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| Name | Class |
|---|---|
| Shanghai 6th People's Hospital | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nighttime splinting | Other | Wear a wrist neutral position splint at night for 6 weeks as the initial treatment. |
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| Corticosteroid injection | Other | Local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment. |
|
| Combination | Other | Nighttime splinting for 6 weeks combined with local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nighttime Splinting | Device | Nighttime splinting for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical rate within 52 weeks | Participants will be asked if they have undergone surgery for carpal tunnel syndrome in the last 52 weeks. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0,6,12,24,52 weeks |
| Change from baseline in BCTQ function status subscale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaqi Su | Contact | 86 21 64369181 | sjqjswy@foxmail.com | |
| Yun Qian | Contact | 86 21 64369181 | sakio@sjtu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinjiang Municipal Hospital(Shanghai Sixth People's Hospital Fujian Campus) | Jinjiang | Fujian | China | |||
Upon completion of the study for publication, by reasonable request via email to the corresponding author.
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| Corticosteroid Injection | Drug | 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. |
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| Evaluation and Dynamic Adjustment | Other | 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. |
|
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. |
| 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. | 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. | 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. | 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. | 52 weeks |
| Yancheng Third People's Hospital |
| Yancheng |
| Jiangsu |
| China |
| Shanghai Sixth People's Hospital | Shanghai | 200233 | China |
|
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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