Hydrodissection With Neuroprolotherapy Versus Open Release for Carpal Tunnel Syndrome

NCT07576803 | Not Yet Recruiting

• 1 other identifier: HN-CTS-01/2026
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome; Median Neuropathy

Keywords

Hydrodissection; Perineural injection; Ultrasound-guided procedure; Carpal Tunnel Syndrome; Median nerve decompression; Minimally invasive treatment; Open carpal tunnel release; Nerve entrapment; Functional outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Hydrodissection + Neuroprolotherapy

EXPERIMENTAL

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

Open Carpal Tunnel Release

ACTIVE COMPARATOR

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

Interventions

Ultrasound-guided Hydrodissection of the Median Nerve PROCEDURE

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

Hydrodissection + Neuroprolotherapy

Open Carpal Tunnel Release PROCEDURE

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.

Open Carpal Tunnel Release

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Hospital das Clínicas da Universidade Federal de Pernambuco

Recife, Pernambuco, 50.670-901, Brazil

Location

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy; Nerve Compression Syndromes

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Giselly V de Miranda, MD

  Hospital das Clínicas - Universidade Federal de Pernambuco (UFPE/EBSERH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giselly V de Miranda, MD

CONTACT

+5581995295894; giselly.miranda@ebserh.gov.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and the statistician will be blinded to group allocation. Participants and treating surgeons cannot be blinded due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants will be allocated in a 1:1 ratio to either ultrasound-guided hydrodissection combined with neuroprolotherapy or open carpal tunnel release, with independent groups and no crossover between interventions.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: May 2, 2026
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)