an appropriately powered 
efficacy study on the effectiveness of CMR in CRPS. In order to gain some 

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preliminary insights into the potential effectiveness of the intervention, we will inspect 
for each person the change in scores on each outcome measure, relative to clinically 
meaningful differences. Pre- and Post-intervention clinical assessments data will be 
described and summarized, and their distribution will be ascertained using IBM 
SPSS Statistics (SPSS Inc, Chicago USA).  
4. Research procedure risks and benefits 
4.1 Anticipated risks 
The potential risk for our patient participants is a temporary exacerbation of 
pain/discomfort, or nausea/dizziness related to the altered perception of their 
affected limb. These temporary changes should all settle within 24 hours after testing 
or the intervention. In the unlikely event that these effects persist for more than 48 
hours, the participant will be advised to consult with their GP.  
Procedures for recording incidents or adverse events 
In the unlikely event that the participant experiences an adverse or unanticipated 
effect, they will be encouraged to contact the principal investigator (MPB) by phone 
or email who will provide advice. All symptoms and adverse events reported will be 
collected by the researchers and added to the participants’ files. Both adverse 
effects related to the study (i.e. they resulted from the intervention administration or 
of any of the research procedures) and unexpected (i.e. not listed in the protocol as 
an expected occurrence) will be emailed to the research ethics committee (REC) 
within three days.  
4.2 Anticipated benefits 
We anticipate that there might be benefits in participating in the study. These include 
improvements in pain, limb spatial awareness, tactile acuity, body perception 
disturbances and physical function. Furthermore, we hope that by evaluating the 
feasibility of this intervention, we can develop future non-invasive treatment 
alternatives that can target CRPS-related signs and symptoms.  
5. Ethical and legal considerations 
5.1 Ethics 

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Prior to the commencement of this research study an application and the study 
protocol will be submitted to a Research Ethics Committee (NRES) through the 
Integrated Research Application System (IRAS) with the South West Committee. 
All patients will continue to receive their routine care as appropriate and any 
voluntary involvement in this study will be in addition to that care. Participants will be 
informed that their participation is voluntary and that they can terminate the study at 
any time if they wish to do so without any consequences for their routine care. 
Research data security, management and storage  
The study will comply with the GDPR rules and the Data Protection Act. The term 
research data in this protocol refers to all forms including and not restricted to video 
recordings, paper and digital data. 
Paper consent forms signed to indicate the voluntary participation in the research 
study will be stored securely only at the Royal United Hospital in Bath. Personally 
identifiable data (such as contact details, subjects’ name, NHS number or date of 
birth) and data collected from the study will be anonymized and allocate unique 
identifier and then kept within a digital data file, securely stored on a password 
protected and encrypted shared drive at the RUH in Bath; this shared drive can be 
remotely accessed from secure computers at the University of West of England and 
Bath by Jenny Lewis. The research team may look at the participants’ medical 
history subjects’ suitability for the study. 
Once the study is completed and the personally identifiable data are no longer 
needed the file containing personally identifiable data will be deleted according to the 
RUH guidelines. 
If the participant stop being part of a research study at any time, the research team 
will keep the research data about you that they already have.  
Encoded descriptive and psychometric participant data will be imported and 
analysed using data analysis software, e.g. SPSS. These electronic files will be 
stored within the encrypted study network at the RUH, which is accessible only via 
password protected computers, and on a password protected and encrypted shared 
drive at UWE and UoB; the last two can be remotely accessed from secure 
computers at the UoB by Janet Bultitude and by Dr Jenny Lewis at UWE. 
Data management plan 

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While only MPB will have access to personally identifiable data, all named 
researchers will have access to the data once anonymised and encoded. The 
responsibilities of the data management and its analysis are listed in the following 
table (see table). Please note that Janet Bultitude will assist in the analysis. 
Data archiving 
As per NHS Research Ethics Committees, paper and digital data will be stored at 
Royal United Hospital and kept 5 years. 
Complaints 
If a participant complains about how researchers have handled your information, 
they will need to contact the research lead, MPB. If they do not receive a satisfactory 
response, they will be pointed to contact the Data Protection Officer.  
Information Commissioner’s Office (ICO) (www.ico.org.uk  or 0303 123 1113). 
Data management plan 
While only MPB will have access to personally identifiable data, all named 
researchers will have access to the data once anonymised and encoded. The 
responsibilities of the data management and its analysis are listed in the following 
table.  

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Table 1 Data management plan 
 
Marc Aureli Pique 
Batalla 
Jenny Lewis 
Janet Bultitude 
Marco Rigoni 
Obtaining study consent 
and storing consent forms 
 
 
 
 
Collecting and storing 
demographic and 
psychometric data  
 
 
 
 
 
Encoding data (allocating 
participant code) 
 
 
 
 
Baseline clinical 
assessment and treatment 
prescription 
 
 
 
 
Follow up CMR treatment 
 
 
 
 
Collecting data post-
intervention 
 
 
 
 
Transferring data to 
statistic program, e.g. 
SPSS 
 
 
 
 
Data interpretation 
 
 
 
 
Discussion of the data for 
publication/dissemination 
 
 
 
 
Write manuscript for 
publication in peer-
reviewed journal 
 
 
 
 
Agree on final manuscript 
draft before submission 
 
 
 
 
 
6. Participant expenses 
All reasonable participant travel and parking costs to attend research visits to Bath 
will be reimbursed. Funding has been secured from Royal National Hospital for 
Rheumatic Diseases Donated Research Funds. 
7. Publication and dissemination. 
Findings from this study will be written up for publication in appropriate peer-
reviewed academic journals. No patient identifiable data will be used. Furthermore, 
these findings will be disseminated both in written and oral forms at relevant national 
and international conferences.  
8. Scientific and statistical review 
The proposed study has been scientifically peer reviewed as part of the Royal 
National Hospital for Rheumatic Diseases Donated Research Funds award process. 

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Statistical analysis will be conducted using IBM SPSS Statistics 23 (SPSS Inc, 
Chicago USA) and will be supervised by Janet Bultitude (University of Bath). 
9. Research sites and investigators 
Research data collection will be undertaken at RUH in Bath by MPB (session 1 and 
2). Treatment will be determined by MPB and supervised by MPB and Marco Rigoni 
(Cognitive Multisensory Rehabilitation Centre, Italy). Data analysis will be 
undertaken at RUH in Bath. 
10. Research costs 
Award funding from a Royal National Hospital for Rheumatic Diseases Donated 
Research Funds grant covers the research costs for this study.  
11. Proposed time frame 
Month 
0-2: Ethics 
2-4: Identification of potential participants and recruitment 
6-10: Data collection 
10-12: Data analysis and dissemination 

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Appendix 1: Example of CMR task sheet for treatment partner 
 
Task number: 
1 
Task name: 
Spatial discrimination and comparison between affected and unaffected arms. 
Task 
description 
In this exercise the therapist positions the patient’s unaffected hand in a grid 
position and asks the patient to position her affected hand in the same 
positioning the opposite grid to ‘mirror’ the unaffected hand.  
Material 
required 
A table, and table grid (optional) 
Patient 
position 
Comfortable sitting position in a chair both arms resting in a table. 
 
Modality 
Patient with eyes closed.  
Therapist to move patients’ unaffected arm into a position.  
Patient prompted to match (i.e. to mirror) the position with affected arm paying 
attention to the position on the arm rather than pain.  
Encouraged patient to verify by opening eyes.  
Number of 
repetitions  
 
___ repetitions 
Photos  
 
 

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Appendix 2: Example of rehabilitation diary for the home-based intervention 
 
Please insert date and total duration of the session:  
Task number: 
 
Able to complete? 
Yes 
No, provide the reason: 
 
Total time task (in 
minutes) and number of 
repetitions 
___min. 
__repetitions 
Patient was able to 
answer correctly 
Yes, always 
Yes, often 
Yes, sometimes 
Not at all 
Any adverse effects 
(including symptom flare) 
Yes, please 
describe 
 
 
No 
 
Task number: 
 
Able to complete? 
Yes 
No, provide the reason: 
 
Total time task (in 
minutes) and number of 
repetitions 
___min. 
__repetitions 
Patient was able to 
answer correctly 
Yes, always 
Yes, often 
Yes, sometimes 
Not at all 
Any adverse effects 
(including symptom flare) 
Yes, please 
describe 
 
 
No 
 

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Appendix 3: Participant consent form 
PARTICIPANT CONSENT FORM A: CRPS PATIENT 
 
COGNITIVE MULTISENSORY REHABILITATION, A NOVEL SENSORIMOTOR INTERVENTION 
FOR PAIN REDUCTION IN COMPLEX REGIONAL PAIN SYNDROME: A FEASIBILITY 
STUDY 
 
Name of researcher: Marc Aureli Pique Batalla  
 
1. I confirm that I have read and understood the information sheet dated [20/07/2023, V5]  
for the above study. I have had the opportunity to consider the information, ask questions 
and have had these answered satisfactorily. There will be 3 copies of this document:  
x1 copy for participant, x1 copy for medical records and x1 copy for investigator's site file. 
 
2. I understand my participation is voluntary and that I am free to withdraw at any time, without 
giving any reason, and without my medical care and legal rights being affected.  
I understand that data collected prior to my withdrawal will be used in the study. 
 
3. I understand that researchers from the Royal United Hospital (RUH; Marc Aureli Pique Batalla 
and Jenny Lewis), University of the West of England (UWE; Jenny Lewis), University of Bath 
(UoB; Janet Bultitude) and Cognitive Multisensory Rehabilitation Centre (Marco Rigoni)  
that are part of this study may examine and analyse data collected during the study. I give 
permission for these individuals to have access to this anonymised data. 
 
4. I understand that all information and data collected from me, as part of the project  
will be securely retained by RUH for 5 years in line with NHS National record management 
guidelines.   
 
 
5. I consent to be audio recorded.  
 
 
 
6. I confirm that my data, which will be anonymized, can be used for future undescribed  
analyses by researchers who may, but are not necessarily members of the named team of 
researchers responsible for the current study 
 
7. I understand that relevant sections of my medical notes and data collected during the study,  
may be looked at by individuals from University of the West of England  
(UWE; Jenny Lewis), University of Bath (UoB; Janet Bultitude) and  
Cognitive Multisensory Rehabilitation Centre (Marco Rigoni),  
from regulatory authorities or from the NHS Trust, where it is relevant  
to my taking part in this research. I give permission for these individuals  
to have access to my records 
 
8. I agree to take part in the above study. 
 
 
Please initial 
either the  
YES or NO box 
YES 
NO 
YES 
NO 
YES 
NO 
YES 
NO 
YES 
NO 
NO 
YES 
YES 
NO 
YES 
NO 
YES 
NO 

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Data protection 
 
The Royal United Hospital (RUH) will process your data in accordance with the General Data 
Protection Regulation as applied, enacted and amended in UK law. Your data will only be processed 
with your consent for the purposes described above and will only be shared outside of Royal United 
Hospital (including overseas with appropriate safeguards) in the circumstances described above. 
 
Your rights 
In respect of your personal data held by us, you have the following qualified rights to: 
- 
access it 
- 
receive it in a structured machine readable format 
- 
rectify it if it is not accurate or complete 
- 
erase it  
- 
restrict its processing 
- 
withdraw any consent provided or otherwise object to its processing 
- 
complain to the Information Commissioner’s Office (ICO) 
 
To find out more or to exercise any of these rights please contact the Data Protection Officer via e-
mail: dpo@ico.org.uk 
 
   
 
 
………………………………………………………………………………….. 
Name of patient                             Date                              Signature   
                          …………………………………………………………………………………… 
Name of person taking consent     Date                              Signature 
(If different from researcher)                                            
 
 
 ……………………………..……………………………………………………. 
Name of researcher                       Date                              Signature   

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Appendix 4: Recruitment packaged log 
 
CRPS 
patient’s 
name 
 
Attended CRPS 
Initial 
Assessment (Y/N)  
If yes, please 
insert the date 
Interested in 
participating? 
(Y/N) 
Handed 
recruitment 
pack (Y?N) 
If yes, 
please 
insert the 
date 
 
Attending 
CRPS 
rehabilitation 
program 
(Y/N)?  If yes, 
please insert 
the date 
Interested in 
participating? 
(Y/N) 
Sent 
recruitment 
pack (Y/N) 
If yes, 
please 
insert the 
date