Somatosensory Assessment and Rehabilitation of Allodynia (SARA)

Peripheral Nerve Injuries Clinical Trial

— SARA  

Official title:

Somatosensory Assessment and Rehabilitation of Allodynia: the SARA Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070367
• Other study ID #: 13-798
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: August 8, 2017
• Start date: October 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome
• Complex Regional Pain Syndromes
• Hand Fractures
• Hyperalgesia
• Peripheral Nerve Injuries
• Reflex Sympathetic Dystrophy

Intervention

Other:
• Somatosensory rehabilitation

• Usual treatment: physiotherapy

Locations

Country	Name	City	State
Canada	Hamilton Health Science, General Site	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	10 test	quick form of quantitative sensory testing for light touch sensation and hypersensitivity	Baseline to 3 months
Other	Pain Catastrophizing Scale	Measures pain-related beliefs	Baseline to 6 months
Other	Allodynography	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
Other	Infra-red skin temperature measurement asymmetry	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
Other	Goniometric measurement of active range of motion (ROM) of the upper extremities	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
Other	Dynamometry for grip and pinch strength	bilateral measures of hand grip and pinch strength	Baseline to 3 months
Primary	McGill Pain Questionnaire	total number and intensity of sensory and affective pain descriptors selected by participant	baseline to 6 month follow-up
Secondary	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.	Baseline to six months
Secondary	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	Baseline to 6 months
Secondary	Radboud Evaluation of Sensitivity- English version	self-reported evaluation of sensitivity in an area of injury/trauma	Baseline to 6 months