Injection versus Decompression for Carpal Tunnel Syndrome-Pilot trial (INDICATE-P)-protocol for a randomised...

Area of Science:

• Orthopedics
• Neurosurgery
• Clinical Trials

Background:

• Carpal tunnel syndrome (CTS) is a prevalent peripheral nerve disorder, with increasing surgical interventions.
• Optimal management for moderate CTS remains debated, balancing early surgery against steroid injection followed by potential later surgery.
• The Injection versus Decompression for Carpal Tunnel Syndrome-Pilot trial (INDICATE-P) addresses this clinical uncertainty.

Purpose of the Study:

• To conduct a feasibility study for a multicenter randomized controlled trial (INDICATE).
• To determine the best treatment approach for adults over 18 with moderate carpal tunnel syndrome.
• To compare early surgical decompression versus a single steroid injection followed by surgery if needed.

Main Methods:

• An open-label, randomized controlled pilot trial design.
• Adult participants with moderate CTS, defined by symptom severity despite splinting, were recruited.
• Participants were randomized to either surgical decompression or a steroid injection, with clinical outcomes assessed at 1, 3, 6, and 12 months.

Main Results:

• Feasibility data on recruitment and retention were collected.
• Patient feedback on questionnaires was gathered to refine study design.
• Suitability of proposed outcome measures for the main INDICATE trial was confirmed.

Conclusions:

• The INDICATE-P study provides crucial data for designing the main INDICATE trial.
• It will aid in assessing the safety and effectiveness of early surgical decompression versus steroid injection for moderate CTS.
• This research aims to guide clinical decision-making for a significant patient population.