Cerebral Changes Following CTS Treated With Guided Plasticity

Sponsor

Region Skane (Other)

Overall Status

Completed

CT.gov ID

NCT06016049

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Other: EMLA® adjuvant Behavioral: Sensory training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Cerebral Changes Following Carpal Tunnel Syndrome Treated With Guided Brain Plasticity

Actual Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: EMLA® adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity	Other: EMLA® adjuvant cutaneous forearm deafferentation Behavioral: Sensory training Sensibility training of the median nerve
Placebo Comparator: Skin cream skin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training	Behavioral: Sensory training Sensibility training of the median nerve

Arm

Intervention/Treatment

Active Comparator: EMLA®

adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity

Other: EMLA® adjuvant

cutaneous forearm deafferentation

Behavioral: Sensory training

Sensibility training of the median nerve

Placebo Comparator: Skin cream

skin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training

Behavioral: Sensory training

Sensibility training of the median nerve

Outcome Measures

Primary Outcome Measures

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

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
Sensory conduction amplitude [8 weeks]
Sensory Nerve Conduction Amplitude 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Region Skane

Investigators

Principal Investigator: Magnus Flondell, MD PhD, Institute of Translational Sciences Malmö, Lund University
Study Chair: Anders Björkman, MD, Prof., Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University