Somatosensory Assessment and Rehabilitation of Allodynia (SARA)

Hamilton Health Sciences (HHS)

Status: Completed

Conditions: Hand Fractures; Peripheral Nerve Injuries; Complex Regional Pain Syndrome

Treatments: Other: Usual treatment: physiotherapy; Other: Somatosensory rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02070367

13-798

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

Somatosensory rehabilitation

Experimental group

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:

Other: Usual treatment: physiotherapy

Other: Somatosensory rehabilitation

Usual treatment

Active Comparator group

Description:

Treatment as usual for condition Physiotherapy sessions

Treatment:

Other: Usual treatment: physiotherapy