Trial Outcomes & Findings for Comparison of Two Techniques for the Treatment of Carpal Tunnel Syndrome (NCT NCT05468814)

NCT ID: NCT05468814

Last Updated: 2024-09-19

Results Overview

Pain/allodynia in the area of the thenar and/or hypothenar eminences, scar hyperalgesia, pain when supporting the heel of the hand, dysesthesia

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: 3 weeks after surgery
• Results posted on: 2024-09-19

Participant Flow

Not specified. The assignment was randomized

Participant milestones

Measure	Z-plasty It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch. Z-plasty: It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure. Conventional: It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Overall Study STARTED	60	60
Overall Study COMPLETED	55	54
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Measure	Z-plasty It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch. Z-plasty: It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure. Conventional: It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Overall Study Lost to Follow-up	5	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Z-plasty n=55 Participants It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional n=54 Participants It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.	Total n=109 Participants Total of all reporting groups
Age, Continuous	55.5 years STANDARD_DEVIATION 10.8 • n=55 Participants	56.7 years STANDARD_DEVIATION 12.7 • n=54 Participants	56.1 years STANDARD_DEVIATION 11.8 • n=109 Participants
Sex: Female, Male Female	45 Participants n=55 Participants	35 Participants n=54 Participants	80 Participants n=109 Participants
Sex: Female, Male Male	10 Participants n=55 Participants	19 Participants n=54 Participants	29 Participants n=109 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Laterality	29 Number of participants right handed n=55 Participants	32 Number of participants right handed n=54 Participants	61 Number of participants right handed n=109 Participants
Atrophy	1 Participants n=55 Participants	2 Participants n=54 Participants	3 Participants n=109 Participants
Baseline grip strength	16.3 kilograms STANDARD_DEVIATION 8.2 • n=55 Participants	19.6 kilograms STANDARD_DEVIATION 10.4 • n=54 Participants	17.9 kilograms STANDARD_DEVIATION 9.5 • n=109 Participants
Baseline pinch strength	2.9 kilograms STANDARD_DEVIATION 2.2 • n=55 Participants	3.9 kilograms STANDARD_DEVIATION 2.4 • n=54 Participants	3.4 kilograms STANDARD_DEVIATION 2.4 • n=109 Participants
Baseline clinical BCTQ	3.5 units on a scale STANDARD_DEVIATION 0.8 • n=55 Participants	3.3 units on a scale STANDARD_DEVIATION 0.7 • n=54 Participants	3.4 units on a scale STANDARD_DEVIATION 0.8 • n=109 Participants
Baseline functional BCTQ	3.1 units on a scale STANDARD_DEVIATION 0.9 • n=55 Participants	2.8 units on a scale STANDARD_DEVIATION 0.8 • n=54 Participants	3.0 units on a scale STANDARD_DEVIATION 0.9 • n=109 Participants

PRIMARY outcome

Timeframe: 3 weeks after surgery

Pain/allodynia in the area of the thenar and/or hypothenar eminences, scar hyperalgesia, pain when supporting the heel of the hand, dysesthesia

Outcome measures

Measure	Z-plasty n=55 Participants It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional n=54 Participants It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Incidence of Pillar Pain	14 Participants	24 Participants

PRIMARY outcome

Timeframe: 6 months after surgery

Pain/allodynia in the area of the thenar and/or hypothenar eminences, scar hyperalgesia, pain when supporting the heel of the hand, dysesthesia

Outcome measures

Measure	Z-plasty n=55 Participants It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional n=54 Participants It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Incidence of Pillar Pain	5 Participants	9 Participants

SECONDARY outcome

Timeframe: 3 weeks after surgery

Grip strength measured with a dynamometer

Outcome measures

Measure	Z-plasty n=55 Participants It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional n=54 Participants It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Grip Strength	13.8 kilograms Standard Deviation 7.0	15.6 kilograms Standard Deviation 9.5

SECONDARY outcome

Timeframe: 6 months

Grip strength measured with a dynamometer

Outcome measures

Measure	Z-plasty n=55 Participants It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional n=54 Participants It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Grip Strength	18.6 kilograms Standard Deviation 8.9	19.1 kilograms Standard Deviation 9.0

SECONDARY outcome

Timeframe: 3 weeks

Pinch strength measured with a dynamometer

Outcome measures

Measure	Z-plasty n=55 Participants It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional n=54 Participants It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Pinch Strength	3.8 kilograms Standard Deviation 2.8	3.5 kilograms Standard Deviation 2.5

SECONDARY outcome

Timeframe: 6 months

Pinch strength measured with a dynamometer

Outcome measures

Measure	Z-plasty n=55 Participants It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional n=54 Participants It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Pinch Strength	5.4 kilograms Standard Deviation 3.0	5.1 kilograms Standard Deviation 2.4

SECONDARY outcome

Timeframe: 3 weeks after surgery

Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome.

Minimum: 1 (better). Maximum: 5 (worse)

Outcome measures

Measure	Z-plasty n=55 Participants It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional n=54 Participants It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Clinical BCTQ	1.9 units on a scale Standard Deviation 0.8	1.8 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 6 months

Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome.

Minimum: 1 (better). Maximum: 5 (worse)

Outcome measures

Measure	Z-plasty n=55 Participants It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional n=54 Participants It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Functional BCTQ	1.7 units on a scale Standard Deviation 0.8	1.6 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 6 months

Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic (symptoms) of carpal tunnel syndrome.

Minimum: 1 (better). Maximum: 5 (worse)

Outcome measures

Measure	Z-plasty n=55 Participants It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional n=54 Participants It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Clinical BCTQ	1.5 units on a scale Standard Deviation 0.8	1.5 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 3 weeks after surgery

Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic (functionality; daily activities) of carpal tunnel syndrome.

Minimum: 1 (better). Maximum: 5 (worse)

Outcome measures

Measure	Z-plasty n=55 Participants It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.	Conventional n=54 Participants It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Functional BCTQ	2.2 units on a scale Standard Deviation 0.9	2.1 units on a scale Standard Deviation 0.8

Adverse Events

Z-plasty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ms. Irene Calzado Álvarez de Lara

Hospital Universitario Reina Sofía

Phone: +34618093419

Email: ircaalla@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place