AzTrials
AzTrials

Carpal Tunnel SyndromeNCT03802435

Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome

A study testing two-sessions of ultrasound-guided PIT and One-sessions of ultrasound-guided PIT in people with Carpal Tunnel Syndrome, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
two-sessions of ultrasound-guided PIT and One-sessions of ultrasound-guided PIT
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteTaiwan
Study dates
1 Aug 2019to 31 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

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

    Taipei, Neihu District, 886

Other trials in Taiwan

About this study

Official title: Comparison of Long-term Effect in 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).

Read the detailed description

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.

Being tested
two-sessions of ultrasound-guided PIT, One-sessions of ultrasound-guided PIT, Placebo ultrasound-guided injection with nerve hydrodissection
Keywords
perineural injection therapy, nerve hydrodissection
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • two-sessions of ultrasound-guided PITProcedure or surgery

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

  • One-sessions of ultrasound-guided PITProcedure or surgery

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

  • Placebo ultrasound-guided injection with nerve hydrodissectionProcedure or surgery

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

Study groups in NCT03802435
Study groupRoleWhat they receive
Two-sessions of ultrasound-guided PITExperimentaltwo-sessions of ultrasound-guided PIT with 10cc 5% dextrose (3 months interval)
Receives: Procedure: two-sessions of ultrasound-guided PIT
One-session of ultrasound-guided PITActive comparatorone-session of ultrasound-guided PIT with 10cc 5% dextrose and 10cc normal saline separately (3 months interval)
Receives: Procedure: One-sessions of ultrasound-guided PIT
Two-session of ultrasound-guided nerve hydrodissectionPlacebo comparatortwo-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).
Receives: Procedure: Placebo ultrasound-guided injection with nerve hydrodissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline of severity of symptoms and functional status on 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.

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

Secondary outcomes (3)

  1. Change from baseline of pain on 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.

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

  2. Change from baseline of cross-sectional area of the median nerve on 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.

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

  3. Change from baseline of electrophysiological measurement on 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2019
  2. Study start1 Aug 2019
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03802435
Sponsor's protocol ID
Different PIT for CTS
Status last verified
Apr 2024
First submitted
9 Jan 2019
Last updated
10 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Wu YT, Chen SR, Li TY, Ho TY, Shen YP, Tsai CK, Chen LC. Nerve hydrodissection for carpal tunnel syndrome: A prospective, randomized, double-blind, controlled trial. Muscle Nerve. 2019 Feb;59(2):174-180. doi: 10.1002/mus.26358. Epub 2018 Dec 4.

    PubMed 30339737

  • Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.

    PubMed 28778254

  • 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.

    PubMed 30187524

Questions about this trial

What is this clinical trial studying?

A study testing two-sessions of ultrasound-guided PIT and One-sessions of ultrasound-guided PIT in people with Carpal Tunnel Syndrome, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03802435, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in