An interventional study of Nighttime Splinting and Corticosteroid Injection in Carpal Tunnel Syndrome (CTS), sponsored by Yun Qian. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by Yun Qian · Not applicable, Interventional, and Treatment
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:
Participants will:
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 140 are open to participants now.
This study's planned enrollment of 318 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Yun Qian is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Wear a wrist neutral position splint at night for 6 weeks as the initial treatment.
Device: Nighttime Splinting · Other: Evaluation and Dynamic Adjustment
Local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment.
Drug: Corticosteroid Injection · Other: Evaluation and Dynamic Adjustment
Nighttime splinting for 6 weeks combined with local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment.
Device: Nighttime Splinting · Drug: Corticosteroid Injection · Other: Evaluation and Dynamic Adjustment
Nighttime splinting for 6 weeks.
Also known as: Wrist Splint
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 paresthesia (which usually indicates nerve irritation), the injection site should be adjusted.
Also known as: Steroid Injection
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 weeks, with dynamic adjustments to the treatment plan. Corticosteroid injections will be administered at least 24 weeks apart, and the second injection dosage may be adjusted based on the patient's condition, with a maximum dose of 80mg. Throughout the study period, physicians will perform electrophysiological examinations according to changes in patients' clinical status.
Surgical rate within 52 weeks
Participants will be asked if they have undergone surgery for carpal tunnel syndrome in the last 52 weeks.
Time frame: 52 weeks
Change from baseline in BCTQ symptom severity subscale
Change from baseline in the score of the BCTQ symptom severity subscale (Boston Carpal Tunnel Questionnaire Symptom Severity subscale) will be compared between treatment groups at 6 ,12, 24 and 52 weeks follow-up.
Time frame: 0,6,12,24,52 weeks
Change from baseline in BCTQ function status subscale
Change from baseline in the score of the BCTQ function status subscale (Boston Carpal Tunnel Questionnaire Function Status Subscale) will be compared between treatment groups at 6 ,12, 24 and 52 weeks follow-up.
Time frame: 0,6,12,24,52 weeks
Change from baseline of EQ-VAS
The EQ-VAS is a measure of the overall health of respondents on the day of the survey. Change from baseline in the score of EQ-VAS will be compared between treatment groups at 6 ,12, 24 and 52 weeks follow-up.
Time frame: 0,6,12,24,52 weeks
Change from baseline of PSQI
The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality. Change from baseline in the score of the PSQI will be compared between treatment groups at 6 ,12, 24 and 52 weeks follow-up.
Time frame: 0,6,12,24,52 weeks
Change from baseline of the cross-sectional area of the median nerve
The median nerve cross-sectional area will be measured with musculoskeletal ultrasound. Change from baseline of the cross-sectional area will be compared at 52 weeks follow-up.
Time frame: 0,52 weeks
The incidence rate of clinical and electrophysiological changes indicative of new-onset axonal loss or denervation within 52 weeks
Researchers will assess and record whether there are any new clinical or electrophysiological changes indicating axonal loss or denervation during follow-up. The incidence rates of these changes in different treatment groups will be compared at the 52-week follow-up.
Time frame: 52 weeks
Plan to share: Yes — Upon completion of the study for publication, by reasonable request via email to the corresponding author.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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