Somatosensory Assessment and Rehabilitation of Allodynia: the SARA Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 39
- Locations
- 2
- Primary Endpoint
- McGill Pain Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Usual treatment: physiotherapy (Other)
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.
Intervention: Somatosensory rehabilitation (Other)
Usual treatment
Treatment as usual for condition Physiotherapy sessions
Intervention: Usual treatment: physiotherapy (Other)
Outcomes
Primary Outcomes
McGill Pain Questionnaire
Time Frame: baseline to 6 month follow-up
total number and intensity of sensory and affective pain descriptors selected by participant
Secondary Outcomes
- Hamilton Inventory for Complex Regional Pain Syndrome(Baseline to 6 months)
- Radboud Evaluation of Sensitivity- English version(Baseline to 6 months)
- Pain subscale of the Patient-Rated Wrist and Hand Evaluation(Baseline to six months)