Clinical Research Directory

Prior to treatment, blinding will be ensured through the use of eye masks. Based on the "affected muscle theory," all forearm muscles within the splint-immobilized area will be considered as an affected muscle group and further subdivided into "flexor" and "extensor" subgroups according to functional anatomy. Two needle insertion points will be selected approximately 5 cm distal to the cubital crease, corresponding to the flexor and extensor muscle groups. Following standard disinfection of the insertion device and sites, a disposable FSN needle will be inserted subcutaneously into the superficial fascial layer, with the needle tip directed toward the affected muscle group. The needle core will then be retracted into the soft tube, ensuring no tip exposure, and the tube base will be secured within the handle slot. A 30° fan-shaped sweeping motion will be performed bilaterally at a frequency of 100 sweeps/min for 2 minutes.

Patients randomized to this group will undergo the sham intervention in the same predetermined anatomical region. Prior to the procedure, eye masks will be applied to ensure blinding. The Sham FSN device, featuring a blunt tip, will generate a pricking sensation upon spring-loaded actuator deployment without actual skin penetration, maintaining parallel alignment to the epidermal surface. Following standard aseptic preparation, the acupuncturist will stabilize the needle body with the non-dominant hand while simulating insertion motions with the dominant hand, replicating the authentic FSN technique by retracting the stylet to the locking groove. The practitioner will then perform sweeping manipulations (ensuring continuous dermal contact during the procedure). Both the operational protocol and treatment course will be identical to those of the genuine FSN intervention group.