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Carpal Tunnel SyndromeNCT03031041

Comparison of Difference Hydrodissection for CTS

A study testing Ultrasound-guided short-axis hydrodissection with 5cc normal saline and Ultrasound-guided long-axis hydrodissection with 3cc normal saline 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
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Trial summary

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Ultrasound-guided short-axis hydrodissection with 5cc normal saline and Ultrasound-guided long-axis hydrodissection with 3cc normal saline
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteTaiwan
Study dates
25 Jan 2017to 30 Aug 2019
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
  • No healthy volunteers
  • 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 Difference Hydrodissection Technique in Patients With 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. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively used in clinical practice, current researches contain small participant without control group or randomized leading to foreseeable selection bias. The investigators design a randomized, double-blind, controlled trial to assess the effect of different method of ultrasound-guided hydrodissection in patients with CTS.

Read the detailed description

After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in short-axis group received one-dose ultrasound-guided hydrodissection with short-axis approach and long-axis group received one-dose ultrasound-guided injection with long-axis approach. No additional treatment after injection through the study period. 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, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 2nd, 3rd and 6th month after the treatment.

Being tested
Ultrasound-guided short-axis hydrodissection with 5cc normal saline, Ultrasound-guided long-axis hydrodissection with 3cc normal saline
Keywords
Hydrodissection, short-axis, long-axis
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.

  • Ultrasound-guided short-axis hydrodissection with 5cc normal salineProcedure or surgery

    Ultrasound-guided short-axis hydrodissection with 5cc normal saline between carpal tunnel and median nerve

  • Ultrasound-guided long-axis hydrodissection with 3cc normal salineProcedure or surgery

    Ultrasound-guided long-axis hydrodissection with 3cc normal saline between carpal tunnel and median nerve

Study groups in NCT03031041
Study groupRoleWhat they receive
Short-axis hydrodissectionExperimentalUltrasound-guided short-axis hydrodissection with normal saline between carpal tunnel and median nerve
Receives: Procedure: Ultrasound-guided short-axis hydrodissection with 5cc normal saline
Long-axis hydrodissectionActive comparatorUltrasound-guided long-axis hydrodissection with normal saline between carpal tunnel and median nerve
Receives: Procedure: Ultrasound-guided long-axis hydrodissection with 3cc normal saline

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 2nd week, 1st, 2nd, 3rd and 6th month 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, 2nd week, 1st, 2nd, 3rd and 6th month after injection

Secondary outcomes (4)

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

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

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

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

    Measured: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection

  4. Change from baseline of finger pinch on 2nd week, 1st, 2nd, 3rd and 6th month after injection

    The finger pinch strength was measured using dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch

    Measured: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month 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 posted25 Jan 2017 (estimated)
  2. Study start25 Jan 2017
  3. Primary completion30 Aug 2019
  4. Study completion30 Aug 2019

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
Single blind
Who is masked
Participant
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03031041
Sponsor's protocol ID
Difference PIT for CTS
Status last verified
Oct 2019
First submitted
21 Jan 2017
Last updated
31 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • DeLea SL, Chavez-Chiang NR, Poole JL, Norton HE, Sibbitt WL Jr, Bankhurst AD. Sonographically guided hydrodissection and corticosteroid injection for scleroderma hand. Clin Rheumatol. 2011 Jun;30(6):805-13. doi: 10.1007/s10067-010-1653-6. Epub 2011 Jan 15.

    PubMed 21234632

  • Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.

    PubMed 21623291

  • Smith J, Wisniewski SJ, Finnoff JT, Payne JM. Sonographically guided carpal tunnel injections: the ulnar approach. J Ultrasound Med. 2008 Oct;27(10):1485-90. doi: 10.7863/jum.2008.27.10.1485.

    PubMed 18809959

  • Cass SP. Ultrasound-Guided Nerve Hydrodissection: What is it? A Review of the Literature. Curr Sports Med Rep. 2016 Jan-Feb;15(1):20-2. doi: 10.1249/JSR.0000000000000226.

    PubMed 26745165

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-guided short-axis hydrodissection with 5cc normal saline and Ultrasound-guided long-axis hydrodissection with 3cc normal saline 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 31 Oct 2019. 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. 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 2nd week, 1st, 2nd, 3rd and 6th month after injection (time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month 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 NCT03031041, which also lists 4 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 31 Oct 2019.

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