Somatosensory Assessment and Rehabilitation of Allodynia (SARA)
- Conditions
- Complex Regional Pain SyndromePeripheral Nerve InjuriesHand Fractures
- Interventions
- Other: Somatosensory rehabilitation
- Registration Number
- NCT02070367
- Lead Sponsor
- Hamilton Health Sciences Corporation
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Somatosensory rehabilitation Somatosensory rehabilitation 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.
- Primary Outcome Measures
Name Time Method McGill Pain Questionnaire baseline to 6 month follow-up total number and intensity of sensory and affective pain descriptors selected by participant
- Secondary Outcome Measures
Name Time Method Hamilton Inventory for Complex Regional Pain Syndrome Baseline to 6 months Includes a both a patient-reported scale addressing symptoms, daily function and psychosocial concerns; and a clinician-based assessment of clinical signs
Radboud Evaluation of Sensitivity- English version Baseline to 6 months self-reported evaluation of sensitivity in an area of injury/trauma
Pain subscale of the Patient-Rated Wrist and Hand Evaluation Baseline to six months 5 questions rating self-reported pain at rest, with movement, pain with lifting, worst pain and pain frequency.
Trial Locations
- Locations (1)
Hamilton Health Science, General Site
🇨🇦Hamilton, Ontario, Canada