Carpal Tunnel Syndrome
Conditions
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
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.
It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Pillar Pain | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip Strength | 3 weeks after surgery | Grip strength measured with a dynamometer |
| Pinch Strength | 3 weeks | Pinch strength measured with a dynamometer |
| Clinical BCTQ | 3 weeks after surgery | Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse) |
| Functional BCTQ | 6 months | Boston 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
| Arm | Count |
|---|---|
| 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 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 6 |
Baseline characteristics
| Characteristic | Z-plasty | Conventional | Total |
|---|---|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 10.8 | 56.7 years STANDARD_DEVIATION 12.7 | 56.1 years STANDARD_DEVIATION 11.8 |
| Atrophy | 1 Participants | 2 Participants | 3 Participants |
| Baseline clinical BCTQ | 3.5 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 BCTQ | 3.1 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 strength | 16.3 kilograms STANDARD_DEVIATION 8.2 | 19.6 kilograms STANDARD_DEVIATION 10.4 | 17.9 kilograms STANDARD_DEVIATION 9.5 |
| Baseline pinch strength | 2.9 kilograms STANDARD_DEVIATION 2.2 | 3.9 kilograms STANDARD_DEVIATION 2.4 | 3.4 kilograms STANDARD_DEVIATION 2.4 |
| Laterality | 29 Number of participants right handed | 32 Number of participants right handed | 61 Number of participants right handed |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 45 Participants | 35 Participants | 80 Participants |
| Sex: Female, Male Male | 10 Participants | 19 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 54 |
| other Total, other adverse events | 0 / 55 | 0 / 54 |
| serious Total, serious adverse events | 0 / 55 | 0 / 54 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Z-plasty | Incidence of Pillar Pain | 5 Participants |
| Conventional | Incidence of Pillar Pain | 9 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Z-plasty | Incidence of Pillar Pain | 14 Participants |
| Conventional | Incidence of Pillar Pain | 24 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Z-plasty | Clinical BCTQ | 1.5 units on a scale | Standard Deviation 0.8 |
| Conventional | Clinical BCTQ | 1.5 units on a scale | Standard Deviation 0.7 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Z-plasty | Clinical BCTQ | 1.9 units on a scale | Standard Deviation 0.8 |
| Conventional | Clinical BCTQ | 1.8 units on a scale | Standard Deviation 0.7 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Z-plasty | Functional BCTQ | 1.7 units on a scale | Standard Deviation 0.8 |
| Conventional | Functional BCTQ | 1.6 units on a scale | Standard Deviation 0.7 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Z-plasty | Functional BCTQ | 2.2 units on a scale | Standard Deviation 0.9 |
| Conventional | Functional BCTQ | 2.1 units on a scale | Standard Deviation 0.8 |
Grip Strength
Grip strength measured with a dynamometer
Time frame: 3 weeks after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Z-plasty | Grip Strength | 13.8 kilograms | Standard Deviation 7 |
| Conventional | Grip Strength | 15.6 kilograms | Standard Deviation 9.5 |
Grip Strength
Grip strength measured with a dynamometer
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Z-plasty | Grip Strength | 18.6 kilograms | Standard Deviation 8.9 |
| Conventional | Grip Strength | 19.1 kilograms | Standard Deviation 9 |
Pinch Strength
Pinch strength measured with a dynamometer
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Z-plasty | Pinch Strength | 3.8 kilograms | Standard Deviation 2.8 |
| Conventional | Pinch Strength | 3.5 kilograms | Standard Deviation 2.5 |
Pinch Strength
Pinch strength measured with a dynamometer
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Z-plasty | Pinch Strength | 5.4 kilograms | Standard Deviation 3 |
| Conventional | Pinch Strength | 5.1 kilograms | Standard Deviation 2.4 |