Cerebral Changes Following CTS Treated With Guided Plasticity

NCT06016049 | Completed

• 1 other identifier: 210817
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Keywords

Magnetic Resonance Imaging; Somatosensory Cortex; Anesthesia; Hand

Outcome Measures

Primary Outcomes (2)

• Boston Carpal Tunnel Syndrome Symptom Severity Score

  score between 1 and 5, with higher scores indicating worse symptoms or function

  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)

  8 weeks

Secondary Outcomes (6)

• quick-DASH upper extremity symptom score

  8 weeks

• 2 Point Discrimination (2PD)

  8 weeks

• Sensory conduction velocity

  8 weeks

• Sensory conduction amplitude

  8 weeks

• functional MRI dig 1+2

  8 weeks

Study Arms (2)

EMLA®

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Behavioral: Sensory training

Interventions

EMLA® adjuvant OTHER

cutaneous forearm deafferentation

EMLA®

Sensory training BEHAVIORAL

Sensibility training of the median nerve

EMLA®; Skin cream

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Magnus Flondell, MD PhD

  Institute of Translational Sciences Malmö, Lund University

  PRINCIPAL INVESTIGATOR

• Anders Björkman, MD, Prof.

  Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: August 29, 2023
• Study Start: July 1, 2009
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 29, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share