Comparison of Corticosteroid Injection, Nighttime Splinting, or Their Combination for Initial Treatment of Moderate-to-Severe Carpal Tunnel Syndrome

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYun Qian

About this trial

The goal of this clinical trial is to compare the efficacy of corticosteroid injection, night splinting, and their combined use as initial treatments for adults with moderate to severe carpal tunnel syndrome (CTS), and to assess the safety and tolerability of these interventions. The primary research questions include:

* Doe corticosteroid injection, night splinting, and their combined use as initial treatments reduce the need for surgery in participants with moderate to severe CTS? * How do these interventions affect the improvement of patient symptoms?

Participants will:

* Receive corticosteroid injection, night splinting, or their combination as initial treatments. * Visit the clinic once every 6 weeks over a period of one year for assessments and dynamic adjustment of the treatment plan. * Undergo periodic assessments of wrist function, quality of life, and sleep quality using standardized questionnaires.

Eligibility criteria

Qualifiers

Patients aged no less than 18 years old with idiopathic carpal tunnel syndrome of the target side diagnosed by a specialist according to the Katz diagnostic criteria;

The current episode has occurred within 6 weeks without treatment before eligibility assessment, and the target side has moderate-to-severe symptoms.

Disqualifiers

Patients who have plan for surgical treatment on his or her CTS within the following 6 months;

Any secodary CTS caused by comorbid diseases, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, CPPD (calcium pyrophosphate dihydrate deposition disease), etc.;

History of fracture or surgery on the target side of the wrist;

Bilateral CTS with moderate or severe symptoms in both hands;

Trial design

Treatments tested in this trial

  • Nighttime Splinting
  • Corticosteroid Injection
  • Evaluation and Dynamic Adjustment

Treatment groups

318 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Yun Qian

Lead sponsor

Shanghai 6th People's Hospital

Sponsor institution

Shanghai 6th People's Hospital

Collaborator