Somatosensory Assessment and Rehabilitation of Allodynia (SARA) (SARA)

August 8, 2017 updated by: Hamilton Health Sciences Corporation

Somatosensory Assessment and Rehabilitation of Allodynia: the SARA Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L9G 3L1
        • Hamilton Health Science, General Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
McGill Pain Questionnaire
Time Frame: baseline to 6 month follow-up
total number and intensity of sensory and affective pain descriptors selected by participant
baseline to 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to six months
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
Baseline to 6 months
Radboud Evaluation of Sensitivity- English version
Time Frame: Baseline to 6 months
self-reported evaluation of sensitivity in an area of injury/trauma
Baseline to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 test
Time Frame: Baseline to 3 months
quick form of quantitative sensory testing for light touch sensation and hypersensitivity
Baseline to 3 months
Pain Catastrophizing Scale
Time Frame: Baseline to 6 months
Measures pain-related beliefs
Baseline to 6 months
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
Baseline to 3 months
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).
Baseline and 3 months
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).
Baseline to 3 months
Dynamometry for grip and pinch strength
Time Frame: Baseline to 3 months
bilateral measures of hand grip and pinch strength
Baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Joy C MacDermid, PhD, School of Rehabilitation Sciences, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 21, 2014

First Posted (Estimate)

February 25, 2014

Study Record Updates

Last Update Posted (Actual)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-798

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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