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| Name | Class |
|---|---|
| Shanghai 6th People's Hospital | OTHER |
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The aim of this study is to evaluate the effects of corticosteroid injection verses nighttime splinting as initial treatments on wrist function, quality of life, and sleep quality in patients with rheumatoid disease-related carpal tunnel syndrome. Participants will be randomly assigned to two groups and will receive the following interventions: one group will wear a neutral position night splint for 6 weeks, and the other group will receive a single local injection of methylprednisolone 40 mg as the initial treatment. Follow-up evaluations will be conducted at 6, 12, and 18 weeks to assess wrist function, sleep quality, and quality of life, and to dynamically adjust the treatment plan.
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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. |
|
| Corticosteroid injection | Other | Local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nighttime Splinting | Device | Nighttime splinting for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in BCTQ function status subscale at 6 weeks | 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 weeks follow-up. | 0,6 weeks |
| Change from baseline in BCTQ symptom severity subscale at 6 weeks | 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 weeks follow-up. | 0,6 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 12,18 weeks follow-up. | 0,12,18 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. 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 12,18 weeks follow-up. |
| 0,12,18 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, 18 weeks follow-up. | 0,6,12,18 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 and 18 weeks follow-up. | 0,6,12,18 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 18 weeks follow-up. | 0,18 weeks |
| Surgical rate within 18 weeks | Participants will be asked if they undergo surgery (carpal tunnel decompression) in the last 18 week. | 18 weeks |
| Yancheng Third People's Hospital |
| Yancheng |
| Jiangsu |
| China |
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | China |
|
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D012216 | Rheumatic Diseases |
| 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 |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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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