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Clinical Trials/NCT02070367
NCT02070367
Completed
Not Applicable

Somatosensory Assessment and Rehabilitation of Allodynia: the SARA Pilot Study

Hamilton Health Sciences Corporation1 site in 1 country39 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complex Regional Pain Syndrome
Sponsor
Hamilton Health Sciences Corporation
Enrollment
39
Locations
1
Primary Endpoint
McGill Pain Questionnaire
Status
Completed
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
June 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (1)

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