Carpal Tunnel Syndrome (CTS), Rheumatic Diseases
Conditions
Brief summary
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.
Interventions
DEVICENighttime Splinting
Nighttime splinting for 6 weeks.
DRUGCorticosteroid Injection
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.
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.
Sponsors
Shanghai 6th People's Hospital
Yun Qian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged no less than 18 years old with unilateral or bilateral carpal tunnel syndrome diagnosed by a specialist according to the Katz diagnostic criteria, and with at least one associated rheumatic disease; 2. Patients have had symptoms of CTS for at least six weeks, and the side with more severe symptoms is designated as the target side for the study. 3. During the current episode, the target side has not been treated.
Exclusion criteria
1. Patients who have plan for surgical treatment on his or her CTS within the following 6 months; 2. Received corticosteroid injections in the wrist within the past 6 months; 3. Patients who are unable to wear a splint due to trauma or other reasons; 4. Patients with clinical manifestations or electrophysiological changes indicative of significant axonal loss or denervation, including thenar muscle atrophy, sensory loss (two-point discrimination greater than 8 mm), absence of SNAP (sensory nerve action potential), absence of CMAP (compound muscle action potential) in the thenar muscles, etc.; 5. Patients who require long-term use of any form of opioids. 6. Patients who have used opioids (e.g., tramadol) or neuropathic pain medications (gabapentin, pregabalin, etc.) within the past 2 weeks; 7. Patients who have received non-recommended wrist injection treatments (e.g., 5% glucose, platelet-rich plasma, ozone, chitosan, hyaluronic acid, etc.) within the past 6 months; 8. Patients who have undergone non-recommended physical therapies (e.g., electrotherapy, magnetotherapy, laser therapy, etc.) within the past 6 months; 9. Patients who are pregnant or plan to become pregnant within the next 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in BCTQ function status subscale at 6 weeks | 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. |
| Change from baseline in BCTQ symptom severity subscale at 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in BCTQ function status subscale | 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. |
| Change from baseline of EQ-VAS | 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. |
| Surgical rate within 18 weeks | 18 weeks | Participants will be asked if they undergo surgery (carpal tunnel decompression) in the last 18 week. |
| Change from baseline of the cross-sectional area of the median nerve | 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. |
| Change from baseline of PSQI | 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. |
| Change from baseline in BCTQ symptom severity subscale | 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. |
Countries
China
Contacts
Primary ContactJiaqi Su
Backup ContactYun Qian
Outcome results
None listed