Comparison of Corticosteroid Injection, Nighttime Splinting, or Their Combination for Initial Treatment of Moderate-to-Severe Carpal Tunnel Syndrome

Official title

Comparison of Corticosteroid Injection, Nighttime Splinting, or Their Combination for Initial Treatment of Moderate-to-Severe Carpal Tunnel Syndrome: A Pragmatic, Three-Armed, Open-Label, Multicenter, Randomized Clinical Trial

Overview

The goal of this clinical trial is to compare the efficacy of corticosteroid injection, night splinting, and their combined use as initial treatments for adults with moderate to severe carpal tunnel syndrome (CTS), and to assess the safety and tolerability of these interventions. The primary research questions include: * Doe corticosteroid injection, night splinting, and their combined use as initial treatments reduce the need for surgery in participants with moderate to severe CTS? * How do these interventions affect the improvement of patient symptoms? Participants will: * Receive corticosteroid injection, night splinting, or their combination as initial treatments. * Visit the clinic once every 6 weeks over a period of one year for assessments and dynamic adjustment of the treatment plan. * Undergo periodic assessments of wrist function, quality of life, and sleep quality using standardized questionnaires.

Interventions

• Device Nighttime Splinting
  Nighttime splinting for 6 weeks.
• Drug Corticosteroid Injection
  Local corticosteroid injection (triamcinolone acetonide 40mg). A single injection of triamcinolone acetonide 40mg mixed with an equal volume of 1% lidocaine is administered. The injection is performed under ultrasound guidance and anatomical landmarks to target the proximal carpal tunnel. With the wrist extended, the needle is typically inserted on the ulnar side of the palmaris longus tendon, approximately 1 cm proximal to the wrist crease. If blood is aspirated or the patient reports paresthes
• Other Evaluation and Dynamic Adjustment
  6 weeks later, all patients will undergo evaluation of their initial treatment. Further therapeutic decisions will be made based on physician assessment, including: continuing nighttime splinting, administering corticosteroid injections to patients who initially received only the splint, adding nighttime splinting for patients initially received only corticosteroid injections, and transitioning from nighttime splint use to continuous wear. Subsequently, evaluations will be conducted every 6 week

Primary outcome measures

• Surgical rate within 52 weeks [Time frame: 52 weeks]

Secondary outcome measures (6)

• Change from baseline in BCTQ symptom severity subscale [Time frame: 0,6,12,24,52 weeks]
• Change from baseline in BCTQ function status subscale [Time frame: 0,6,12,24,52 weeks]
• Change from baseline of EQ-VAS [Time frame: 0,6,12,24,52 weeks]
• Change from baseline of PSQI [Time frame: 0,6,12,24,52 weeks]
• Change from baseline of the cross-sectional area of the median nerve [Time frame: 0,52 weeks]
• The incidence rate of clinical and electrophysiological changes indicative of new-onset axonal loss or denervation within 52 weeks [Time frame: 52 weeks]

Eligibility criteria

Inclusion criteria

• Patients aged no less than 18 years old with idiopathic carpal tunnel syndrome of the target side diagnosed by a specialist according to the Katz diagnostic criteria;
• The current episode has occurred within 6 weeks without treatment before eligibility assessment, and the target side has moderate-to-severe symptoms.

Exclusion criteria

• Patients who have plan for surgical treatment on his or her CTS within the following 6 months;
• Any secodary CTS caused by comorbid diseases, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, CPPD (calcium pyrophosphate dihydrate deposition disease), etc.;
• History of fracture or surgery on the target side of the wrist;
• Bilateral CTS with moderate or severe symptoms in both hands;
• Received corticosteroid injections in the wrist within the past 6 months;
• Patients who are unable to wear a splint due to trauma or other reasons;
• Patients with clinical manifestations or electrophysiological changes indicative of significant axonal loss or denervation, including thenar muscle atrophy, sensory loss (two-point discrimination greater than 8 mm), absence of SNAP (sensory nerve action potential), absence of CMAP (compound muscle action potential) in the thenar muscles, etc.;
• Patients who require long-term use of any form of analgesic medication, such as NSAIDs (nonsteroidal anti-inflammatory drugs), opioids, acetaminophen, etc.;
• Patients who have used NSAIDs, opioids (e.g., tramadol), neuropathic pain medications (gabapentin, pregabalin, etc.), or oral corticosteroids within the past 2 weeks;
• Patients who have received non-recommended wrist injection treatments (e.g., 5% glucose, platelet-rich plasma, ozone, chitosan, hyaluronic acid, etc.) within the past 6 months;
• Patients who have undergone non-recommended physical therapies (e.g., electrotherapy, magnetotherapy, laser therapy, etc.) within the past 6 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 3 centers

• Jinjiang Municipal Hospital(Shanghai Sixth People's Hospital Fujian Campus) — Jinjiang
• Yancheng Third People's Hospital — Yancheng
• Shanghai Sixth People's Hospital — Shanghai

Identifiers

NCT: NCT07043179 · 2025-KY-097

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗