Clinical trial NCT02070367: Somatosensory Assessment and Rehabilitation of Allodynia (SARA)
Official title: Somatosensory Assessment and Rehabilitation of Allodynia: the SARA Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndrome
Peripheral Nerve Injuries
Hand Fractures
Keywords: allodynia
complex regional pain syndrome
peripheral nerve injuries
clinical measurement properties
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-02-25
Enrollment: 39
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: McGill Pain Questionnaire
timeFrame: baseline to 6 month follow-up
Secondary outcomes:
measure: Pain subscale of the Patient-Rated Wrist and Hand Evaluation
timeFrame: Baseline to six months
measure: Hamilton Inventory for Complex Regional Pain Syndrome
timeFrame: Baseline to 6 months
measure: Radboud Evaluation of Sensitivity- English version
timeFrame: Baseline to 6 months
Other outcomes:
measure: 10 test
timeFrame: Baseline to 3 months
measure: Pain Catastrophizing Scale
timeFrame: Baseline to 6 months
measure: Allodynography
timeFrame: Baseline to 3 months
measure: Infra-red skin temperature measurement asymmetry
timeFrame: Baseline and 3 months
measure: Goniometric measurement of active range of motion (ROM) of the upper extremities
timeFrame: Baseline to 3 months
measure: Dynamometry for grip and pinch strength
timeFrame: Baseline to 3 months
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Science, General Site
state: Ontario
Study officials:
affiliation: School of Rehabilitation Sciences, McMaster University
name: Joy C MacDermid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.