Round-Sharp Needle for Limb Spasms After a Stroke: Study Protocol for a Randomized Controlled Trial.

Area of Science:

• Neurology
• Rehabilitation Medicine
• Traditional Chinese Medicine

Background:

• Stroke is a leading cause of limb spasticity, impacting patient mobility and quality of life.
• Acupuncture is a recognized treatment for post-stroke spasticity.
• Round-sharp needles may offer advantages over traditional filiform needles in treatment duration and efficiency, but require further clinical validation.

Purpose of the Study:

• To investigate the short-term efficacy and safety of round-sharp needle therapy for post-stroke limb spasticity.
• To compare the effects of round-sharp needles with traditional filiform needles in treating this condition.
• To gather preliminary data supporting the wider clinical application of round-sharp needle therapy.

Main Methods:

• A randomized, single-blind, prospective, single-center pilot clinical trial.
• Participants will be randomized into either a round-sharp needle group (3 times/week) or a filiform needle group (5 times/week).
• Treatment duration is two weeks, with assessments including surface electromyography (sEMG), Modified Ashworth Scale (MAS), Fugl-Meyer Assessment (FMA), Modified Barthel Index (MBI), and safety evaluations.

Main Results:

• This section is to be populated upon study completion.

Conclusions:

• The trial aims to provide evidence on the safety and efficacy of round-sharp needles for post-stroke limb spasticity.
• Findings are expected to guide future clinical practice and research in acupuncture for stroke rehabilitation.