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Treatment of complex regional pain syndrome (CRPS) with sensory-motor adaptation

Pain Reduction by Inducing Sensory-Motor Adaptation in Complex Regional Pain Syndrome (CRPS): a double-blind randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46828292
Enrollment
63
Registered
2017-03-27
Start date
2017-03-31
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndrome (CRPS) Signs and Symptoms Complex Regional Pain Syndrome (CRPS)

Interventions

Eligible patients will be allocated to 1 of 2 treatment groups: sensory-motor adaptation treatment group or control treatment group, by method of randomization with stratification to minimize baseline

Sponsors

University of Bath
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy volunteers: 1. Willing and able to give informed consent for participation in the study 2. Aged 18-80 3. Healthy and without current pain Patients: 1. Willing and able to give informed consent for participation in the study 2. Aged 18-80 3. Diagnosed with CRPS type I of minimum three months chronicity, primarily affecting one upper limb, based on Budapest research criteria that will be assessed on the first research visit 4. Reporting current pain intensity =2 on a 0-10 Numeric Rating Scale on the first and second research visit (as of 05/10/2018)

Exclusion criteria

Exclusion criteria: All participants: 1. A history of neurological disorder (e.g. a stroke, neurodegenerative disease, traumatic brain injury) 2. Classified as legally blind 3. Lacking sufficient English language ability to provide informed consent Patients: 1. CRPS affecting both sides of the body, or confirmed presence of nerve damage 2. Dystonia or any other physical limitation that is severe enough to prevent movement of the affected limb Decisions whether or not to exclude a participant suffering from a psychiatric disorder will be made on a case-by-case basis, as patients with CRPS often present with co-morbid depression and anxiety.

Design outcomes

Primary

MeasureTime frame
1. Current self-reported pain intensity measured using item 6 of the Brief Pain Inventory (short form) at weeks 4 (immediately before the commencement of the treatment period) and 7 (immediately after the end of the treatment period) 2. CRPS diagnosis and symptoms severity measured using Budapest research criteria at weeks 4 and 7

Secondary

MeasureTime frame
Pain: 1. Current self-reported pain intensity in weeks 1, 11, 19 and 31 2. Worst and least pain over the last 24 hours measured using items 3 and 4 of the Brief Pain Inventory (short form) at weeks 1, 4, 7, 11, 19 and 31 3. Neuropathic component of pain measured using Pain Detect Questionnaire at weeks 1, 4, 7, 11, 19 and 31 Physical/clinical signs: 1. CRPS diagnosis and symptoms severity measured using Budapest research criteria at weeks 1, 11, 19 and 31 2. Mechanical detection and pain thresholds and dynamic mechanical allodynia measured using selected tests from Quantitative Sensory Testing (QST) at weeks 1, 4, 7 and 11 3. Tactile discrimination threshold measured using Two-Point Discrimination test (2PD) at weeks 1, 4, 7 and 11 4. Limb temperature asymmetry (unaffected-minus-affected hand) measured using infrared thermometer at weeks 1, 4 ,7 and 11 Limb perception: 1. Presence, nature and extent of body perception disturbance measured using Bath CRPS Body Perception Disturbance scale (BPD) at weeks 1, 4, 7, 11, 19 and 31 2. Body representation disturbance measured using Hand Laterality Recognition task at weeks 1, 4, 7 and 11 Attention to the affected limb and surrounding space: 1. Visual spatial attention measured using Landmark task, Greyscales task and Temporal Order Judgement task (TOJ) at weeks 1, 4, 7 and 11 2. Motor spatial performance measured using Directional Hypokinesia task at weeks 1, 4, 7 and 11 3. Mental representation of space measured using Mental Number Bisection task at weeks 1, 4, 7 and 11 The following measures will also be recorded to check that the groups are matched on extraneous factors that are thought to influence pain, attention, and treatment effects (these measures may also be

Countries

England, United Kingdom

Contacts

Public ContactMonika Halicka

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026