Efficacy of Combining Ultrasound-Guided Needle Release of Transverse Carpal Ligament and Median Nerve Dextrose Water Hydrodissection for Carpal Tunnel Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorShin Kong Wu Ho-Su Memorial Hospital

About this trial

Carpal tunnel syndrome (CTS) is a common musculoskeletal disorder, which is caused by compression of the median nerve as it travels through the wrist. There are several treatments for CTS, including conservative and surgical options. Though local corticosteroid injection has been considered more effective than physical therapy for treatment of CTS and has significant short-term benefits, long term benefits are not evidenced. Several studies in recent years reported significantly superior longer-term benefit of D5W and PRP compared with corticosteroid injections and other conservative managements. In addition, percutaneous release of the transverse carpal ligament (TCL) was developed to treat CTS in recent years. Because the effectiveness of the recently developed techniques in treating CTS has not been well established, the investigators aim to investigate whether combining US-guided partial release of the transverse carpal ligament with a needle plus D5W hydrodissection is more beneficial for CTS comparing to either treatment alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age between 20 to 80 years old

diagnosed with CTS on the basis of clinical condition and an electrophysiological analysis

the NRS of pain or paresthesia≧3

with symptoms lasting for a minimum of 3 months.

Disqualifiers

history of polyneuropathy, thoracic outlet syndrome, brachial plexopathy, or inflammatory arthropathy

onset of CTS during pregnancy, hypothyroidism, or systemic infection

previous corticosteroid injection or wrist surgery for CTS

hypersensitivity to dextrose injection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active Comparator: US-guided D5W perineural hydrodissection alone, group A

    Procedure/Surgery

    Patients in the group A will receive 1 session of ultrasound-guided perineural injection with 5ml D5W.

  • Active Comparator: US guided partial release of the TCL with a needle + D5W injection (to TCL), group B

    Procedure/Surgery

    Patients in the group B will receive 1 session of ultrasound-guided partial release of the TCL with a needle plus D5W injection to TCL.

  • Active Comparator: US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissection, group C

    Procedure/Surgery

    Patients in the group C will receive 1 session of the treatment combining group A and group B. Hydrodissection of the median nerve will be performed before TCL release.

Treatment groups

102 Participants
are divided into 3 treatment groups
Group A: US-guided D5W perineural hydrodissection alone, group AActive comparator 1 intervention
Group B: US guided partial release of the TCL with a needle + D5W injection (to TCL), group BActive comparator 1 intervention
Group C: US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a widely applied patient-reported tool for assessing the severity of carpal tunnel syndrome. This instrument consists of two sections: the Symptom Severity Scale (SSS), comprising 11 questions, and the Functional Status Scale (FSS), containing 8 items. Both scales use a 1 to 5 rating system. The minimum score is 19, and maximum value is 95. Higher scores mean a worse outcome.

Time frame
baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.

Secondary outcomes

1

Numeric rating scale (NRS)

Pain or paresthesia severity will be assessed using the NRS, ranging from 0 (no pain and no paresthesia) to 10 (the worst imaginable pain or abnormal sensation).

Time frame
baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.
2

Cross-sectional area (CSA)

Cross-sectional area (CSA) of the median nerve: The CSA of the median nerve will be assessed with an freehand tracing tool at the level of the scaphoid-pisiform, a site where median nerve swelling provides a consistent parameter for post-injection monitoring. Each measurement will be performed three times, and the average value is used for subsequent analysis.

Time frame
baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.
3

Electrophysiological measurement

Assessment of the antidromic sensory nerve conduction velocity (SNCV) and distal motor latency (DML) of the median nerve will be conducted following established protocols. For SNCV measurement, surface electrodes is placed over the proximal and distal interphalangeal joints of the second digit, serving as the active and reference electrodes, respectively, with electrical stimulation applied 14 cm proximal to the active electrode along the course of the median nerve. For DML evaluation, the active electrode is positioned over the abductor pollicis brevis muscle, while the reference electrode is placed at the distal muscle-tendon junction; the median nerve is stimulated 8 cm proximal to the active electrode.

Time frame
baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.
4

Tip pinch strength

Tip pinch strength, defined as the contact between the thumb pulp and index finger pulp, was assessed using a calibrated B\&L pinch meter (B\&L Engineering). Participants were seated with the shoulder adducted and in a neutral rotational position, the elbow flexed at 90 degrees, and the forearm and wrist placed in pronation to facilitate the measurement. Each subject performed three maximum-effort trials, with a one-minute rest period between each trial to prevent muscle fatigue. The mean value from the three trials was calculated for further analysis.

Time frame
baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.

Other outcomes

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