An interventional study of Ultrasound-guided Hydrodissection of the Median Nerve and Open Carpal Tunnel Release in Carpal Tunnel Syndrome and Median Neuropathy, sponsored by Universidade Federal de Pernambuco. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Universidade Federal de Pernambuco · Not applicable, Interventional, and Treatment
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.
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. The study will be conducted at a tertiary referral center. Eligible participants will be adults with a clinical diagnosis of carpal tunnel syndrome who meet predefined inclusion and exclusion criteria.
Participants will be randomly allocated in a 1:1 ratio to either the experimental or control group using a computer-generated randomization sequence. Allocation concealment will be ensured through the use of sequentially numbered, sealed, opaque envelopes prepared by an independent researcher. Outcome assessment and statistical analysis will be performed by blinded evaluators to minimize detection bias.
The experimental group 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. A needle will be positioned 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 approximately ten milliliters. The objective of the intervention is to achieve mechanical separation of the median nerve from surrounding structures and to promote modulation of the local inflammatory environment. The procedure duration is expected to be approximately fifteen to twenty minutes. Post-procedure care will include the use of simple analgesics and guidance for gradual return to daily activities.
The control group will undergo open carpal tunnel release, performed in an operating room under sterile conditions. The procedure will be conducted using local or regional anesthesia and involves a longitudinal palmar incision, identification and division of the transverse carpal ligament to decompress the median nerve, followed by hemostasis, layered closure, and application of a compressive dressing. The procedure duration is expected to be approximately twenty to thirty minutes. Standardized postoperative care will include analgesia, wound care, early finger mobilization, and suture removal between ten and fourteen days.
Participants in both groups will be evaluated at baseline, and at 1, 3, and 6 months after the 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 used to determine whether the experimental intervention is not clinically worse than surgical treatment.
Secondary outcomes will include pain intensity measured by the visual analog scale, grip strength assessed by dynamometry, pinch strength measured using pinch dynamometry, median nerve cross-sectional area assessed by high-resolution ultrasound, time to return to work based on patient self-report, and procedure-related complications recorded during follow-up.
Statistical analysis will be performed according to the intention-to-treat principle, including all randomized participants in the groups to which they were allocated. A per-protocol analysis will also be conducted as a sensitivity analysis. Continuous outcomes will be compared between groups using analysis of covariance models adjusted for baseline values. Longitudinal data across multiple time points will be analyzed using mixed-effects models to account for within-subject correlation over time.
The non-inferiority hypothesis will be tested by comparing the confidence interval of the between-group difference with the predefined non-inferiority margin. If the upper bound of the confidence interval does not exceed the margin of 0.5 points in the Boston Carpal Tunnel Questionnaire score, non-inferiority will be concluded.
This study aims to determine whether a minimally invasive, ultrasound-guided intervention can provide comparable clinical outcomes to open surgical decompression while potentially offering advantages in terms of reduced invasiveness, faster recovery, and lower complication rates.
587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's planned enrollment of 72 is above the median of 60 across 443 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Universidade Federal de Pernambuco is the lead sponsor of 166 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Ultrasound-guided Hydrodissection 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.
Procedure: Open Carpal Tunnel Release
Ultrasound-guided perineural injection using saline and dextrose solution combined with local anesthetic and betamethasone for mechanical release of the median nerve.
Also known as: Ultrasound-guided hydrodissection
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.
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.
Time frame: Baseline to 3 months
Change in pain intensity (Visual Analog Scale)
Pain intensity measured using a visual analog scale ranging from 0 to 10, with higher scores indicating greater pain. Clinically significant improvement defined as a reduction of at least 2 points or 30 percent from baseline.
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in grip strength
Grip strength measured using hand dynamometry. Improvement defined as an increase of at least 20 percent from baseline.
Time frame: Baseline, 1 month, 3 months, and 6 months
Plan to share: No
Start is estimated for May 2026; primary completion for Sep 2026, 4 months later.
Of 251 non-industry interventional studies with no phase under Carpal Tunnel Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 27. This study's planned 4 months is below that.
Counting every sponsor, half of 261 studies reached it within 12 months; a quarter within 7 and three quarters within 26.
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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