Somatosensory Assessment and Rehabilitation of Allodynia (SARA) (SARA)
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|ClinicalTrials.gov Identifier: NCT02070367|
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : August 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Complex Regional Pain Syndrome Peripheral Nerve Injuries Hand Fractures||Other: Somatosensory rehabilitation Other: Usual treatment: physiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Somatosensory Assessment and Rehabilitation of Allodynia: the SARA Pilot Study|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||June 2017|
Experimental: 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.
Other: Somatosensory rehabilitation
Other: Usual treatment: physiotherapy
Active Comparator: Usual treatment
Treatment as usual for condition Physiotherapy sessions
Other: Usual treatment: physiotherapy
- McGill Pain Questionnaire [ Time Frame: baseline to 6 month follow-up ]total number and intensity of sensory and affective pain descriptors selected by participant
- Pain subscale of the Patient-Rated Wrist and Hand Evaluation [ Time Frame: Baseline to six months ]5 questions rating self-reported pain at rest, with movement, pain with lifting, worst pain and pain frequency.
- Hamilton Inventory for Complex Regional Pain Syndrome [ Time Frame: 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 [ Time Frame: Baseline to 6 months ]self-reported evaluation of sensitivity in an area of injury/trauma
- 10 test [ Time Frame: Baseline to 3 months ]quick form of quantitative sensory testing for light touch sensation and hypersensitivity
- Pain Catastrophizing Scale [ Time Frame: Baseline to 6 months ]Measures pain-related beliefs
- Allodynography [ Time Frame: Baseline to 3 months ]a graphical technique to anatomically map allodynia associated with a specific nerve branch and assess the area and associated pressure threshold
- Infra-red skin temperature measurement asymmetry [ Time Frame: Baseline and 3 months ]Infra-red measures of skin temperature are taken over 3 specific areas (corresponding to the most distal autonomous innervation from the 3 major peripheral nerves of the upper limb) and symmetry is compared between the right and left arms. This measurement procedure is then repeated after a 30 second immersion of the right foot in ice water (5 degrees C).
- Goniometric measurement of active range of motion (ROM) of the upper extremities [ Time Frame: Baseline to 3 months ]Measures of affected and unaffected limbs (shoulder flexion and abduction, elbow flexion/extension, wrist flexion/extension, forearm pronation/supination, active functional ROM of the fingers, thumb opposition).
- Dynamometry for grip and pinch strength [ Time Frame: Baseline to 3 months ]bilateral measures of hand grip and pinch strength
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070367
|Hamilton Health Science, General Site|
|Hamilton, Ontario, Canada, L9G 3L1|
|Principal Investigator:||Joy C MacDermid, PhD||School of Rehabilitation Sciences, McMaster University|