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Somatosensory Assessment and Rehabilitation of Allodynia (SARA)

Somatosensory Assessment and Rehabilitation of Allodynia: the SARA Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02070367
Acronym
SARA
Enrollment
39
Registered
2014-02-25
Start date
2014-10-31
Completion date
2017-06-30
Last updated
2017-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndrome, Hand Fractures, Peripheral Nerve Injuries

Keywords

allodynia, complex regional pain syndrome, peripheral nerve injuries, clinical measurement properties

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.

Interventions

OTHERSomatosensory rehabilitation
OTHERUsual treatment: physiotherapy

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Hamilton Health Sciences Corporation
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
McGill Pain Questionnairebaseline to 6 month follow-uptotal number and intensity of sensory and affective pain descriptors selected by participant

Secondary

MeasureTime frameDescription
Pain subscale of the Patient-Rated Wrist and Hand EvaluationBaseline to six months5 questions rating self-reported pain at rest, with movement, pain with lifting, worst pain and pain frequency.
Hamilton Inventory for Complex Regional Pain SyndromeBaseline to 6 monthsIncludes 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 versionBaseline to 6 monthsself-reported evaluation of sensitivity in an area of injury/trauma

Other

MeasureTime frameDescription
Goniometric measurement of active range of motion (ROM) of the upper extremitiesBaseline to 3 monthsMeasures 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).
Pain Catastrophizing ScaleBaseline to 6 monthsMeasures pain-related beliefs
Dynamometry for grip and pinch strengthBaseline to 3 monthsbilateral measures of hand grip and pinch strength
AllodynographyBaseline to 3 monthsa graphical technique to anatomically map allodynia associated with a specific nerve branch and assess the area and associated pressure threshold
10 testBaseline to 3 monthsquick form of quantitative sensory testing for light touch sensation and hypersensitivity
Infra-red skin temperature measurement asymmetryBaseline and 3 monthsInfra-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).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026