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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinia University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low Molecular Weight Hyaluronic Acid

    Drug

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

  • corticosteroid

    Drug

    Ultrasound-guided perineural injection of corticosteroids

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Hyaluronic Acid GroupExperimental treatment 1 intervention
Group B: Corticosteroid GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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).

Time frame
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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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