Cerebral Changes Following CTS Treated With Guided Plasticity

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: EMLA® adjuvant; Behavioral: Sensory training

• Registration Number: NCT06016049
• Lead Sponsor: Region Skane

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-01
• Primary Completion: 2015-11-01
• Study Completion: 2015-11-01
• Study First Submitted: 2023-06-11
• Status Verified: 2023-07
• Study First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Study First Posted: 2023-08-29
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMLA®	EMLA® adjuvant	adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity
Skin cream	Sensory training	skin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training
EMLA®	Sensory training	adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity

Primary Outcome Measures

Name	Time	Method
Boston Carpal Tunnel Syndrome Symptom Severity Score	8 weeks	score between 1 and 5, with higher scores indicating worse symptoms or function
functional MRI activation affected vs healthy side (more activation voxels means more active brain area)	8 weeks	The difference in activation using interaction contrast between baseline vs 8 weeks in somatosensory cortex (affected vs healthy side)

Secondary Outcome Measures

Name	Time	Method
Sensory conduction amplitude	8 weeks	Sensory Nerve Conduction Amplitude from nerve conduction studies
quick-DASH upper extremity symptom score	8 weeks	score between 1-5, higher scores indicating less symptoms
2 Point Discrimination (2PD)	8 weeks	mean value of 3 measures indicating touch threshold
Sensory conduction velocity	8 weeks	Sensory Nerve Conduction Velocity from nerve conduction studies
functional MRI dig 1+2	8 weeks	comparison between activation using interaction contrast in S1sensory cortex of the
functional MRI dig 5	8 weeks	comparison between activation in the sensory cortex of the little finger (EMLA® vs placebo)