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Comparison of Two Techniques for the Treatment of Carpal Tunnel Syndrome

Comparison of Two Techniques for the Treatment of Carpal Tunnel Syndrome: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05468814
Acronym
STCCOT
Enrollment
120
Registered
2022-07-21
Start date
2022-07-18
Completion date
2023-05-28
Last updated
2024-09-19

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

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome, Pillar pain, Grip strength, Pincer strength

Brief summary

The main objective of this study is to compare the complete section of the transverse carpal ligament with another median nerve release technique and to determine if the incidence of post-surgical pillar pain is lower for either of the two surgical techniques. As secondary objectives, we also seek to determine if the postsurgical grip and pincer strength and the Boston Carpal Tunnel Questionnaire (BCTQ) score are better for either of the two surgical techniques.

Detailed description

It will be a randomized clinical trial with a sample size of about 80 patients. It will have two study groups: the experimental group (in which 40 patients will be included) where a Z-plasty technique will be applied; and the control group (another 40 patients) who will undergo the conventional technique of complete section of the transverse carpal ligament. The main variable will be the presence or absence of post-surgical pillar pain and, as secondary variables, the recovery of grip and pincer strength and the improvement in the BCTQ score will be studied. The study population will be patients with carpal tunnel syndrome diagnosed clinically (pain and paresthesias in the first three fingers and radial edge of the fourth finger, nocturnal paresthesias, thenar muscle atrophy, loss of thumb opposition), examination (Durkan's signs , Phalen and Tinnel positive) and with a positive electromyogram test classified as moderate or severe. As inclusion criteria, patients \>18 years of age with moderate-severe carpal tunnel syndrome whose symptoms hinder the daily activities of the patient and who have failed conservative treatment will be considered. Those who have already undergone a previous surgical intervention for carpal tunnel syndrome in the same hand, who have traumatic or congenital sequelae in the hand or who do not have the capacity to understand the process or the tests to be performed will be excluded. The total expected duration of each patient in the study will be 6 months and the following visits and procedures will be carried out: clinical study and quality questionnaires prior to surgery and post-surgical follow-up at 3-4 weeks and at 6 months in consultation, with repetition of clinical examination and quality questionnaires. The incidence of pillar pain (defined as pain/sensation of allodynia in the area of the thenar and/or hypothenar eminence, hyperalgesia in the scar, pain when supporting the heel of the hand, dysesthesia at rest) will be analyzed applying the principle of intention to treat, using the Mann Whitney test to compare the score in the tests used.

Interventions

PROCEDUREZ-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.

PROCEDUREConventional

It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.

Sponsors

Hospital Universitario Reina Sofia de Cordoba
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

This is a double-blind study, in which both the patient and the evaluating staff are unaware of the surgical technique used (both surgeons will perform both techniques). A traumatologist will analyze (before and after surgery) the clinic, strength and satisfaction of the patients.

Intervention model description

Patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, using a computer-generated random assignment list

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years * Moderate-severe carpal tunnel syndrome * Symptoms that hinder the patient's daily activities * Correct conservative treatment without success

Exclusion criteria

* Previous surgical intervention for carpal tunnel syndrome * Traumatic or congenital sequelae of the hand * Incompetence to understand the process and the tests to be carried out

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Pillar Pain3 weeks after surgeryPain/allodynia in the area of the thenar and/or hypothenar eminences, scar hyperalgesia, pain when supporting the heel of the hand, dysesthesia

Secondary

MeasureTime frameDescription
Grip Strength3 weeks after surgeryGrip strength measured with a dynamometer
Pinch Strength3 weeksPinch strength measured with a dynamometer
Clinical BCTQ3 weeks after surgeryBoston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse)
Functional BCTQ6 monthsBoston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse)

Countries

Spain

Participant flow

Pre-assignment details

Not specified. The assignment was randomized

Participants by arm

ArmCount
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.
55
Conventional
It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
54
Total109

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up56

Baseline characteristics

CharacteristicZ-plastyConventionalTotal
Age, Continuous55.5 years
STANDARD_DEVIATION 10.8
56.7 years
STANDARD_DEVIATION 12.7
56.1 years
STANDARD_DEVIATION 11.8
Atrophy1 Participants2 Participants3 Participants
Baseline clinical BCTQ3.5 units on a scale
STANDARD_DEVIATION 0.8
3.3 units on a scale
STANDARD_DEVIATION 0.7
3.4 units on a scale
STANDARD_DEVIATION 0.8
Baseline functional BCTQ3.1 units on a scale
STANDARD_DEVIATION 0.9
2.8 units on a scale
STANDARD_DEVIATION 0.8
3.0 units on a scale
STANDARD_DEVIATION 0.9
Baseline grip strength16.3 kilograms
STANDARD_DEVIATION 8.2
19.6 kilograms
STANDARD_DEVIATION 10.4
17.9 kilograms
STANDARD_DEVIATION 9.5
Baseline pinch strength2.9 kilograms
STANDARD_DEVIATION 2.2
3.9 kilograms
STANDARD_DEVIATION 2.4
3.4 kilograms
STANDARD_DEVIATION 2.4
Laterality29 Number of participants right handed32 Number of participants right handed61 Number of participants right handed
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
45 Participants35 Participants80 Participants
Sex: Female, Male
Male
10 Participants19 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 550 / 54
other
Total, other adverse events
0 / 550 / 54
serious
Total, serious adverse events
0 / 550 / 54

Outcome results

Primary

Incidence of Pillar Pain

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

Time frame: 6 months after surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Z-plastyIncidence of Pillar Pain5 Participants
ConventionalIncidence of Pillar Pain9 Participants
Primary

Incidence of Pillar Pain

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

Time frame: 3 weeks after surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Z-plastyIncidence of Pillar Pain14 Participants
ConventionalIncidence of Pillar Pain24 Participants
Secondary

Clinical BCTQ

Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic (symptoms) of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse)

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Z-plastyClinical BCTQ1.5 units on a scaleStandard Deviation 0.8
ConventionalClinical BCTQ1.5 units on a scaleStandard Deviation 0.7
Secondary

Clinical BCTQ

Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse)

Time frame: 3 weeks after surgery

ArmMeasureValue (MEAN)Dispersion
Z-plastyClinical BCTQ1.9 units on a scaleStandard Deviation 0.8
ConventionalClinical BCTQ1.8 units on a scaleStandard Deviation 0.7
Secondary

Functional BCTQ

Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse)

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Z-plastyFunctional BCTQ1.7 units on a scaleStandard Deviation 0.8
ConventionalFunctional BCTQ1.6 units on a scaleStandard Deviation 0.7
Secondary

Functional BCTQ

Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic (functionality; daily activities) of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse)

Time frame: 3 weeks after surgery

ArmMeasureValue (MEAN)Dispersion
Z-plastyFunctional BCTQ2.2 units on a scaleStandard Deviation 0.9
ConventionalFunctional BCTQ2.1 units on a scaleStandard Deviation 0.8
Secondary

Grip Strength

Grip strength measured with a dynamometer

Time frame: 3 weeks after surgery

ArmMeasureValue (MEAN)Dispersion
Z-plastyGrip Strength13.8 kilogramsStandard Deviation 7
ConventionalGrip Strength15.6 kilogramsStandard Deviation 9.5
Secondary

Grip Strength

Grip strength measured with a dynamometer

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Z-plastyGrip Strength18.6 kilogramsStandard Deviation 8.9
ConventionalGrip Strength19.1 kilogramsStandard Deviation 9
Secondary

Pinch Strength

Pinch strength measured with a dynamometer

Time frame: 3 weeks

ArmMeasureValue (MEAN)Dispersion
Z-plastyPinch Strength3.8 kilogramsStandard Deviation 2.8
ConventionalPinch Strength3.5 kilogramsStandard Deviation 2.5
Secondary

Pinch Strength

Pinch strength measured with a dynamometer

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Z-plastyPinch Strength5.4 kilogramsStandard Deviation 3
ConventionalPinch Strength5.1 kilogramsStandard Deviation 2.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026