Hydrodissection With Neuroprolotherapy Versus Open Release for Carpal Tunnel Syndrome (HN-CTS)

Ultrasound-Guided Hydrodissection Combined With Neuroprolotherapy Versus Open Carpal Tunnel Release in Patients With Carpal Tunnel Syndrome: A Randomized, Parallel-Group, Non-Inferiority Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carpal Tunnel Syndrome; Median Neuropathy
• Intervention / Treatment: Procedure: Ultrasound-guided Hydrodissection of the Median Nerve; Procedure: Open Carpal Tunnel Release

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giselly V de Miranda, MD; Phone Number: +5581995295894; Email: giselly.miranda@ebserh.gov.br

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50.670-901
      • Hospital das Clínicas da Universidade Federal de Pernambuco
      • Contact: Giselly V de Miranda, MD; Phone Number: +5581995295894; Email: giselly.miranda@ebserh.gov.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrodissection + Neuroprolotherapy; 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; Ultrasound-guided perineural injection using saline and dextrose solution combined with local anesthetic and betamethasone for mechanical release of the median nerve.; Other Names: Ultrasound-guided hydrodissection
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 1 month, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Investigators: Principal Investigator: Giselly V de Miranda, MD, Hospital das Clínicas - Universidade Federal de Pernambuco (UFPE/EBSERH)

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2026
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Carpal Tunnel Syndrome; Hydrodissection; Functional outcomes; Ultrasound-guided procedure; Nerve entrapment; Perineural injection; Minimally invasive treatment; Open carpal tunnel release; Median nerve decompression
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Mononeuropathies; Cumulative Trauma Disorders; Sprains and Strains; Nerve Compression Syndromes; Carpal Tunnel Syndrome; Median Neuropathy
• Other Study ID Numbers: HN-CTS-01/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No