Somatosensory Assessment and Rehabilitation of Allodynia (SARA)

Study Overview
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Brief Summary
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This pilot study will test a new therapy, somatosensory rehabilitation, for the painful sensitivity experienced by persons with nerve injuries and/or complex regional pain syndrome (CRPS). Several methods for measuring pain and sensitivity that emphasize the person's evaluation of their own symptoms and the impact of these symptoms on their daily activities will also be tested to make sure they are consistent and accurate. Previous research has suggested one of the assessments may also be used to assist in the identification of CRPS: this simple test will be evaluated to see if it can accurately identify persons with this disorder (for which there is currently no diagnostic test). Together, this will improve treatment of CRPS through early, accurate diagnosis and the ability to measure important changes in this painful condition, and set up future studies for this new rehabilitation treatment method.

Detailed Description
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We will test four groups: persons with CRPS of one upper extremity, persons with recent hand fractures (<12 weeks) or peripheral nerve injuries with residual sensory deficits at the time of the study, and healthy normal volunteers with a battery of assessments for CRPS, including a technique to precisely localize and quantify static mechanical allodynia.

Official Title
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Somatosensory Assessment and Rehabilitation of Allodynia: the SARA Pilot Study

Conditions
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Complex Regional Pain Syndrome, Peripheral Nerve Injuries, Hand Fractures

Intervention / Treatment
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* Other: Somatosensory rehabilitation
* Other: Usual treatment: physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of a) Complex Regional Pain Syndrome or b) Peripheral Nerve Injury or c) recent hand trauma without peripheral nerve injury in a single upper extremity confirmed by physician or medical record. Participant and most responsible physician give consent to exclusive focus on somatosensory rehabilitation for the duration of the trial (6 months). The participant may continue any oral medications but any planned use of topical medication, injections or IV medication in the affected limb is contra-indicated. Use of these modalities in an emergency situation would of course take priority. Exclusion Criteria: History of cardiac or vascular disease or known sensitivity to sympathetic stress or cold intolerance or medically unstable Confounding diagnoses: whiplash, nerve root compression, metabolic diseases such as diabetes or thyroid problems, and/or peripheral neuropathy Open wounds on testing sites Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somatosensory rehabilitation<br>Weekly sessions with a certified (RSDC) somatosensory therapist using distal vibro-tactile counter-stimulation to anatomically related territories of the area of allodynia. Participants will also be provided with a structured home exercise program. | Other: Somatosensory rehabilitation<br> <br> Other: Usual treatment: physiotherapy<br> <br> |
| Active Comparator: Usual treatment<br>Treatment as usual for condition Physiotherapy sessions | Other: Usual treatment: physiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| McGill Pain Questionnaire | total number and intensity of sensory and affective pain descriptors selected by participant | baseline to 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain subscale of the Patient-Rated Wrist and Hand Evaluation | 5 questions rating self-reported pain at rest, with movement, pain with lifting, worst pain and pain frequency. | Baseline to six months | 
| Hamilton Inventory for Complex Regional Pain Syndrome | Includes a both a patient-reported scale addressing symptoms, daily function and psychosocial concerns; and a clinician-based assessment of clinical signs | Baseline to 6 months | 
| Radboud Evaluation of Sensitivity- English version | self-reported evaluation of sensitivity in an area of injury/trauma | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allodynia, complex regional pain syndrome, peripheral nerve injuries, clinical measurement properties