Somatosensory Assessment and Rehabilitation of Allodynia (SARA)

N/ACompletedNCT02070367

Hamilton Health Sciences Corporation39 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Complex Regional Pain Syndrome

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

McGill Pain Questionnaire

total number and intensity of sensory and affective pain descriptors selected by participant

Time frame: baseline to 6 month follow-up

Secondary Outcomes

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.

Time frame: 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

Time frame: Baseline to 6 months

Radboud Evaluation of Sensitivity- English version

self-reported evaluation of sensitivity in an area of injury/trauma