Cerebral Changes Following CTS Treated With Guided Plasticity

NCT ID: NCT06016049

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-01
• Study Completion Date: 2015-11-01

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

EMLA®

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

Group Type: ACTIVE_COMPARATOR

EMLA® adjuvant

Intervention Type: OTHER

cutaneous forearm deafferentation

Sensory training

Intervention Type: BEHAVIORAL

Sensibility training of the median nerve

Skin cream

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

Group Type: PLACEBO_COMPARATOR

Sensory training

Intervention Type: BEHAVIORAL

Sensibility training of the median nerve

Interventions

EMLA® adjuvant

cutaneous forearm deafferentation

Intervention Type: OTHER

Sensory training

Sensibility training of the median nerve

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magnus Flondell, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Translational Sciences Malmö, Lund University

Anders Björkman, MD, Prof.

Role: STUDY_CHAIR

Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University

Other Identifiers

210817

Identifier Type: -

Identifier Source: org_study_id