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Carpal Tunnel Syndrome (CTS)Phase 3NCT07474714

Hyaluronic Acid Injection in Idiopathic Carpal Tunnel Syndrome; is it Effective as Local Corticosteroids

A Phase 3 study testing Low Molecular Weight Hyaluronic Acid and corticosteroid in people with Carpal Tunnel Syndrome (CTS), run by Minia University Hospital at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study compares the effectiveness of two types of local injections-Hyaluronic Acid (HA) and corticosteroids-for treating mild to moderate idiopathic Carpal Tunnel Syndrome (CTS). Sixty adult patients will be assigned to receive one of the two injections under ultrasound guidance. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carpal Tunnel Syndrome (CTS)
What is being tested?
Low Molecular Weight Hyaluronic Acid and corticosteroid
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
Feb 2026to Sep 2026
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Numbness or pain in the Median Nerve (MN) distribution.
  • Nerve conduction studies (NCS) consistent with CTS as per the AANEM guidelines.
  • An MN cross-sectional area (CSA) at the wrist >12 mm²

Who cannot join

  • Patients with severe symptoms (indication for surgery).
  • Patients who show improvement on medical treatment.
  • Patients with previous surgical or injectional CTS treatment.
  • Coexistence of brachial plexopathy, or thoracic outlet syndrome.
  • Patients with infection at the site of injection.

Trial locations and contacts

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

Yara Assem Assem, MD contact

+201093383306

yara.asem@mu.edu.eg

Haidy Mohamed Osman, Osman contact

+201097238632

haidy.muhamad@mu.edu.eg

Egypt1 site

  • Minia University Hosopital

    Minya, 61111

    Facility of Medicine Minia University, +20862342584, dean.med@mu.edu.eg

    Yara Assem, MD

Other trials in Egypt

About this study

Official title: Hyaluronic Acid Injection in Idiopathic Carpal Tunnel Syndrome; is it Effective as Local Corticosteroids? A Comparative Follow up Study

This study compares the effectiveness of two types of local injections-Hyaluronic Acid (HA) and corticosteroids-for treating mild to moderate idiopathic Carpal Tunnel Syndrome (CTS). Sixty adult patients will be assigned to receive one of the two injections under ultrasound guidance. The goal is to see if HA is as effective as the standard corticosteroid treatment in improving symptoms and nerve function over a 3-month follow-up period.

Read the detailed description

This is a prospective comparative 3-month follow-up study. Sixty adult patients diagnosed with mild or moderate idiopathic CTS by electro-diagnostic studies will be recruited from the Rheumatology and rehabilitation clinic at Minia University Hospitals, Egypt. Participants will be divided into two groups of 30: one receiving low molecular weight hyaluronic acid and the other receiving corticosteroids, both administered via ultrasound-guided perineural injection. Baseline and follow-up assessments at 1- and 3-months post-injection will include the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) scores, electro-diagnostic parameters (sensory and motor latencies, CMAP, etc.), and neuromuscular ultrasound examination (median nerve cross-sectional area, flattening ratio, etc.).

Being tested
Low Molecular Weight Hyaluronic Acid, corticosteroid
Keywords
Carpal Tunnel Syndrome (CTS), Hyaluronic Acid, Corticosteroid Injection, Ultrasound-Guided Injection, Median Nerve
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.

  • Low Molecular Weight Hyaluronic AcidDrug

    Ultrasound-guided perineural injection of low molecular weight Hyaluronic Acid.

  • corticosteroidDrug

    Ultrasound-guided perineural injection of corticosteroids

Study groups in NCT07474714
Study groupRoleWhat they receive
Hyaluronic Acid GroupExperimentalArm Description 30 adult patients with mild to moderate idiopathic CTS receiving ultrasound-guided perineural injection of low molecular weight Hyaluronic Acid.
Receives: Drug: Low Molecular Weight Hyaluronic Acid
Corticosteroid GroupActive comparatorArm Description 30 adult patients with mild to moderate idiopathic CTS receiving ultrasound-guided perineural injection of corticosteroids.
Receives: Drug: corticosteroid

What is being measured

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

  1. Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Scores

    Comparison of the BCTQ scores (symptom severity and functional status) between the Hyaluronic Acid and Corticosteroid groups.

    Measured: Baseline, 1 month, and 3 months post-injection

  2. Change in Electro-diagnostic Parameters

    Comparison of sensory and motor electrodiagnostic parameters between the two groups, including peak sensory latency (ms), sensory nerve action potential - SNAP (µV), sensory conduction velocity - SCV (m/s), distal motor latency (ms), compound muscle action potential - CMAP (mV), and motor conduction velocity - MCV (m/s).

    Measured: Time Frame Baseline, 1 month, and 3 months post-injection

  3. Change in Neuromuscular Ultrasound Examination Parameters

    Comparison of neuromuscular ultrasound parameters between the two groups, including the median nerve cross-sectional area (CSA) measured in mm², fascicular pattern, flattening ratio, and mobility of the median nerve.

    Measured: Baseline, 1 month, and 3 months post-injection

Timeline

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

  1. First posted16 Mar 2026
  2. Study startFeb 2026 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionSep 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
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07474714
Sponsor's protocol ID
1875/02/2026
Status last verified
Mar 2026
First submitted
9 Mar 2026
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Senna MK, Shaat RM, Ali AAA. Platelet-rich plasma in treatment of patients with idiopathic carpal tunnel syndrome. Clin Rheumatol. 2019 Dec;38(12):3643-3654. doi: 10.1007/s10067-019-04719-7. Epub 2019 Aug 16.

    PubMed 31420812

  • Jiang J, Xing F, Luo R, Liu M. Effectiveness of Platelet-Rich Plasma for Patients With Carpal Tunnel Syndrome: A Systematic Review and meta-Analysis of Current Evidence in Randomized Controlled Trials. Front Pharmacol. 2022 Apr 27;13:834213. doi: 10.3389/fphar.2022.834213. eCollection 2022.

    PubMed 35571114

  • Malahias MA, Nikolaou VS, Johnson EO, Kaseta MK, Kazas ST, Babis GC. Platelet-rich plasma ultrasound-guided injection in the treatment of carpal tunnel syndrome: A placebo-controlled clinical study. J Tissue Eng Regen Med. 2018 Mar;12(3):e1480-e1488. doi: 10.1002/term.2566. Epub 2017 Dec 17.

    PubMed 28873284

  • Cansever U, Koldas Dogan S, Erdem Toslak I, Bilgilisoy Filiz M, Toraman NF. Comparison of the effectiveness of platelet-rich plasma (PRP) injection and steroid injection in patients with bilateral moderate carpal tunnel syndrome: a prospective randomized controlled trial. Injury. 2026 Mar;57(3):113018. doi: 10.1016/j.injury.2026.113018. Epub 2026 Jan 9.

    PubMed 41548406

  • Hong P, Zheng Y, Rai S, Ding Y, Zhou Y, Liu R, Li J. Efficacy and safety of platelet-rich plasma in the treatment of carpal tunnel syndrome: A network meta-analysis of different injection treatments. Front Pharmacol. 2022 Nov 10;13:906075. doi: 10.3389/fphar.2022.906075. eCollection 2022.

    PubMed 36438824

  • Buntragulpoontawee M, Chang KV, Vitoonpong T, Pornjaksawan S, Kitisak K, Saokaew S, Kanchanasurakit S. The Effectiveness and Safety of Commonly Used Injectates for Ultrasound-Guided Hydrodissection Treatment of Peripheral Nerve Entrapment Syndromes: A Systematic Review. Front Pharmacol. 2021 Mar 5;11:621150. doi: 10.3389/fphar.2020.621150. eCollection 2020.

    PubMed 33746745

  • Senlikci HB, Afsar SI, Cosar SN, Kurtcebe AN, Ozen S, Yemisci OU. The effectiveness of single-dose blinded platelet-rich plasma (PRP) vs. corticosteroid injection in mild-to-moderate carpal tunnel syndrome: A prospective, randomized, double blind study. J Bodyw Mov Ther. 2025 Jun;42:995-1001. doi: 10.1016/j.jbmt.2025.01.057. Epub 2025 Jan 31.

    PubMed 40325784

  • Lin CP, Chang KV, Huang YK, Wu WT, Ozcakar L. Regenerative Injections Including 5% Dextrose and Platelet-Rich Plasma for the Treatment of Carpal Tunnel Syndrome: A Systematic Review and Network Meta-Analysis. Pharmaceuticals (Basel). 2020 Mar 18;13(3):49. doi: 10.3390/ph13030049.

    PubMed 32197544

  • Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.

    PubMed 30187524

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Low Molecular Weight Hyaluronic Acid and corticosteroid in people with Carpal Tunnel Syndrome (CTS), run by Minia University Hospital 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Mar 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?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Yara Assem Assem, MD (+201093383306, yara.asem@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Scores (time frame: Baseline, 1 month, and 3 months post-injection). The study lists 3 primary outcomes in all. 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 NCT07474714, which also lists 9 linked publications.

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 17 Mar 2026.

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