Morphological and functional changes of the median nerve after neurolysis for carpal tunnel syndrome

Completed

• Conditions: carpal tunnel syndrome; median nerve neuropathy; 10034606

• Registration Number: NL-OMON37253
• Lead Sponsor: Atrium Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Age > 18 years
2. Clinical signs of carpal tunnel syndrome, as described by the AAN criteria for CTS: paresthesias, pain, swelling, weakness, or clumsiness of the hand (digit 1-4) provoked or worsened by sleep, sustained hand or arm position, or repetitive action of the hand or wrist that is mitigated by changing posture or by shaking of the hand; sensory deficits in the median innervated region of the hand; and motor deficit or hypotrophy of the median innervated thenar muscles
3. Electrophysiological evidence of CTS (see below)
4. Surgery is the preferred treatment modality
5. Patients having bilateral CTS can only participate with the most affected side.
6. Criterium for the time interval between initial exam and surgery: within 5 weeks
7. Able to read and understand written questionnaires (in Dutch)
8. Informed written consent

Exclusion Criteria

1. Unable to follow up
2. Prior surgery or trauma on the wrist / median nerve
3. Previous surgery for carpal tunnel syndrome; previous surgery for CTS on the contralaterale side is not an exclusion criterium.
4. Treatment with splints or corticosteroids the past 6 months.
5. Clinical or electrophysiological evidence of conditions that could mimic CTS or interfere with its
validation (cervical radiculopathy, brachial plexopathy, thoracic outlet syndrome, pronator teres syndrome, ulnar neuropathy, polyneuropathy, Raynaud*s disease, sympathic dystrophy)
6. Underlying causes of CTS: diabetes, thyroid disease, rheumatoid arthritis, chronic renal failure
treated by hemodialysis, space-occupying lesions a the volar wrist. A bifid median nerve of persistant median artery are no exclusion criteria.
7. Pregnancy

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measures<br /><br><br /><br>1. Change in intraneural vascularisation after neurolysis<br /><br>2. Change in cross sectional area of the median nerve after neurolysis<br /><br>3. Change in swelling and flattening ratio of the median nerve after neurolysis<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Correlation of ultrasonographic changes and clinical/nerve conduction changes<br /><br>after neurolysis.</p><br>