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NCT Number: NCT04766918

The Effect of Different Molecular Weight of HA for Carpal Tunnel Syndrome

Recently, nerve hydrodissection is utilized to assist ultrasound-guided nerve injection and studies recommend its clinical benefit for peripheral entrapment neuropathy. Hyaluronic acid (HA) can decrease the post-surgery adhesion of soft tissue and nerve but its clinical application in clinical practice is very rare.

We just proved that single HA injection have short-term effectiveness in mild-to-moderate carpal tunnel (CTS) cases and this finding may hint the therapeutic effectiveness of nerve hydrodissection for CTS depend on absorption time of solution. In addition, no study compare different weight of HA for nerve injection so far. Hence, the purpose of this study aim to compare different weight of HA for CTS and whether hydrodissection effect depend on the absorption time of solution or not.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital, School of Medicine, National Defense Medical Center

Taipei, Neihu, 886, Taiwan

About this study

Participants established with diagnosis of mild-to-moderate CTS will been randomly assigned to high molecular weight HA (Aragan Plus, 20 mg/2 ml, 3000kDa) or low molecular weight HA (ARTZDispo, 25 mg/2.5 ml, 600-1200kDa) groups. With ultrasound guidance, total two-sessions of high or low molecular weight HA with one week interval will been injected into intra-carpal region. The Boston Carpal Tunnel Syndrome Questionnaire is assigned as primary outcome. The secondary outcomes encompass visual analog scale, electrophysiological studies, cross-sectional area of the median nerve, mobility of median nerve and absorption time of HA. The assessment is performed prior injection and at 2 week, 1, 2, 3 and 6 months post-injection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 20-80 year-old.
  • Diagnosis was confirmed using an electrophysiological study

Exclusion criteria

  • Cancer
  • Coagulopathy
  • Pregnancy
  • Inflammation status
  • Cervical radiculopathy
  • Polyneuropathy, brachial plexopathy
  • Thoracic outlet syndrome
  • Previously undergone wrist surgery or steroid injection for CTS

Treatment and study plan

Sono-guided injection with high molecular weight hyaluronic acid

Procedure

Sono-guided injection with hyaluronic acid (Aragan Plus, 20 mg/2 ml, 3000kDa) between carpal tunnel and median nerve

Sono-guided injection with low molecular weight hyaluronic acid

Procedure

Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2 ml, 600-1200kDa) between carpal tunnel and median nerve

Primary outcomes

  1. Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month after injection

    Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month

    Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.

Secondary outcomes

  1. Change from baseline of pain on 2nd week, 1st, 3rd, 6th month after injection

    Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month

    Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.

  2. Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month after injection

    Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month

    Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.

  3. Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month after injection

    Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month

    electrophysiological study of the median nerve before treatment and multiple time frame after treatment.

  4. Change from baseline of mobility of median nerve on 2nd week, 1st, 3rd, 6th month after injection

    Time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month

    Using the musculoskeletal sonogram to measure the mobility of the median nerve before treatment and multiple time frame after treatment.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

The Effect of Different Molecular Weight of Hyaluronic Acid for Patients With Carpal Tunnel Syndrome

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2021
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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