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

Primary Purpose

Complex Regional Pain Syndrome, Peripheral Nerve Injuries, Hand Fractures

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Somatosensory rehabilitation
Usual treatment: physiotherapy
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome focused on measuring allodynia, complex regional pain syndrome, peripheral nerve injuries, clinical measurement properties

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hamilton Health Science, General Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Somatosensory rehabilitation

Usual treatment

Arm Description

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.

Treatment as usual for condition Physiotherapy sessions

Outcomes

Primary Outcome Measures

McGill Pain Questionnaire
total number and intensity of sensory and affective pain descriptors selected by participant

Secondary Outcome Measures

Pain subscale of the Patient-Rated Wrist and Hand Evaluation
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
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
self-reported evaluation of sensitivity in an area of injury/trauma

Full Information

First Posted
February 3, 2014
Last Updated
August 8, 2017
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02070367
Brief Title
Somatosensory Assessment and Rehabilitation of Allodynia (SARA)
Acronym
SARA
Official Title
Somatosensory Assessment and Rehabilitation of Allodynia: the SARA Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome, Peripheral Nerve Injuries, Hand Fractures
Keywords
allodynia, complex regional pain syndrome, peripheral nerve injuries, clinical measurement properties

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Somatosensory rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual treatment
Arm Type
Active Comparator
Arm Description
Treatment as usual for condition Physiotherapy sessions
Intervention Type
Other
Intervention Name(s)
Somatosensory rehabilitation
Intervention Type
Other
Intervention Name(s)
Usual treatment: physiotherapy
Primary Outcome Measure Information:
Title
McGill Pain Questionnaire
Description
total number and intensity of sensory and affective pain descriptors selected by participant
Time Frame
baseline to 6 month follow-up
Secondary Outcome Measure Information:
Title
Pain subscale of the Patient-Rated Wrist and Hand Evaluation
Description
5 questions rating self-reported pain at rest, with movement, pain with lifting, worst pain and pain frequency.
Time Frame
Baseline to six months
Title
Hamilton Inventory for Complex Regional Pain Syndrome
Description
Includes a both a patient-reported scale addressing symptoms, daily function and psychosocial concerns; and a clinician-based assessment of clinical signs
Time Frame
Baseline to 6 months
Title
Radboud Evaluation of Sensitivity- English version
Description
self-reported evaluation of sensitivity in an area of injury/trauma
Time Frame
Baseline to 6 months
Other Pre-specified Outcome Measures:
Title
10 test
Description
quick form of quantitative sensory testing for light touch sensation and hypersensitivity
Time Frame
Baseline to 3 months
Title
Pain Catastrophizing Scale
Description
Measures pain-related beliefs
Time Frame
Baseline to 6 months
Title
Allodynography
Description
a graphical technique to anatomically map allodynia associated with a specific nerve branch and assess the area and associated pressure threshold
Time Frame
Baseline to 3 months
Title
Infra-red skin temperature measurement asymmetry
Description
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).
Time Frame
Baseline and 3 months
Title
Goniometric measurement of active range of motion (ROM) of the upper extremities
Description
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).
Time Frame
Baseline to 3 months
Title
Dynamometry for grip and pinch strength
Description
bilateral measures of hand grip and pinch strength
Time Frame
Baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy C MacDermid, PhD
Organizational Affiliation
School of Rehabilitation Sciences, McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Science, General Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9G 3L1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22975739
Citation
Packham TL, Fok D, Frederiksen K, Thabane L, Buckley N. Reliability of infrared thermometric measurements of skin temperature in the hand. J Hand Ther. 2012 Oct-Dec;25(4):358-61; quiz 362. doi: 10.1016/j.jht.2012.06.003. Epub 2012 Sep 10.
Results Reference
background
PubMed Identifier
22265445
Citation
Packham T, MacDermid JC, Henry J, Bain JR. The Hamilton Inventory for Complex Regional Pain Syndrome: a cognitive debriefing study of the clinician-based component. J Hand Ther. 2012 Jan-Mar;25(1):97-111; quiz 112. doi: 10.1016/j.jht.2011.09.007.
Results Reference
background
PubMed Identifier
31858880
Citation
Packham TL, Spicher CJ, MacDermid JC, Quintal I, Buckley N. Evaluating a sensitive issue: reliability of a clinical evaluation for allodynia severity. Somatosens Mot Res. 2020 Mar;37(1):22-27. doi: 10.1080/08990220.2019.1704242. Epub 2019 Dec 20.
Results Reference
derived
PubMed Identifier
30908579
Citation
Packham TL, Spicher CJ, MacDermid JC, Buckley ND. Allodynography: Reliability of a New Procedure for Objective Clinical Examination of Static Mechanical Allodynia. Pain Med. 2020 Jan 1;21(1):101-108. doi: 10.1093/pm/pnz045.
Results Reference
derived
PubMed Identifier
35005383
Citation
Packham T, MacDermid J, Bain J, Buckley N. Identification of complex regional pain syndrome in the upper limb: Skin temperature asymmetry after cold pressor test. Can J Pain. 2018 Aug 21;2(1):248-257. doi: 10.1080/24740527.2018.1504283. eCollection 2018.
Results Reference
derived

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Somatosensory Assessment and Rehabilitation of Allodynia (SARA)

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