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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

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.


Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome Peripheral Nerve Injuries Hand Fractures Other: Somatosensory rehabilitation Other: Usual treatment: physiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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

  3. Radboud Evaluation of Sensitivity- English version [ Time Frame: Baseline to 6 months ]
    self-reported evaluation of sensitivity in an area of injury/trauma


Other Outcome Measures:
  1. 10 test [ Time Frame: Baseline to 3 months ]
    quick form of quantitative sensory testing for light touch sensation and hypersensitivity

  2. Pain Catastrophizing Scale [ Time Frame: Baseline to 6 months ]
    Measures pain-related beliefs

  3. 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

  4. 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).

  5. 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).

  6. Dynamometry for grip and pinch strength [ Time Frame: Baseline to 3 months ]
    bilateral measures of hand grip and pinch strength



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Hamilton Health Science, General Site
Hamilton, Ontario, Canada, L9G 3L1
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Joy C MacDermid, PhD School of Rehabilitation Sciences, McMaster University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02070367     History of Changes
Other Study ID Numbers: 13-798
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017

Keywords provided by Hamilton Health Sciences Corporation:
allodynia
complex regional pain syndrome
peripheral nerve injuries
clinical measurement properties

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Peripheral Nerve Injuries
Hyperalgesia
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Trauma, Nervous System
Wounds and Injuries
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms