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Cancelled by the investigator. 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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099604
Enrollment
Unknown
Registered
2025-03-26
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

carpal tunnel syndrome

Interventions

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 been diagnosed with unilateral or bilateral carpal tunnel syndrome (CTS) by a specialist physician according to the Katz diagnostic criteria, and have at least one associated rheumatic disease. 2. The patient's CTS symptoms have persisted for more than 6 weeks, and the side with more severe current symptoms is designated as the target side for the study. 3. The target side of the CTS episode has not been previously treated.

Exclusion criteria

Exclusion criteria: 1) Patients who are planned to undergo surgical treatment for CTS within the next 6 months; 2) Patients who have 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 severe 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 thenar muscle CMAP (Compound Muscle Action Potential), etc. 5) Patients who require long-term use of any form of opioid medication; 6) Patients who have used opioid medications (e.g., tramadol) or neuropathic pain relief medications (e.g., gabapentin, pregabalin) within the past 2 weeks; 7) Patients who have received non-recommended wrist injection treatments within the past 6 months (e.g., 5% glucose, platelet-rich plasma, ozone, chitosan, hyaluronic acid, etc.); 8) Patients who have undergone non-recommended physical therapies within the past 6 months (e.g., electrotherapy, magnetotherapy, laser therapy, etc.); 9) Patients who are pregnant or plan to become pregnant within the next 6 months.

Design outcomes

Primary

MeasureTime frame
The severity of carpal tunnel syndrome symptoms;

Secondary

MeasureTime frame
pain;Sleep Quality;The cross-sectional area of the median nerve ;Surgical rate within 18 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