Testing a device to improve sensation in a painful limb

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 15

Inclusion Criteria

1. Adults (aged 18+ years) meeting the Budapest clinical criteria for upper or lower limb CRPS Type I
2. An area on their limb where a wearable band with electrode array can be attached above their painful site
3. An average pain level in the last 7 days rated as =5 at rest on a 0-10 scale
4. Access to appropriate technology and willingness to use this technology, that enables full study participation (a smart phone, tablet computer or computer compatible with using the video call function on Microsoft Teams, internet access, camera and an email address, physical and mental capacity to tolerate use of technology)
5. A person within their household, carer or a friend to carry out the two-point discrimination measurement

Exclusion Criteria

1. Diagnosis of any other neurological, motor disorder or major nerve damage (including CRPS Type II)
2. Any mental health condition which may detrimentally impede on study participation, in the judgement of the patient or researcher
3. The presence of any other limb pathology or pain on the affected CRPS limb
4. Poor skin condition on the area to be stimulated
5. Poorly controlled epilepsy
6. Receiving intensive CRPS specific multidisciplinary team rehabilitation in an inpatient setting during the time course of the study or within the previous month
7. Unable to understand written or verbal English and give informed consent
8. Active medical implants such as cardiac pacemakers or other devices
9. Exposed orthopaedic metalwork in the area of electrical stimulation
10. Pregnancy
11. Those living alone who have not formed a ‘support bubble’ with another household (applies only if social distancing measures, as recommended by the government, are still in place, as there would be no-one able to take the two-point discrimination measurement)
12. Known allergy to acrylates (added 20/07/2021)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
se of the STS device and adherence to the treatment plan, recorded by the STS device during the 30-day usage

Secondary Outcome Measures

Name	Time	Method
Measured before and after 30 days of use of the STS device: <br>1. Average pain intensity over the past 7 days assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) Numeric Rating Scale (v.1.0 -Pain Intensity 1a)<br>2. Pain interference over the past 7 days assessed using an 11-point numerical rating scale (0-10). This comprises four items in the PROMIS Item Bank (v1.1 – Pain Interference – Short Form 4a).<br>3. Average sensitivity over the past 7 days assessed on an 11-point numerical rating scale (0-10)<br>4. Participant's emotional feeling about their affected limb assessed on an 11-point numerical rating scale (0-10), informed by the Bath CRPS Body Perception Disturbance Scale