Not yet recruiting NCT07576803

Hydrodissection With Neuroprolotherapy Versus Open Release for Carpal Tunnel Syndrome

No phase Interventional Carpal Tunnel Syndrome Median Neuropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Ultrasound-guided Hydrodissection of the Median Nerve, Open Carpal Tunnel Release.
Who it may be relevant to: Registry conditions: Carpal Tunnel Syndrome, Median Neuropathy. Basic parameters: 18 years — 70 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Brazil
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Detailed description

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.

Interventions

Procedure 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.
Procedure 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.

Primary outcome measures

Change in Boston Carpal Tunnel Questionnaire score [Time frame: Baseline to 3 months]

Secondary outcome measures (2)

Change in pain intensity (Visual Analog Scale) [Time frame: Baseline, 1 month, 3 months, and 6 months]
Change in grip strength [Time frame: Baseline, 1 month, 3 months, and 6 months]

Eligibility criteria

Inclusion criteria

Adults aged 18 years or olde
Clinical diagnosis of carpal tunnel syndrome
Presence of symptoms for at least 3 months
Failure of conservative treatment, including splinting, medication, or physical therapy
Ability to provide informed consent

Exclusion criteria

Previous carpal tunnel surgery in the affected limb
Severe thenar muscle atrophy
Cervical radiculopathy or proximal nerve compression
Pregnancy
Coagulopathy or current use of anticoagulants contraindicating procedures
Local infection at the intervention site
Inability to comply with follow-up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Treatment

Study locations

Brazil · 1 center

Hospital das Clínicas da Universidade Federal de Pernambuco — Recife

Publications

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. PMID 28778254
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. PMID 27751557
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. PMID 19474448
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. PMID 8245050

Identifiers

NCT: NCT07576803 · HN-CTS-01/2026

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗