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NCT Number: NCT02070367

Somatosensory Assessment and Rehabilitation of Allodynia (SARA)

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.

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Key information

Conditions

Complex Regional Pain Syndrome Autonomic Nervous System Diseases Complex Regional Pain Syndromes Hand Fractures Hyperalgesia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nerve Injuries Peripheral Nervous System Diseases Sensation Disorders Signs and Symptoms Somatosensory Disorders Trauma, Nervous System Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Science, General Site

Hamilton, Ontario, L9G 3L1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatosensory rehabilitation

Other

Usual treatment: physiotherapy

Other

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Somatosensory Assessment and Rehabilitation of Allodynia: the SARA Pilot Study

Acronym: SARA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2014
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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