Somatosensory Assessment and Rehabilitation of Allodynia (SARA)

NCT02070367 | Completed

• 1 other identifier: 13-798
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndrome; Peripheral Nerve Injuries; Hand Fractures

Keywords

allodynia; complex regional pain syndrome; peripheral nerve injuries; clinical measurement properties

Outcome Measures

Primary Outcomes (1)

• McGill Pain Questionnaire

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

  baseline to 6 month follow-up

Secondary Outcomes (3)

• Pain subscale of the Patient-Rated Wrist and Hand Evaluation

  Baseline to six months

• Hamilton Inventory for Complex Regional Pain Syndrome

  Baseline to 6 months

• Radboud Evaluation of Sensitivity- English version

  Baseline to 6 months

Other Outcomes (6)

• 10 test

  Baseline to 3 months

• Pain Catastrophizing Scale

  Baseline to 6 months

• Allodynography

  Baseline to 3 months

Study Arms (2)

Somatosensory rehabilitation

EXPERIMENTAL

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

Usual treatment

ACTIVE COMPARATOR

Treatment as usual for condition Physiotherapy sessions

Other: Usual treatment: physiotherapy

Interventions

Somatosensory rehabilitation OTHER

Somatosensory rehabilitation

Usual treatment: physiotherapy OTHER

Somatosensory rehabilitation; Usual treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Hamilton Health Science, General Site

Hamilton, Ontario, L9G 3L1, Canada

Location

Related Publications (5)

• 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.

  PMID: 22975739 BACKGROUND

• 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.

  PMID: 22265445 BACKGROUND

• 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.

  PMID: 35005383 DERIVED

• 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.

  PMID: 31858880 DERIVED

• 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.

  PMID: 30908579 DERIVED

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Peripheral Nerve Injuries; Hyperalgesia

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Trauma, Nervous System; Wounds and Injuries; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joy C MacDermid, PhD

  School of Rehabilitation Sciences, McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 25, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

CA (1)