Morphologic and functional changes of the median nerve and carpal tunnel after primary carpal tunnel surgery

Morphologic and functional changes of the median nerve and carpal tunnel after primary carpal tunnel surgery - MFCCTS study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46702

Enrollment

Registered

2018-10-03

Start date

2019-03-18

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal tunnel syndrome nerve entrapment in the wrist

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: mentally competent men and women of 16 years or older who underwent an open carpal tunnel release for CTS less than half a year ago. Furthermore, subjects must understand and be able to communicate in the Dutch language.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - No nerve conduction studies and ultrasonography performed prior to the carpal tunnel release - Severe polyneuropathy affecting the operated extremity - Cervical radiculopathy on the operated side - Cerebral diseases affecting the operated extremity - Other neuropathies affecting hand function in the operated extremity

Design outcomes

Primary

Measure	Time frame
The main study parameters are morphologic and electrophysiological findings of the median nerve and carpal tunnel, and the comparison of these findings between patients with and without symptoms. Ultrasonograpy(US): - Cross-sectional area of the median nerve halfway at the forearm and at the carpal tunnel inlet and outlet. - Qualitative aspect of the median nerve with assessment of nerve echogenicity, vascularization, the aspect and thickness of the epineurial rim and perineurial fascicle ensheathing. - Qualitatieve assessment of any anatomical changes related to the median nerve in the surgical region (e.g. scarring, hematoma, aspect of the ligament, etc.). Nerve conduction studies(NCS): - Motor and sensory nerve conduction velocities of the median nerve in the forearm, wrist and palm of the hand segments. - Sensory nerve action potential(SNAP) amplitudes of the 3rd and 4th digits. - Distal motor latency (DML) of the median nerve, with standard stimulation site at 6 cm. - Compound muscle action potential (CMAP) amplitude of the abductor pollicis brevis muscle. - Sensory latency difference of the median nerve compared to the ulnar nerve to the 4th digit.	—

Measure

Time frame

The main study parameters are morphologic and electrophysiological findings of the median nerve and carpal tunnel, and the comparison of these findings between patients with and without symptoms. Ultrasonograpy(US): - Cross-sectional area of the median nerve halfway at the forearm and at the carpal tunnel inlet and outlet. - Qualitative aspect of the median nerve with assessment of nerve echogenicity, vascularization, the aspect and thickness of the epineurial rim and perineurial fascicle ensheathing. - Qualitatieve assessment of any anatomical changes related to the median nerve in the surgical region (e.g. scarring, hematoma, aspect of the ligament, etc.). Nerve conduction studies(NCS): - Motor and sensory nerve conduction velocities of the median nerve in the forearm, wrist and palm of the hand segments. - Sensory nerve action potential(SNAP) amplitudes of the 3rd and 4th digits. - Distal motor latency (DML) of the median nerve, with standard stimulation site at 6 cm. - Compound muscle action potential (CMAP) amplitude of the abductor pollicis brevis muscle. - Sensory latency difference of the median nerve compared to the ulnar nerve to the 4th digit.

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Secondary

Measure	Time frame
- Difference in US(CSA) and NCS findings(NCV, SNAP amplitude, CMAP amplitude, DML) preoperative and postoperative for the total group. - Differences in US and NCS findings for subgroups based on severity of clinical symptoms, and additionally on differences in the extent of NCS abnormalities preoperative(mild, moderate and severe CTS) . - Outcome after CTS measured with the BCTQ and Quick DASH questionnaire correlated to the postoperative US and NCS findings.	—

Measure

Time frame

- Difference in US(CSA) and NCS findings(NCV, SNAP amplitude, CMAP amplitude, DML) preoperative and postoperative for the total group. - Differences in US and NCS findings for subgroups based on severity of clinical symptoms, and additionally on differences in the extent of NCS abnormalities preoperative(mild, moderate and severe CTS) . - Outcome after CTS measured with the BCTQ and Quick DASH questionnaire correlated to the postoperative US and NCS findings.

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Countries

Netherlands

Outcome results