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Cancelled by the investigator. Comparison of Corticosteroid Injection, Nighttime Splinting, or Their Combination for Initial Treatment of Moderate-to-Severe Carpal Tunnel Syndrome: A Pragmatic, Three-Armed, Open-Label, Multicenter, Randomized Clinical Trial

Comparison of Corticosteroid Injection, Nighttime Splinting, or Their Combination for Initial Treatment of Moderate-to-Severe Carpal Tunnel Syndrome: A Pragmatic, Three-Armed, Open-Label, Multicenter, Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099581
Enrollment
Unknown
Registered
2025-03-26
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal tunnel syndrome

Interventions

GroupA:Nighttime splinting for 6 weeks
GroupC:Nighttime splinting for 6 weeks,combined with intracarpal tunnel injection of corticosteroids

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1)Patients are 18 years of age or older and have idiopathic carpal tunnel syndrome diagnosed by a specialist physician according to the Katz diagnostic criteria on the target side of the wrist; 2)The current episode has occurred within 6 weeks of enrollment assessment, and the target side of the joint has moderate-to-severe CTS symptoms and has not been treated.

Exclusion criteria

Exclusion criteria: 1) Patients who are scheduled to undergo surgical treatment for CTS within the next 6 months; 2) Any form of CTS that is part of another disease, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, CPPD (calcium pyrophosphate dihydrate deposition disease), etc.; 3) History of fracture or surgery on the target side of the joint; 4) Bilateral CTS with moderate or severe symptoms in both hands; 5) Received corticosteroid injections in the wrist within the past 6 months; 6) Patients who are unable to wear a splint due to trauma or other reasons; 7) 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.; 8) Patients who require long-term use of any form of analgesic medication, such as NSAIDs (nonsteroidal anti-inflammatory drugs), opioids, acetaminophen, etc.; 9) Patients who have used NSAIDs, opioids (e.g., tramadol), neuropathic pain medications (gabapentin, pregabalin, etc.), or oral corticosteroids within the past 2 weeks; 10) 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; 11) Patients who have undergone non-recommended physical therapies (e.g., electrotherapy, magnetotherapy, laser therapy, etc.) within the past 6 months.

Design outcomes

Primary

MeasureTime frame
Surgical rate within 52 weeks;

Secondary

MeasureTime frame
The change in the score of the Boston Carpal Tunnel Questionnaire Symptom Severity subscale (BCTQ symptom severity subscale) from baseline at 52 weeks.;The change in the score of the Boston Carpal Tunnel Questionnaire Symptom Severity subscale (BCTQ symptom severity subscale) from baseline at 6, 12, and 24 weeks.;The change in the score of the Boston Carpal Tunnel Questionnaire Function Status subscale(BCTQ function status subscale)from baseline at 6,12,24,and 52 weeks.;The change in EQ-VAS from baseline at 6, 12, 24, and 52 weeks.;The change in the Pittsburgh Sleep Quality Index(PSQI)from baseline at 6,12,24,and 52 weeks.;

Countries

China

Contacts

Public ContactYun Qian

Shanghai Sixth People's Hospital

sakio@sjtu.edu.cn+86 136 6150 5522

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026