AzTrials
AzTrials

Carpal Tunnel Syndrome (CTS)Early Phase 1NCT07825155

Ultrasound-Guided Injection of Carpal Tunnel Syndrome Using Hyaluronic Acid vs Corticosteroid vs Glucose 5%

A Early Phase 1 study testing Hyaluronic Acid- corticosteroid- 5% glucose in people with Carpal Tunnel Syndrome (CTS), run by Tanta University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Carpal Tunnel Syndrome (CTS)
What is being tested?
Hyaluronic Acid- corticosteroid- 5% glucose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
15 Mar 2026to 30 Oct 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • -

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nahla ME Mahfouz, Batcholer degree of medicine a contact

+201279151365

dr.nahlamahfouz@gmail.com

Egypt1 site, 1 recruiting
  • Tanta University Faculty of Medicine

    Tanta, Gharbia Governorate, 31527

    Nahla ME Mahfouz, Bachelor degree of medicine, dr.nahlamahfouz@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Ultrasound-Guided Injection of Mild to Moderate Carpal Tunnel Syndrome Using Hyaluronic Acid vs Corticosteroid vs 5% Glucose: Comparative Study

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.

Read the detailed description

Detailed Description

Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment syndrome and results from compression of the median nerve as it passes through the carpal tunnel at the wrist. The carpal tunnel is a relatively narrow osteofibrous canal containing the median nerve and nine flexor tendons. Any condition that decreases the available space within the tunnel or increases the volume of its contents may increase intracarpal pressure and compromise median nerve function.

The clinical severity of CTS can range from mild to severe. Mild CTS is generally characterized by intermittent sensory symptoms and sensory conduction abnormalities, whereas moderate CTS may involve both sensory and motor nerve conduction abnormalities. Severe disease may be associated with persistent numbness, weakness, thenar muscle atrophy, and evidence of more advanced nerve damage. The present study will focus on patients with mild to moderate CTS, confirmed clinically and electrophysiologically.

Conservative management of CTS includes wrist splinting, physiotherapy, and local injections. Corticosteroid injection is an established treatment option that can provide short-term symptomatic relief. More recently, other injectates have been investigated. Hyaluronic acid (HA) has been proposed as a treatment that may reduce perineural adhesions and improve median nerve gliding. In addition, perineural injection and hydrodissection using 5% glucose (D5W) have shown promising results in patients with neuropathic pain conditions, including CTS.

Ultrasound guidance will be used for all injections. Ultrasound guidance allows visualization of the median nerve and surrounding anatomical structures during the procedure and facilitates accurate placement of the injectate while avoiding direct injury to the median nerve. Ultrasonography will also be used to measure the median nerve cross-sectional area (CSA), providing an objective structural parameter for assessment and follow-up.

Study Objective

The primary objective of this comparative study is to evaluate and compare the efficacy of ultrasound-guided injections of hyaluronic acid, corticosteroid, and 5% glucose in patients with mild to moderate CTS. Treatment response will be evaluated using clinical, electrophysiological, and ultrasonographic findings.

Study Population and Design

The study will be conducted in the Department of Rheumatology, Rehabilitation, and Physical Medicine at Tanta University Hospitals. A total of 60 adult patients with mild to moderate CTS will be included. Participants will be divided into three treatment groups, with 20 patients in each group.

Eligible participants will be adults aged 18-70 years with clinical symptoms of CTS lasting at least 6 weeks and electrophysiological confirmation of mild to moderate CTS. All participants must be able to provide informed consent.

Patients will be excluded if they have received an injection into the same wrist within the previous 6 months, have undergone previous carpal tunnel surgery, have severe CTS characterized by absent sensory potentials or electromyographic evidence of denervation, or have local infection or coagulopathy.

Baseline Assessment

Before treatment, all participants will undergo a baseline assessment. This will include a full medical history and comprehensive neurological and musculoskeletal examination of the wrist.

Clinical assessment will include:

Phalen's test. Tinel's sign.

Electrophysiological assessment will be performed using nerve conduction studies (NCS), including:

Median sensory distal amplitude and conduction velocity. Median motor distal latency and amplitude. Maintenance of limb temperature at or above 32°C during the examination.

Ultrasound examination will be performed to determine the cross-sectional area of the median nerve using tracing of the inner hyperechoic rim of the epineurium.

Intervention Procedures

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. The injection will be administered into the carpal tunnel under ultrasound guidance.

Group 3 - 5% Glucose

Participants in the 5% glucose group will receive 5 mL of 5% glucose (D5W) by ultrasound-guided hydrodissection around the median nerve. The procedure will aim to separate the median nerve from the flexor retinaculum and surrounding tissues.

Follow-Up and Outcome Assessment

Participants will be reassessed 3 months after the injection. Follow-up assessment will include repetition of the clinical, electrophysiological, and ultrasonographic evaluations.

Clinical outcomes will be assessed using Phalen's test and Tinel's sign. Electrophysiological outcomes will be evaluated using nerve conduction studies, including the relevant median sensory and motor nerve conduction parameters. Ultrasonographic follow-up will include reassessment of the median nerve cross-sectional area.

The study will compare the findings obtained after treatment among the three intervention groups to assess differences in treatment response.

Study Duration

The study is planned to continue for at least 12 months, from January 2026 to December 2026.

Potential Benefits

The study is intended to provide comparative information regarding three non-surgical injection approaches for the management of mild to moderate CTS. The findings may help in evaluating the relative clinical, electrophysiological, and ultrasonographic responses associated with hyaluronic acid, corticosteroid, and 5% glucose injections.

Potential Risks

The protocol identifies infection as a potential risk associated with injection procedures. Sterile equipment and sterile technique will be used to minimize this risk. Any unexpected risk that becomes apparent during the study will be communicated promptly to the participant and the relevant ethical committee.

Ethical Considerations

Informed consent will be obtained from all participants before their inclusion in the study. Participant privacy and confidentiality will be maintained. Patient names will be removed from electrophysiological and ultrasound reports to protect participant identity. Any unexpected risks arising during the course of the research will be promptly communicated to the participant and the ethical committee.

The results of the study will be tabulated and statistically analyzed, and the findings will subsequently be discussed in relation to available published data.

Being tested
Hyaluronic Acid- corticosteroid- 5% glucose
Keywords
Carpal Tunnel Syndrome; Mild to Moderate CTS; Ultrasound-Guided Injection; Hyaluronic Acid; Corticosteroid; 5% Glucose; Hydrodissection; NCS
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyaluronic Acid- corticosteroid- 5% glucoseDrug

    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.

Study groups in NCT07825155
Study groupRoleWhat they receive
Hyaluronic AcidExperimentalParticipants 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.
Receives: Drug: Hyaluronic Acid- corticosteroid- 5% glucose
CorticosteroidExperimentalParticipants 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.
Receives: Drug: Hyaluronic Acid- corticosteroid- 5% glucose
5% GlucoseExperimentalParticipants 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.
Receives: Drug: Hyaluronic Acid- corticosteroid- 5% glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 3 months after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study start15 Mar 2026
  3. Primary completion20 Jun 2026
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07825155
Sponsor's protocol ID
36264MS101090/12/25
Status last verified
Jan 2026
First submitted
13 Sep 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Hyaluronic Acid- corticosteroid- 5% glucose in people with Carpal Tunnel Syndrome (CTS), run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nahla ME Mahfouz, Batcholer degree of medicine a (+201279151365, dr.nahlamahfouz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in median nerve cross-sectional area (CSA) (time frame: Baseline to 3 months after injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07825155, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in