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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatosensory rehabilitation | Experimental | 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. |
|
| Usual treatment | Active Comparator | Treatment as usual for condition Physiotherapy sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatosensory rehabilitation | Other |
| ||
| Usual treatment: physiotherapy |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 10 test | quick form of quantitative sensory testing for light touch sensation and hypersensitivity | Baseline to 3 months |
| Pain Catastrophizing Scale | Measures pain-related beliefs |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joy C MacDermid, PhD | School of Rehabilitation Sciences, McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Science, General Site | Hamilton | Ontario | L9G 3L1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22975739 | Background | Packham TL, Fok D, Frederiksen K, Thabane L, Buckley N. Reliability of infrared thermometric measurements of skin temperature in the hand. J Hand Ther. 2012 Oct-Dec;25(4):358-61; quiz 362. doi: 10.1016/j.jht.2012.06.003. Epub 2012 Sep 10. | |
| 22265445 | Background | Packham T, MacDermid JC, Henry J, Bain JR. The Hamilton Inventory for Complex Regional Pain Syndrome: a cognitive debriefing study of the clinician-based component. J Hand Ther. 2012 Jan-Mar;25(1):97-111; quiz 112. doi: 10.1016/j.jht.2011.09.007. |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D059348 | Peripheral Nerve Injuries |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| Other |
|
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 |
| Baseline to 6 months |
| Allodynography | a graphical technique to anatomically map allodynia associated with a specific nerve branch and assess the area and associated pressure threshold | Baseline to 3 months |
| Infra-red skin temperature measurement asymmetry | 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). | Baseline and 3 months |
| Goniometric measurement of active range of motion (ROM) of the upper extremities | 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). | Baseline to 3 months |
| Dynamometry for grip and pinch strength | bilateral measures of hand grip and pinch strength | Baseline to 3 months |
| 35005383 | Derived | Packham T, MacDermid J, Bain J, Buckley N. Identification of complex regional pain syndrome in the upper limb: Skin temperature asymmetry after cold pressor test. Can J Pain. 2018 Aug 21;2(1):248-257. doi: 10.1080/24740527.2018.1504283. eCollection 2018. |
| 31858880 | Derived | Packham TL, Spicher CJ, MacDermid JC, Quintal I, Buckley N. Evaluating a sensitive issue: reliability of a clinical evaluation for allodynia severity. Somatosens Mot Res. 2020 Mar;37(1):22-27. doi: 10.1080/08990220.2019.1704242. Epub 2019 Dec 20. |
| 30908579 | Derived | Packham TL, Spicher CJ, MacDermid JC, Buckley ND. Allodynography: Reliability of a New Procedure for Objective Clinical Examination of Static Mechanical Allodynia. Pain Med. 2020 Jan 1;21(1):101-108. doi: 10.1093/pm/pnz045. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |