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Ultrasound-Guided Hydrodissection Combined With Neuroprolotherapy Versus Open Carpal Tunnel Release in Patients With Carpal Tunnel Syndrome: A Randomized, Parallel-Group, Non-Inferiority Trial
Sponsor study identifier
interventional
72
1 country
1
Study Start
May 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 4, 2026
Actual (reported)May 8, 2026
Actual (reported)September 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Boston Carpal Tunnel Questionnaire score
Change from baseline in the Boston Carpal Tunnel Questionnaire total score at 3 months. The primary analysis will assess the between-group difference using a non-inferiority framework with a predefined margin of 0.5 points. Lower scores indicate better outcomes.
Baseline to 3 months
Change in pain intensity (Visual Analog Scale)
Baseline, 1 month, 3 months, and 6 months
Change in grip strength
Baseline, 1 month, 3 months, and 6 months
Participants will undergo a single session of ultrasound-guided hydrodissection combined with neuroprolotherapy. The procedure will be performed under sterile conditions with real-time ultrasound guidance, with needle placement adjacent to the median nerve at the level of the carpal tunnel, followed by perineural injection of a solution composed of zero point nine percent sodium chloride and five percent dextrose, combined with local anesthetic and betamethasone, with a total volume of ten milliliters, aiming to achieve mechanical nerve release and inflammatory modulation.
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.
Ultrasound-guided perineural injection using saline and dextrose solution combined with local anesthetic and betamethasone for mechanical release of the median nerve.
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.
Hospital das Clínicas da Universidade Federal de Pernambuco
Recife, Pernambuco, 50.670-901, Brazil
Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.
Padua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, Caliandro P, Hobson-Webb LD. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-1284. doi: 10.1016/S1474-4422(16)30231-9. Epub 2016 Oct 11.
Giselly V de Miranda, MD
Hospital das Clínicas - Universidade Federal de Pernambuco (UFPE/EBSERH)
First Submitted
May 4, 2026
First Posted
May 8, 2026
Study Start
May 2, 2026
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Keith MW, Masear V, Chung K, Maupin K, Andary M, Amadio PC, Barth RW, Watters WC 3rd, Goldberg MJ, Haralson RH 3rd, Turkelson CM, Wies JL. Diagnosis of carpal tunnel syndrome. J Am Acad Orthop Surg. 2009 Jun;17(6):389-96. doi: 10.5435/00124635-200906000-00007.
Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 8, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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