NCT07825155

Brief Summary

Carpal tunnel syndrome (CTS) is a common peripheral nerve entrapment disorder caused by compression of the median nerve at the wrist. This study is a comparative study designed to evaluate the efficacy of three ultrasound-guided injection treatments for patients with mild to moderate CTS: hyaluronic acid (HA), corticosteroid, and 5% glucose (D5W). A total of 60 adult patients with clinically and electrophysiologically confirmed mild to moderate CTS will be enrolled and divided into three groups of 20 patients each. Participants will receive a single ultrasound-guided injection using one of the three study interventions. Clinical assessment will include Phalen's test and Tinel's sign. Electrophysiological assessment will include median nerve sensory and motor nerve conduction parameters, while ultrasonographic assessment will include measurement of the median nerve cross-sectional area. Participants will be reassessed three months after the intervention using the same clinical, electrophysiological, and ultrasonographic measures. The study will compare changes in these outcomes among the three treatment groups to evaluate their relative efficacy in the management of mild to moderate CTS.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
1mo left

Started Mar 2026

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Mar 2026Oct 2026

Study Start

First participant enrolled

March 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Expected
Last Updated

September 23, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

September 13, 2026

Last Update Submit

September 19, 2026

Conditions

Keywords

Carpal Tunnel Syndrome; Mild to Moderate CTS; Ultrasound-Guided Injection; Hyaluronic Acid; Corticosteroid; 5% Glucose; Hydrodissection; NCS

Outcome Measures

Primary Outcomes (1)

  • Change in median nerve cross-sectional area (CSA)

    Median nerve cross-sectional area measured by ultrasound at baseline and 3 months after treatment, comparing the change among the three treatment groups.

    Baseline to 3 months after injection

Study Arms (3)

Hyaluronic Acid

EXPERIMENTAL

Participants will receive 2-3 mL of high-molecular-weight hyaluronic acid by ultrasound-guided perineural injection around the median nerve. The injection will be performed under sterile conditions. Participants will be positioned either supine or seated with the forearm supinated. The ultrasound probe will be positioned transversely over the inlet of the carpal tunnel, and an in-plane ulnar approach will be used. Care will be taken to avoid piercing the median nerve.

Drug: Hyaluronic Acid- corticosteroid- 5% glucose

Corticosteroid

EXPERIMENTAL

Participants will receive triamcinolone acetonide 40 mg mixed with 1 mL of lidocaine by ultrasound-guided injection into the carpal tunnel. The injection will be performed under sterile conditions. Participants will be positioned either supine or seated with the forearm supinated. The ultrasound probe will be positioned transversely over the inlet of the carpal tunnel, and an in-plane ulnar approach will be used. Care will be taken to avoid piercing the median nerve.

Drug: Hyaluronic Acid- corticosteroid- 5% glucose

5% Glucose

EXPERIMENTAL

Participants will receive 5 mL of 5% glucose (D5W) by ultrasound-guided hydrodissection around the median nerve. The injection will be performed under sterile conditions. Participants will be positioned either supine or seated with the forearm supinated. The ultrasound probe will be positioned transversely over the inlet of the carpal tunnel, and an in-plane ulnar approach will be used. Care will be taken to avoid piercing the median nerve.

Drug: Hyaluronic Acid- corticosteroid- 5% glucose

Interventions

All injections will be performed under sterile conditions with ultrasound guidance. The participant will be positioned either supine or seated with the forearm supinated. The ultrasound probe will be positioned transversely over the inlet of the carpal tunnel, and an in-plane ulnar approach will be used. Particular care will be taken to avoid piercing the median nerve. Participants will receive one of the following ultrasound-guided injection interventions: Group 1 - Hyaluronic Acid Participants in the HA group will receive 2-3 mL of high-molecular-weight hyaluronic acid. The HA will be injected perineurally with the intention of creating a gliding plane around the median nerve and reducing perineural adhesions. Group 2 - Corticosteroid Participants in the corticosteroid group will receive triamcinolone acetonide 40 mg mixed with 1 mL of lidocaine.

5% GlucoseCorticosteroidHyaluronic Acid

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-70 years. Clinical symptoms of carpal tunnel syndrome for ≥6 weeks. Electrophysiological confirmation of mild to moderate carpal tunnel syndrome. Ability to provide informed consent.

You may not qualify if:

  • Prior injection into the same wrist within the previous 6 months. Previous carpal tunnel surgery. Severe carpal tunnel syndrome, defined by absent sensory potentials or electromyographic evidence of denervation.
  • Local infection or coagulopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Faculty of Medicine

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

Related Publications (1)

  • 1- Klauser AS, Halpern EJ, De Zordo T, et al. Carpal tunnel syndrome assessment with US: value of additional cross-sectional area measurements of the median nerve in patients versus healthy volunteers. Radiology. 2009;250(1):171-177250 (1): 171-177 2- Padua L, Coraci D, Erra C, et al. Carpal tunnel syndrome: clinical features, diagnosis, and management. The Lancet Neurology. 2016;15(12):1273-1284;15 (12): 1273-1284 3- Atroshi I, Gummesson C, Johnsson R, et al. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999;282(2):153-158;282 (1): 153-158 4- Wang H, Zhu Y, Wei H, rt al. Ultrasound guided local corticosteroid injection for carpal tunnel syndrome: a meta analysis of randomized controlled trials. Clin Rehabil. 2021;35(11):1506-1517 5- Raeissadat SA, Shakoori M, Cheraghi M., et al. High molecular weight hyaluronic acid for CTS: randomized controlled trial. 2025; 12(3): e149480 6- Babaei-Ghazani A, Moradnia S., Azar M., et al. 5% dextrose versus corticosteroid injection in CTS: RCT. Pain Manag. 2022; 12(6): 687-697 7- Kwon HK, Kim J, Lee J, et al. Ultrasonography of the median nerve and electrophysiologic severity in carpal tunnel syndrome. Ann Rehabil Med. 2012;36(1):72-79 8- Ramadan M, Hussein W, Salem M, et al. Conventional ultrasound and shear wave elastography in diagnosing and differentiating the severity of carpal tunnel syndrome: correlation with electrodiagnostic studies. Egypt J Radiol Nucl Med. 2024;55(1):47-55. 9- Su, Y. C., Shen, Y. P., Li, T. Y., et al. The efficacy of hyaluronic acid for carpal tunnel syndrome: A randomized, double-blind, placebo-controlled trial. Pain Medicine, 2021; 22(6), pp. 1384-1393. 10- Chappell CD, Beckman JP, Baird BC, et al. Ultrasound (US) Changes in the Median Nerve Cross-Sectional Area After Microinvasive US Guided Carpal Tunnel Release. J Ultrasound Med. 2020 Apr;39(4):693 702

    RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Glucose

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Central Study Contacts

Nahla ME Mahfouz, Batcholer degree of medicine a

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned to one of three parallel treatment groups and will receive a single ultrasound-guided injection of hyaluronic acid, corticosteroid, or 5% glucose for the treatment of mild to moderate carpal tunnel syndrome. Clinical, electrophysiological, and ultrasonographic outcomes will be assessed at baseline and at 3 months after treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DOCTOR

Study Record Dates

First Submitted

September 13, 2026

First Posted

September 17, 2026

Study Start

March 15, 2026

Primary Completion

June 20, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

September 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations