Cerebral Changes Following CTS Treated With Guided Plasticity

Cerebral Changes Following Carpal Tunnel Syndrome Treated With Guided Brain Plasticity

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: EMLA® adjuvant; Behavioral: Sensory training

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: June 11, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Hand; Anesthesia; Somatosensory Cortex
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 210817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data can be shared upon reasonable demand after personal contact.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No