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.
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.
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;
Parallel
Nighttime Splinting
DeviceNighttime splinting for 6 weeks.
Corticosteroid Injection
DrugLocal 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.
Evaluation and Dynamic Adjustment
Other intervention6 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.
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.
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.
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.
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.
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Yun Qian
Lead sponsor
Shanghai 6th People's Hospital
Sponsor institution
Shanghai 6th People's Hospital
Collaborator
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