Efficacy of Hyalase Hydrodissection in the Treatment of Carpal Tunnel Syndrome: A Randomized, Double-Blind, Controlled, Clinical Trial.

BACKGROUND: Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, which results from median nerve compression. A lot of nonsurgical modalities are available for the management of mild to moderate situations. Local Hyalase hydrodissection (HD) of the entrapped median nerve could offer a desirable sustained symptom alleviation. OBJECTIVES: To evaluate the clinical efficacy of Hyalase/saline solution carpal tunnel HD on pain, functional status, and nerve conduction in patients with CTS. STUDY DESIGN: A randomized, double-blinded trial. SETTING: Anesthesia, pain, and rheumatology clinics in a university hospital. METHODS: Patients: 60 patients with CTS (> 6 months' duration). INTERVENTION: patients were allocated equally into either group 1 (HD with Hyalase + 10 mL saline solution injection), or group 2 (HD with 10 mL saline solution only). MEASUREMENTS: assessment of pain using Visual Analog Scale (VAS), functional disability (FD) score, and nerve conduction studies before injection, and over 6 months after injection. Nerve conduction parameters before injection and postinjection by the end of 3 and 6 months were evaluated as well. RESULTS: Statistically significant lower postinjection values of VAS (1 +/- 1.8, 2 +/- 1.1, 2 +/- 1.2, 2 +/- 1.1) in group 1 versus (2 +/- 1.2, 3 +/- 1.7, 4 +/- 1.5, 5 +/- 2.6) in group 2 by the end of the first week, and the first, third, and sixth months, and significantly lower FD scores (15.3 +/- 1.2, 13 +/- 1.3, 10.2 +/- 1.3, 10.2 +/- 1.3) in group 1 versus (17.5 +/- 1.8, 16.6 +/- 2.8, 19.4 +/- 3.2, 21.2 +/- 2.5) in group 2 during the same time intervals. Nerve conduction study parameters have shown significantly higher velocity and lower latency in the Hyalase group than in the saline solution group by the 3 and 6 month follow-up. LIMITATION: We suggest a longer period could be reasonable. CONCLUSIONS: Carpal tunnel HD with Hyalase with saline solution is considered as an efficient technique offering a rapid onset of pain relief and functional improvements, and better median nerve conduction in patients with CTS over 6 months follow-up duration. KEY WORDS: Carpal tunnel syndrome, Hyalase, median nerve hydrodissection.