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

NCT07474714 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 1875/02/2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Carpal Tunnel Syndrome (CTS); Hyaluronic Acid; Corticosteroid Injection; Ultrasound-Guided Injection; Median Nerve

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, 1 month, and 3 months post-injection

• 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).

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

• 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.

  Baseline, 1 month, and 3 months post-injection

Study Arms (2)

Hyaluronic Acid Group

EXPERIMENTAL

Arm Description 30 adult patients with mild to moderate idiopathic CTS receiving ultrasound-guided perineural injection of low molecular weight Hyaluronic Acid.

Drug: Low Molecular Weight Hyaluronic Acid

Corticosteroid Group

ACTIVE COMPARATOR

Arm Description 30 adult patients with mild to moderate idiopathic CTS receiving ultrasound-guided perineural injection of corticosteroids.

Drug: corticosteroid

Interventions

Low Molecular Weight Hyaluronic Acid DRUG

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

Hyaluronic Acid Group

corticosteroid DRUG

Ultrasound-guided perineural injection of corticosteroids

Corticosteroid Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University Hospital: lead

Study Sites (1)

Minia University Hosopital

Minya, 61111, Egypt

Location

Related Publications (9)

• 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.

  PMID: 31420812 BACKGROUND

• 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.

  PMID: 35571114 BACKGROUND

• 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.

  PMID: 28873284 BACKGROUND

• 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.

  PMID: 41548406 BACKGROUND

• 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.

  PMID: 36438824 BACKGROUND

• 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.

  PMID: 33746745 BACKGROUND

• 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.

  PMID: 40325784 BACKGROUND

• 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.

  PMID: 32197544 BACKGROUND

• 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.

  PMID: 30187524 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Yara Assem Assem, MD

CONTACT

+201093383306; yara.asem@mu.edu.eg

Haidy Mohamed Osman, Osman

CONTACT

+201097238632; haidy.muhamad@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Rheumatology, Rehabilitation and Physical medicine

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 16, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

EG (1)