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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
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

Tracking Information
First Submitted Date  ICMJE February 3, 2014
First Posted Date  ICMJE February 25, 2014
Last Update Posted Date August 9, 2017
Study Start Date  ICMJE October 2014
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2014)
McGill Pain Questionnaire [ Time Frame: baseline to 6 month follow-up ]
total number and intensity of sensory and affective pain descriptors selected by participant
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02070367 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 21, 2014)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Somatosensory Assessment and Rehabilitation of Allodynia (SARA)
Official Title  ICMJE Somatosensory Assessment and Rehabilitation of Allodynia: the SARA Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Complex Regional Pain Syndrome
  • Peripheral Nerve Injuries
  • Hand Fractures
Intervention  ICMJE
  • Other: Somatosensory rehabilitation
  • Other: Usual treatment: physiotherapy
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Somatosensory rehabilitation
    • Other: Usual treatment: physiotherapy
  • Active Comparator: Usual treatment
    Treatment as usual for condition Physiotherapy sessions
    Intervention: Other: Usual treatment: physiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2017)
39
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2014)
120
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02070367
Other Study ID Numbers  ICMJE 13-798
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hamilton Health Sciences Corporation
Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Joy C MacDermid, PhD School of Rehabilitation Sciences, McMaster University
PRS Account Hamilton Health Sciences Corporation
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP