- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07474714
Hyaluronic Acid Injection in Idiopathic Carpal Tunnel Syndrome; is it Effective as Local Corticosteroids
March 14, 2026 updated by: Yara Assem, Minia University Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.).
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yara Assem Assem, MD
- Phone Number: +201093383306
- Email: yara.asem@mu.edu.eg
Study Contact Backup
- Name: Haidy Mohamed Osman, Osman
- Phone Number: +201097238632
- Email: haidy.muhamad@mu.edu.eg
Study Locations
-
-
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Minya, Egypt, 61111
- Minia University Hosopital
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Contact:
- Facility of Medicine Minia University
- Phone Number: +20862342584
- Email: dean.med@mu.edu.eg
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Sub-Investigator:
- Yara Assem, MD
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Principal Investigator:
- Haidy Mohamed Osman, MD
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Principal Investigator:
- Fatma Ali, Prof
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hyaluronic Acid Group
Arm Description 30 adult patients with mild to moderate idiopathic CTS receiving ultrasound-guided perineural injection of low molecular weight Hyaluronic Acid.
|
Ultrasound-guided perineural injection of low molecular weight Hyaluronic Acid.
|
|
Active Comparator: Corticosteroid Group
Arm Description 30 adult patients with mild to moderate idiopathic CTS receiving ultrasound-guided perineural injection of corticosteroids.
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Ultrasound-guided perineural injection of corticosteroids
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Scores
Time Frame: Baseline, 1 month, and 3 months post-injection
|
Comparison of the BCTQ scores (symptom severity and functional status) between the Hyaluronic Acid and Corticosteroid groups.
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Baseline, 1 month, and 3 months post-injection
|
|
Change in Electro-diagnostic Parameters
Time Frame: Time Frame Baseline, 1 month, and 3 months post-injection
|
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).
|
Time Frame Baseline, 1 month, and 3 months post-injection
|
|
Change in Neuromuscular Ultrasound Examination Parameters
Time Frame: Baseline, 1 month, and 3 months post-injection
|
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.
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Baseline, 1 month, and 3 months post-injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
March 9, 2026
First Submitted That Met QC Criteria
March 11, 2026
First Posted (Actual)
March 16, 2026
Study Record Updates
Last Update Posted (Actual)
March 17, 2026
Last Update Submitted That Met QC Criteria
March 14, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Median Neuropathy
- Mononeuropathies
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Carpal Tunnel Syndrome
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenal Cortex Hormones
Other Study ID Numbers
- 1875/02/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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