Comparison of ultrasound-guided needle-knife release of the transverse carpal ligament with glucocorticoid injection in the treatment of carpal tunnel syndrome: a randomized trial

Introduction

Carpal tunnel syndrome (CTS) is currently the most prevalent peripheral nerve entrapment disorder (1), representing an urgent public health issue requiring resolution. Research indicates that fibrosis and thickening of the transverse carpal ligament (TCL) is a primary cause of median nerve compression in CTS (2). This leads to reduced mobility and displacement of the median nerve within the carpal tunnel (3). Glucocorticoid injection therapy is a commonly employed and effective conservative treatment for CTS (4), demonstrating superior short-term efficacy compared to physical therapy (5); however, its long-term outcomes remain uncertain (6). In recent years, with the rapid advancement of needle-knife techniques, ultrasound-guided needle-knife therapy has emerged as a potentially ideal choice for patients due to its advantages of minimal trauma, good therapeutic effect, and lack of impact on patient metabolism (7).

Currently, direct comparative studies evaluating the clinical efficacy and safety of ultrasound-guided needle-knife release of the TCL vs. glucocorticoid injection in patients with mild-to-moderate CTS remain limited. Existing literature predominantly focuses on combined therapies or non-ultrasound-guided needle-knife treatments. Although this study did not specifically target patients with diabetes, our clinical research has shown that, within the context of conservative treatment, both glucocorticoid injections and ultrasound-guided needle-knife therapy are effective for treating mild-to-moderate CTS. Given that glucocorticoid injections may affect patients’ blood glucose levels, and considering that patients with diabetes frequently experience peripheral neuropathy—with CTS being particularly prevalent among them—we conducted a comparative study of the efficacy of ultrasound-guided needle-knife release vs. local glucocorticoid injection.

Given that diabetes is common among CTS patients and their specific clinical needs, there is an urgent requirement for a prospective randomized controlled trial to evaluate the comparative clinical efficacy of ultrasound-guided needle-knife therapy vs. glucocorticoid injection therapy. This study aimed to systematically compare the advantages and disadvantages of both treatment modalities across multiple dimensions, including the degree of symptom improvement, functional recovery speed, and quality of life enhancement. We sought to provide evidence-based medical grounds for formulating individualized treatment strategies for patients with mild-to-moderate CTS. We present this article in accordance with the CONSORT reporting checklist (available at https://qims.amegroups.com/article/view/10.21037/qims-2026-1-0088/rc).

Methods

Eligibility criteria for participants

This study was conducted between September 2025 and January 2026 in the Acupuncture Department of The Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine. The inclusion criteria aligned with the diagnostic features for CTS outlined in the “Clinical Diagnosis and Treatment Guidelines: Physical Medicine and Rehabilitation Volume”: (I) intermittent or persistent pain and numbness in the radial half of the palm covering three and a half fingers, sometimes radiating to the upper limb, worsening in the early morning or at night; (II) reduced or absent sensation on the radial palm surface of the thumb, index, middle, and ring fingers, with positive Tinel’s sign and Phalen’s sign; and (III) electromyography (EMG) diagnosis of mild-to-moderate severity: mild: EMG negative, latency <4.5 ms, abnormal distal sensory latency difference recorded only in the median/ulnar nerve at the ring finger, or abnormal sensory nerve action potentials in at least one of fingers 1–3; moderate: EMG (±), latency ≥4.5 ms, sensory potentials preserved in fingers 1–4 but sensory nerve conduction velocity <40.0 ms, sensory nerve action potentials reduced by >50% compared to the unaffected side. The exclusion criteria were as follows: (I) EMG diagnosis of severe condition, EMG (+), markedly prolonged or absent latency, disappearance of sensory nerve waveform in at least one of fingers 1–4; (II) carpal tunnel stenosis caused by fracture or other space-occupying lesions; (III) concurrent severe cardiovascular or cerebrovascular disease; (IV) thyroid dysfunction, gout, or other immune disorders; (V) pregnant women; and (VI) inability to complete the treatment regimen.

Division

Before admission, patients were informed of two treatment options and were required to sign an informed consent form. Upon presentation, patients’ wrists were randomly allocated to either the ultrasound-guided needle-knife therapy group (treatment group, Group T, 17 carpal tunnels) or the ultrasound-guided glucocorticoid injection group (control group, Group C, 15 carpal tunnels). When treating patients with bilateral CTS as two separate cases, we asked them to complete two separate questionnaires, one for each wrist, based on the symptoms and sensations experienced in each wrist, in order to ensure the independence and completeness of the assessments. A total of three operators were involved, and two doctors were responsible for evaluating the results. Each doctor compiled statistics for half of the results, which were then consolidated by one of them for reporting.

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Ethics Committee of The Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine (approval No. 2025-kl-036) and informed consent was provided by all individual participants.

Intervention

The patient took a seated or supine position, with the affected wrist resting flat on the examination table. The wrist joint was elevated, palm facing upwards, with fingers naturally extended. The Kaplan line was located to prevent inadvertent injury to the superficial palmar arch. The high-frequency ultrasound probe (7–12 MHz) was positioned with its long axis centrally on the palmar aspect of the wrist. The median nerve and TCL were visualized clearly. Care was taken to accurately identify the site where thickening of the TCL compresses the median nerve, causing narrowing of its diameter. The proximal insertion point was determined and marked at the junction of the median nerve and the wrist distal crease. Following local disinfection and draping, the anesthetic (1.5–2 mL 2% lidocaine solution) was injected onto the surface of the median nerve under ultrasound guidance.

• Group T: following carpal tunnel anesthesia, 2 mL of 0.9% sodium chloride solution was injected into the tunnel. After withdrawing the needle and stopping the bleeding, the probe was positioned with its long axis along the palmar midline of the wrist for scanning. The median nerve and the thickening of the TCL were identified, then the 1.2 mm × 80 mm needle-knife was inserted at the mark point to release the TCL. Firstly, the soft tissue overlying the ligament was released, followed by the thickened portion of the TCL. A full-thickness shearing release of the TCL was performed until resistance ceased. The needle-knife was removed and a hemostatic dressing was applied (Figure 1).
• Group C: following carpal tunnel anesthesia, 2 mL of medication was injected into the carpal tunnel (0.5 mL 2% lidocaine + 0.5 mL 0.9% sodium chloride solution + 1 mL 40 mg methylprednisolone). The needle-knife approach and technique were identical to those of Group T, except the needle was inserted only once without performing release maneuvers. After a brief pause, the needle was withdrawn, and the needle-knife removed with hemostasis and dressing applied. Both groups received a single treatment session. Postoperatively, patients were instructed to keep the wound clean and dry for 3 days to prevent infection.

Figure 1 Ultrasound-guided needle-knife release of the TCL therapy. (A) Positioning of the ultrasound probe. (B) Ultrasound-guided needle-knife release of the TCL. Cap, capitate bone; FDS, flexor digitorum superficialis; Met, metacarpal bone; MN, median nerve; TCL, transverse carpal ligament.

A single-blind (patient) method was employed, with several randomized envelopes prepared and labelled according to group assignment. Each envelope represented a wrist and was randomly assigned to either Group C or Group T. Prior to treatment, we informed patients that they should be randomly assigned to either Group C or Group T and treated according to the methods described above. Both groups underwent ultrasound-guided needle-knife insertion and received injections of the same dose of medication or saline solution to ensure that patients were unaware of which group they had been assigned to, thereby achieving a blinded study design and controlling for variables.

Measurements

Carpal tunnel function scale, Numerical Rating Scale (NRS) of numbness and pain, Boston Carpal Tunnel Questionnaire (BCTQ) scale, and 36-Item Short Form Health Survey (SF-36) scale were assessed pre-treatment and at 1 and 3 months post-treatment. Clinical efficacy rates were evaluated using the Kelly criteria. The primary outcome measures were the BCTQ scale and carpal tunnel function scale; the secondary outcome measures were the NRS scale and the SF-36 scale. The carpal tunnel function score ranged from 1 to 4, with 4 being excellent and 1 being poor. The NRS numbness and pain scores ranged from 1 to 10, with higher values indicating greater severity of pain or numbness. The BCTQ comprised two subscales: the Symptom Severity Scale (SSS, 11–55) and the Functional Status Scale (FSS, 8–40), with higher scores indicating greater symptom severity. The SF-36 comprises eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Each subscale employs a weighted scoring system ranging from 0 to 100, calculated as follows: converted score for each dimension = (actual score − minimum possible score for that dimension)/(maximum possible score for that dimension − minimum possible score) × 100.

Clinical efficacy was assessed using the Kelly criteria: cure: complete resolution of clinical symptoms and signs, with full restoration of wrist joint function; marked improvement: the patient’s primary symptoms are largely resolved post-treatment, enabling engagement in primary occupational activities with minimal impact on daily life; improvement: the patient retains some symptoms post-treatment requiring continued management, with significant impairment to primary functional activities and daily living; no improvement: the patient’s clinical symptoms and functional status show no improvement whatsoever (8). Overall response rate = (clinical cure + marked improvement + improvement)/total number of cases × 100%. With postoperative wound pain and infection serving as the criteria for adverse reactions, no adverse reactions were observed in any of the patients.

Statistical analysis

The formula for calculating the sample size was as follows:

n=Z2P(1−P)d2[1]

Where n is the required sample size, Z=1.96 (at a significance level of α=0.05), P is the prevalence, and d is the precision, selected on the basis of the prevalence (9). The total sample size was 35 patients; following screening, 30 patients met the inclusion criteria. Of these, 3 patients withdrew for various reasons, leaving a total of 27 patients included in the study.

All statistical analyses were conducted using GraphPad Prism (GraphPad Software, San Diego, CA, USA) statistical analysis software. Data description: Count data were described using rates and composition ratios; continuous data were described using mean and standard deviation (SD). Comparisons between multiple groups were performed using one-way analysis of variance (ANOVA), followed by Tukey’s multiple comparison test for pairwise comparisons. A P value <0.05 was taken as indicating statistical significance.

Results

Participants information

A total of 27 patients with mild-to-moderate CTS were enrolled, involving 32 carpal tunnels. There were 17 carpal tunnels in Group T and 15 in Group C. Male patients numbered 5 (18.5%), whereas females comprised 22 (81.5%). Ages ranged from 28 to 82 years, with the most prevalent age group being 46–60 years (12 cases, 44.4%). A total of 13 patients (48.2%) had diabetes mellitus. Disease duration ranged from 1 to 96 months, with the most common duration being 1–6 months (10 cases, 37%). Four patients presented with unilateral left-hand involvement, 11 with unilateral right-hand involvement, and 12 with bilateral involvement (44.4%; Table 1, Figure 2).

Figure 2 Patient enrolment flowchart. Group T, the ultrasound-guided needle-knife therapy group; Group C, the ultrasound-guided glucocorticoid injection group. CTS, carpal tunnel syndrome.

Carpal tunnel function scale

In Group T, carpal tunnel function showed significant improvement at both 1 and 3 months post-treatment compared to baseline (P=0.01, P<0.001). In Group C, no statistically significant difference was observed between the two time points (P=0.409). There were no significant differences between the two groups before treatment and 1 month after treatment (P=0.891, P=0.116); however, 3 months after treatment, the carpal tunnel function score in Group T was significantly higher than that in Group C (P=0.009) (Table 2).

NRS of numbness and pain

In Group T, NRS pain and numbness scores showed significant reductions at 1 and 3 months post-treatment compared to baseline (P=0.006, P<0.001). Furthermore, the NRS numbness score at 3 months post-treatment was significantly lower than at 1 month post-treatment (P=0.01). In Group C, NRS pain scores decreased after 1 and 3 months of treatment compared with baseline, but no statistically significant difference was observed (P=0.446, P=0.241). The NRS pain scores in Group C were significantly lower than those in Group T before treatment (P=0.018), but there was no significant difference between the two groups at 1 month and 3 months after treatment (P=0.676, P=0.968). Before treatment, the NRS numbness scores in Group C were significantly lower than those in Group T (P<0.001); however, there was no significant difference between the two groups 1 month after treatment (P=0.718), whereas at 3 months after treatment, the NRS numbness scores in Group T were significantly lower than those in Group C (P=0.003) (Table 3).

BCTQ scale

In Group T, the score of patients’ SSS decreased significantly at 1 month and 3 months post-treatment (P=0.017, P<0.001); FSS scores decreased significantly at 3 months post-treatment (P=0.028). In Group C, mean scores on both the SSS and FSS scales decreased at 1 and 3 months post-treatment, though these reductions did not reach statistical significance compared with pre-treatment levels (P>0.05). In the intergroup comparison, there was no significant difference in SSS scores between the two groups before treatment or 1 month after treatment (P>0.99, P=0.066); however, 3 months after treatment, the SSS score in Group T was significantly lower than that in Group C (P=0.001). There was no significant difference in FSS scores between the two groups before treatment, 1 month after treatment, or 3 months after treatment (P>0.05) (Table 4).

SF-36

In Group T, patients exhibited significantly increased PF, BP, RP, GH, RE, and SF scores at 1 and 3 months post-treatment compared with pre-treatment levels (P<0.05). Notably, the RP score at 3 months post-treatment was significantly higher than that at 1 month post-treatment (P=0.001). Additionally, both VT and MH scores at 3 months post-treatment were significantly higher than pre-treatment levels (P=0.003, P=0.004).

In Group C, no statistically significant differences were observed in PF, RP, BP, GH, VT, RE, SF, or MH scores at 1 and 3 months post-treatment compared with pre-treatment levels (P>0.05), though an upward trend was evident across all parameters (Table 5).

In the intergroup comparison, the PF, RP, BP, and RE scores in Group T were significantly lower than those in Group C before treatment (P<0.05), but there was no significant difference between the two groups at 1 month and 3 months after treatment (P>0.05). There was no significant difference in GH and SF scores between the two groups before treatment (P>0.99, P=0.855), but at 1 month and 3 months after treatment, the GH score in Group T was significantly higher than that in Group C (P=0.027, P<0.001). There was no significant difference in VT scores between the two groups before treatment or at 1 month after treatment (P=0.233, P=0.443), but at 3 months after treatment, the VT score in Group T was significantly higher than that in Group C (P=0.028). There was no significant difference in MH scores between the two groups before treatment, at 1 month after treatment, or at 3 months after treatment (P>0.05).

Kelly criteria

Clinical efficacy was assessed in 27 cases using the Kelly criteria, categorized into four levels: cured, markedly effective, effective, and ineffective. In Group T, 10 cases (58.8%) were cured; 5 cases (29.4%) showed marked improvement; 2 cases (11.8%) were effective; and 0 cases were ineffective.

In Group C, 1 case achieved cure (6.7%); 4 cases showed marked improvement (26.6%); 9 cases showed improvement (60%); and 1 case showed no improvement (6.7%).

Postoperative complications

This study did not report any postoperative complications such as postoperative pain, scar formation, nerve irritation, or bleeding.

Discussion

Among the 27 included patients, 13 had diabetes mellitus, accounting for 48.2% of the cohort. Within diabetic peripheral neuropathy, CTS exhibits the highest incidence rate (10), with a 90% higher prevalence compared to non-diabetic individuals (11). In the clinical management of CTS, 40 mg methylprednisolone once a day is a commonly used and safe glucocorticoid dosage (12,13). However, this amount is sufficient to transiently affect blood glucose levels in both diabetic and non-diabetic patients (14), thereby further increasing the risk of infection (15). A study has shown that glucocorticoid injections can significantly raise blood glucose levels in diabetic patients within 1–2 days of administration (16); therefore, it is imperative to identify a new, conservative treatment that does not affect patients’ blood glucose levels. Findings from another study suggested that intra-articular steroid injections may cause hyperglycemia in patients with diabetes mellitus (17), and patients should be warned of this complication (18).

Minimal invasive carpal tunnel releases are on the rise and are becoming an important alternative to surgical techniques. In a study of cadavers, researchers found that ultrasound-guided minimally invasive thread release of the TCL can effectively prevent nerve and vascular damage (19). Furthermore, carpal tunnel release under high-resolution ultrasound guidance has been shown to reduce the severity and frequency of CTS-related symptoms and remain effective for at least 1 year (20).

Ultrasound-guided needle-knife release of the TCL improves median nerve compression by altering the ligament’s mechanical properties at the physical level. Our pre- and post-treatment questionnaire analysis revealed that, compared to pre-treatment levels, Group T demonstrated significant reductions in NRS pain, NRS numbness, and BCTQ scores at both 1 month and 3 months post-treatment (P<0.05), and Carpal Tunnel Function Score and SF-36 scores showed significant improvement (P<0.05). The efficacy at 3 months post-treatment surpassed that at 1 month, indicating gradual symptom reduction and restoration of carpal tunnel function over time. In Group C, the aforementioned scores improved at both 1 and 3 months post-treatment compared to pre-treatment levels, though there were no statistically significant differences (P>0.05). The efficacy at 3 months post-treatment in this group was virtually indistinguishable from that at 1 month post-treatment. The Kelly criteria also indicated that the overall response rate was higher in group T than Group C.

Glucocorticoid injection therapy does not improve the mechanical properties of carpal tunnel tissues. It merely provides relief from chronic inflammatory processes within the tunnel and reduces median nerve swelling (21), without lowering the ultimate surgical rate (22). Ultrasound-guided needle-knife therapy not only releases the TCL but also further releases the soft tissues above it. This approach addresses the cause of median nerve compression by the TCL while improving the mechanical properties of carpal tunnel tissues, reducing local tissue tension, and thereby alleviating intra-tunnel pressure. Consequently, its efficacy surpasses that of glucocorticoid injection therapy alone.

Minimally invasive TCL release surgery is increasingly becoming the primary treatment for CTS patients, offering superior restoration of grip strength with reduced postoperative pain (23). As a minimally invasive surgical instrument, the needle-knife aligns well with the requirements of minimally invasive release. The integration of ultrasound technology enhances the safety and efficacy of needle-knife therapy (24), providing a potential alternative treatment option. In our pilot study, we combined glucocorticoid injections with needle-knife therapy and achieved satisfactory results. This dual approach reduces median nerve swelling while altering the biomechanical properties within the carpal tunnel, thereby achieving superior therapeutic outcomes. Ultrasound-guided needle-knife release of the TCL is a ‘reproducible’ technique; it does not rely entirely on the clinician’s personal experience, but rather requires a sound grasp of ultrasound technology and anatomical knowledge. The learning curve is relatively short.

Nevertheless, this study has certain limitations, including the relatively small sample size, short follow-up period, lack of detailed records regarding blood glucose fluctuations in diabetic patients, and the absence of ultrasound parameters. In particular, the small sample size may lead to biased statistical results; the short follow-up period does not fully reflect long-term efficacy; and the lack of monitoring of blood glucose fluctuations means that the hypothesis that needle-knife release has no effect on patients’ blood glucose levels cannot be fully verified. Moreover, as needle-knife therapy demonstrates lower efficacy in transecting the TCL compared to open surgery, it may yield suboptimal outcomes for severe CTS patients. Further investigation is required to determine whether needle-knife therapy provides sustained improvement in the long term, and whether the incomplete release of the TCL by this technique leads to an increased recurrence rate. Answers to these questions will depend on longer-term follow-up.

Future studies should increase the sample size, extend the follow-up period, expand the range of measurement parameters, and conduct further comparative efficacy analyses in diabetic populations to determine the optimal treatment regimen.

Conclusions

Ultrasound-guided needle-knife release of the TCL demonstrated superior efficacy compared to glucocorticoid injection; it may serve as an alternative to CTS treatment.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the CONSORT reporting checklist. Available at https://qims.amegroups.com/article/view/10.21037/qims-2026-1-0088/rc

Trial Protocol: Available at https://qims.amegroups.com/article/view/10.21037/qims-2026-1-0088/tp

Data Sharing Statement: Available at https://qims.amegroups.com/article/view/10.21037/qims-2026-1-0088/dss

Funding: This work was supported by the Natural Science Foundation of Fujian Province (No. 2025J01936) and the Open Research Projects in the Department of Traditional Chinese Orthopaedics, Fujian University of Traditional Chinese Medicine (No. XGS2025001).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://qims.amegroups.com/article/view/10.21037/qims-2026-1-0088/coif). All authors report that this work was supported by the Natural Science Foundation of Fujian Province (No. 2025J01936) and the Open Research Projects in the Department of Traditional Chinese Orthopaedics, Fujian University of Traditional Chinese Medicine (No. XGS2025001). The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The trial was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of The Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine (approval No. 2025-kl-036) and informed consent was taken from all individual participants.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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