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Hydrodissection With Neuroprolotherapy Versus Open Release for Carpal Tunnel Syndrome
Sponsor: Universidade Federal de Pernambuco
Summary
This study is a randomized controlled, parallel-group, non-inferiority trial designed to compare ultrasound-guided hydrodissection combined with neuroprolotherapy versus open carpal tunnel release in patients with carpal tunnel syndrome. Participants will be randomly allocated in a 1:1 ratio using a computer-generated sequence, with allocation concealment ensured by sequentially numbered, sealed, opaque envelopes. Outcome assessment and statistical analysis will be performed by blinded evaluators. The experimental group will undergo a single session of ultrasound-guided hydrodissection with perineural injection of a solution composed of zero point nine percent sodium chloride and five percent dextrose, combined with local anesthetic and betamethasone, aiming to promote mechanical release of the median nerve and modulation of the inflammatory process. The control group will undergo standard open carpal tunnel release through surgical division of the transverse carpal ligament under sterile conditions. Participants will be assessed at baseline, and at 1, 3, and 6 months after intervention. The primary outcome is the change in the Boston Carpal Tunnel Questionnaire score at 3 months. A non-inferiority margin of 0.5 points will be adopted. Secondary outcomes include pain intensity measured by visual analog scale, grip strength, pinch strength, median nerve cross-sectional area assessed by ultrasound, time to return to work, and procedure-related complications. Statistical analysis will follow the intention-to-treat principle, with complementary per-protocol analysis. Between-group comparisons will be conducted using analysis of covariance adjusted for baseline values, and repeated measures will be analyzed using mixed-effects models. The hypothesis is that the minimally invasive intervention is non-inferior to surgical decompression, with potential advantages in recovery and morbidity.
Official title: Ultrasound-Guided Hydrodissection Combined With Neuroprolotherapy Versus Open Carpal Tunnel Release in Patients With Carpal Tunnel Syndrome: A Randomized, Parallel-Group, Non-Inferiority Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2026-05-02
Completion Date
2027-08-31
Last Updated
2026-05-08
Healthy Volunteers
No
Conditions
Interventions
Ultrasound-guided Hydrodissection of the Median Nerve
Ultrasound-guided perineural injection using saline and dextrose solution combined with local anesthetic and betamethasone for mechanical release of the median nerve.
Open Carpal Tunnel Release
Participants will undergo open carpal tunnel release performed under sterile conditions in an operating room, using local or regional anesthesia, through a longitudinal palmar incision with division of the transverse carpal ligament to decompress the median nerve, followed by hemostasis, layered closure, and compressive dressing.
Locations (1)
Hospital das Clínicas da Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil