Nighttime Splinting
DeviceNighttime splinting for 6 weeks.
Other names: Wrist Splint
NCT Number: NCT07042282
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Jinjiang Municipal Hospital(Shanghai Sixth People's Hospital Fujian Campus), Jinjiang, Fujian, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nighttime splinting for 6 weeks.
Other names: 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.
Other names: 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. Throughout the study period, physicians will perform electrophysiological examinations according to changes in patients' clinical status.
Time frame: 0,6 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.
Time frame: 0,6 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.
Time frame: 0,12,18 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 12,18 weeks follow-up.
Time frame: 0,12,18 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 12,18 weeks follow-up.
Time frame: 0,6,12,18 weeks
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.
Time frame: 0,6,12,18 weeks
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.
Time frame: 0,18 weeks
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.
Time frame: 18 weeks
Participants will be asked if they undergo surgery (carpal tunnel decompression) in the last 18 week.
Contact information is provided by the study sponsor or research team.
Yun Qian
Other
Comparison of Initial Treatment for Carpal Tunnel Syndrome Related to Rheumatic Diseases: Corticosteroid Injection Versus Nighttime Splinting - A Pragmatic, Open-Label, Multicenter, Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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