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NCT Number: NCT03802435

Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. The technique of perineural injection therapy (PIT) by using 5% dextrose (D5W) is now commonly used for peeling the nerve from surrounding soft tissue (called nerve hydrodissection), which may help antineurogenic inflammation, allow the impulse to pass, and rescue the nerve with ischemic damage. However, the evidence and reference of PIT and nerve hydrodissection are very seldom until our series researches since 2017. Moreover, our research revealed PIT with D5W is more beneficial than that of corticosteroid in patients with mild-to-moderate CTS at 4 to 6 months postinjection. However, the accumulative effect and long-term effect (more than 6 months) of PIT is still unknown. Hence, we design a randomized, double- blind, controlled trail to assess the long-term effect of ultrasound-guided PIT in patients with CTS. The aim one is to survey the possible accumulative effect of different sessions of PIT (6 months follow-up) and aim two is to evaluate the long-term effect and safety of PIT (one year follow-up).

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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

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, 886, Taiwan

About this study

After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate CTS were includes and randomized into three groups. Group A, patients received two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval); Group B, patients received one-session of ultrasound-guided PIT with 10cc D5W and 5cc normal saline separately (3 months interval); Group C (control group), patients received two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, nerve conduction velocity of the median nerve, and Global assessment of treatment. The evaluations were performed pretreatment as well as on the 1st, 3rd, 6th, 9th month and one year after first injection.

Who can participate

Healthy volunteers accepted: Yes

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

two-sessions of ultrasound-guided PIT

Procedure

two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval)

One-sessions of ultrasound-guided PIT

Procedure

One-session of ultrasound-guided PIT with 10cc D5W and 10cc normal saline separately (3 months interval)

Placebo ultrasound-guided injection with nerve hydrodissection

Procedure

Two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).

Primary outcomes

  1. Change from baseline of severity of symptoms and functional status on 1st, 3rd, 6th, 9th month and one year after injection

    Time frame: Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection

    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 1st, 3rd, 6th, 9th month and one year after injection

    Time frame: Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection

    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 1st, 3rd, 6th, 9th month and one year after injection

    Time frame: Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection

    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 electrophysiological measurement on 1st, 3rd, 6th, 9th month and one year after injection

    Time frame: Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection

    Antidromic sensory nerve conduction velocity 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

Comparison of Long-term Effect in Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 14, 2019
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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