Cognitive Multisensory Rehabilitation for CRPS Treatment

NCT06587750 | Completed

• 1 other identifier: CharFund Jan2022 MPB
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Complex Regional Pain Syndromes

Keywords

Complex Regional Pain Syndrome; CRPS; Occupational Therapy; Physiotherapy; Physical Therapy

Outcome Measures

Primary Outcomes (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).

  Suitability

  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

  Pre-post intervention (4 weeks)

Secondary Outcomes (7)

• 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)

• 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)

Study Arms (1)

CMR intervention

EXPERIMENTAL

Participants receive CMR intervention delivered by a treatment partner in a home enviornment

Behavioral: Cognitive Multisensory Rehabilitation

Interventions

Cognitive Multisensory Rehabilitation BEHAVIORAL

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

Also known as: CMR

CMR intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead

Study Sites (1)

Royal United Hospital

Bath, BA1 3NG, United Kingdom

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Jane Carter, Head

  Royal United Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: September 19, 2024
• Study Start: February 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-09

Locations

GB (1)