Cerebral Changes Following CTS Treated With Guided Plasticity

Region Skane70 enrolled

Overview

70 patients with mild to moderate Carpal tunnel Syndrome (CTS) including 24 patients with unilateral CTS were randomized to treatment with ipsilateral cutaneous forearm deafferentation with an anesthetic cream (EMLA®) or placebo during 8 weeks. Patient-rated outcomes was assessed using the symptom severity scale from the Boston carpal tunnel syndrome questionnaire (BCTQ) and the disability of arm, shoulder and hand questionnaire(Quick-DASH). Clinically patients were assessed for tactile discrimination and dexterity and nerve conduction studies (NCS). Cortical activation during sensory stimulation was evaluated with functional magnetic resonance imaging (fMRI) at 3T. Assessments were performed at baseline, after 90 min of initial treatment, and after 8 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Carpal Tunnel Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * symptoms of CTS for more than 3 months * classic or probable CTS according to Katz' hand diagram (2, 27) * clinical signs of unilateral CTS with a positive Tinel's and Phalen's test * age between 18 and 70 years * nerve conduction studies (NCS) with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less on the affected side and of more than 43 m/s on the contralateral side * no contraindications for MR examinations. Exclusion Criteria: * bilateral symptoms * having been operated for CTS previously * prior wrist or carpal fracture * diabetes * thyroid disease * rheumatoid arthritis * neurological disease * drug abuse * complete conduction block on electroneurography or prior regular exposure to hand-held vibrating tools.

Outcomes

Primary Outcomes

Boston Carpal Tunnel Syndrome Symptom Severity Score

score between 1 and 5, with higher scores indicating worse symptoms or function

Time frame: 8 weeks

functional MRI activation affected vs healthy side (more activation voxels means more active brain area)

The difference in activation using interaction contrast between baseline vs 8 weeks in somatosensory cortex (affected vs healthy side)

Time frame: 8 weeks

Secondary Outcomes

quick-DASH upper extremity symptom score

score between 1-5, higher scores indicating less symptoms

Time frame: 8 weeks

2 Point Discrimination (2PD)

mean value of 3 measures indicating touch threshold

Time frame: 8 weeks

Sensory conduction velocity

Sensory Nerve Conduction Velocity from nerve conduction studies

Time frame: 8 weeks

Sensory conduction amplitude

Sensory Nerve Conduction Amplitude from nerve conduction studies

Time frame: 8 weeks

functional MRI dig 1+2

comparison between activation using interaction contrast in S1sensory cortex of the

Time frame: 8 weeks

functional MRI dig 5

comparison between activation in the sensory cortex of the little finger (EMLA® vs placebo)

Time frame: 8 weeks