Cerebral Changes Following CTS Treated With Guided Plasticity

Carpal Tunnel Syndrome Clinical Trial

Official title:

Cerebral Changes Following Carpal Tunnel Syndrome Treated With Guided Brain Plasticity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06016049
• Other study ID #: 210817
• Status: Completed
• Phase: N/A
• Start date: July 1, 2009
• Est. completion date: November 1, 2015

Study information

• Verified date: July 2023
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 1, 2015
• Est. primary completion date: November 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• EMLA® adjuvant
cutaneous forearm deafferentation

Behavioral:
• Sensory training
Sensibility training of the median nerve

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Carpal Tunnel Syndrome Symptom Severity Score	score between 1 and 5, with higher scores indicating worse symptoms or function	8 weeks
Primary	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
Secondary	quick-DASH upper extremity symptom score	score between 1-5, higher scores indicating less symptoms	8 weeks
Secondary	2 Point Discrimination (2PD)	mean value of 3 measures indicating touch threshold	8 weeks
Secondary	Sensory conduction velocity	Sensory Nerve Conduction Velocity from nerve conduction studies	8 weeks
Secondary	Sensory conduction amplitude	Sensory Nerve Conduction Amplitude from nerve conduction studies	8 weeks
Secondary	functional MRI dig 1+2	comparison between activation using interaction contrast in S1sensory cortex of the	8 weeks
Secondary	functional MRI dig 5	comparison between activation in the sensory cortex of the little finger (EMLA® vs placebo)	8 weeks