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Complex Regional Pain SyndromesNCT06587750

Cognitive Multisensory Rehabilitation for CRPS Treatment

A study testing Cognitive Multisensory Rehabilitation in people with Complex Regional Pain Syndromes, run by Royal United Hospitals Bath NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 (i.e. perceiving the exact location of a touch on the painful hand with eyes closed). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Complex Regional Pain Syndromes
What is being tested?
Cognitive Multisensory Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited Kingdom
Study dates
1 Feb 2023to 1 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Royal United Hospital

    Bath, BA1 3NG

Other trials in United Kingdom

About this study

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

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.

Read the 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 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).

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.

Being tested
Cognitive Multisensory Rehabilitation
Keywords
Complex Regional Pain Syndrome, CRPS, Occupational Therapy, Physiotherapy, Physical Therapy
Medical subject headings
Complex Regional Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Multisensory RehabilitationBehavioural

    Also called CMR

    CMR targets somatosensory and multisensory and cognitive functions through sensory discrimination exercises.

Study groups in NCT06587750
Study groupRoleWhat they receive
CMR interventionExperimentalParticipants receive CMR intervention delivered by a treatment partner in a home enviornment
Receives: Behavioral: Cognitive Multisensory Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Pre-post intervention (4 weeks)

  2. 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

    Measured: Pre-post intervention (4 weeks)

Secondary outcomes (7)
  1. Neuropathic Pain Symptom Inventory (ranging from 0-100, higher score indicates worse outcome)

    Pain

    Measured: Pre-post intervention (4 weeks)

  2. Tampa Scale of Kinesiophobia (ranging from 17-68, higher score indicates worse outcome)

    Kinesiophobia

    Measured: Pre-post intervention (4 weeks)

  3. The Bath CRPS body perception disturbance scale (ranging from 0-57, higher score indicate worse outcome)

    Body perception disturbance of painful limb

    Measured: Pre post intervention (4 weeks)

  4. Evaluation of Daily Activity Questionnaire (ranging from 0-147, higher scores indicate worse outcome)

    Physical function

    Measured: Pre post intervention (4 weeks)

  5. EQ-5D-5L (0-100, higher value indicates better outcome)

    Quality of life

    Measured: Pre post intervention (4 weeks)

  6. Tactile acuity (higher value indicates worse outcome)

    Two point discrimination threshold at the pulp of the index finger or hallux

    Measured: Pre post intervention (4 weeks)

  7. Numerical Rating Scale (0-10, higher outcome indicates worse outcome)

    Pain

    Measured: Pre post intervention (4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Feb 2023
  3. Primary completion1 Nov 2024
  4. Study completion1 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Feasibility study
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06587750
Sponsor's protocol ID
CharFund Jan2022 MPB
Status last verified
Sep 2024
First submitted
13 Aug 2024
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Multisensory Rehabilitation in people with Complex Regional Pain Syndromes, run by Royal United Hospitals Bath NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Pre-post intervention (4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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