An interventional study of EMLA® adjuvant and Sensory training in Carpal Tunnel Syndrome, sponsored by Region Skane. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Region Skane · Not applicable, Interventional, and Basic science
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.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
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Exclusion Criteria:
adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity
Other: EMLA® adjuvant · Behavioral: Sensory training
skin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training
Behavioral: Sensory training
cutaneous forearm deafferentation
Sensibility training of the median nerve
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
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
No study locations are listed for this record.
Plan to share: No — data can be shared upon reasonable demand after personal contact.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Region Skane