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Completed

NCT Number: NCT06016049

Cerebral Changes Following CTS Treated With Guided 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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EMLA® adjuvant

Other

cutaneous forearm deafferentation

Sensory training

Behavioral

Sensibility training of the median nerve

Primary outcomes

  1. Boston Carpal Tunnel Syndrome Symptom Severity Score

    Time frame: 8 weeks

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

  2. functional MRI activation affected vs healthy side (more activation voxels means more active brain area)

    Time frame: 8 weeks

    The difference in activation using interaction contrast between baseline vs 8 weeks in somatosensory cortex (affected vs healthy side)

Secondary outcomes

  1. quick-DASH upper extremity symptom score

    Time frame: 8 weeks

    score between 1-5, higher scores indicating less symptoms

  2. 2 Point Discrimination (2PD)

    Time frame: 8 weeks

    mean value of 3 measures indicating touch threshold

  3. Sensory conduction velocity

    Time frame: 8 weeks

    Sensory Nerve Conduction Velocity from nerve conduction studies

  4. Sensory conduction amplitude

    Time frame: 8 weeks

    Sensory Nerve Conduction Amplitude from nerve conduction studies

  5. functional MRI dig 1+2

    Time frame: 8 weeks

    comparison between activation using interaction contrast in S1sensory cortex of the

  6. functional MRI dig 5

    Time frame: 8 weeks

    comparison between activation in the sensory cortex of the little finger (EMLA® vs placebo)

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Cerebral Changes Following Carpal Tunnel Syndrome Treated With Guided Brain Plasticity

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Aug 29, 2023
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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