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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMLA® | Active Comparator | adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity |
|
| Skin cream | Placebo Comparator | skin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMLA® adjuvant | Other | cutaneous forearm deafferentation |
| |
| Sensory training |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Carpal Tunnel Syndrome Symptom Severity Score | score between 1 and 5, with higher scores indicating worse symptoms or function | 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) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| quick-DASH upper extremity symptom score | score between 1-5, higher scores indicating less symptoms | 8 weeks |
| 2 Point Discrimination (2PD) | mean value of 3 measures indicating touch threshold |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Flondell, MD PhD | Institute of Translational Sciences Malmö, Lund University | Principal Investigator |
| Anders Björkman, MD, Prof. | Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University | Study Chair |
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data can be shared upon reasonable demand after personal contact.
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| Behavioral |
Sensibility training of the median nerve |
|
| 8 weeks |
| Sensory conduction velocity | Sensory Nerve Conduction Velocity from nerve conduction studies | 8 weeks |
| Sensory conduction amplitude | Sensory Nerve Conduction Amplitude from nerve conduction studies | 8 weeks |
| functional MRI dig 1+2 | comparison between activation using interaction contrast in S1sensory cortex of the | 8 weeks |
| functional MRI dig 5 | comparison between activation in the sensory cortex of the little finger (EMLA® vs placebo) | 8 weeks |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |