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Carpal Tunnel SyndromeNCT02991001

The Effect of Hydrodissection for Carpal Tunnel Syndrome

A study testing Ultrasound-guided hydrodissection, Ultrasound and 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 yearsHealthy volunteers can take part
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Ultrasound-guided hydrodissection, Ultrasound and Normal Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteTaiwan
Study dates
1 Jan 2017to 15 Apr 2018
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: The Effect of Hydrodissection for 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 trail to assess the effect after 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 intervention group received one-dose ultrasound-guided hydrodissection and control side received one-dose ultrasound-guided injection at subcutaneous layer beyond carpal tunnel. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), 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 and 3rd month after the treatment.

Being tested
Ultrasound-guided hydrodissection, Placebo ultrasound-guided injection, Ultrasound, Normal Saline
Keywords
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.

  • Ultrasound-guided hydrodissectionProcedure or surgery

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

  • Placebo ultrasound-guided injectionProcedure or surgery

    Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel

  • UltrasoundDevice

  • Normal SalineDrug

Study groups in NCT02991001
Study groupRoleWhat they receive
Normal saline hydrodissectionExperimentalUltrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.
Receives: Procedure: Ultrasound-guided hydrodissection; Device: Ultrasound; Drug: Normal Saline
Normal salinePlacebo comparatorUltrasound-guided injection with normal saline at subcutaneous layer beyond the carpal tunnel region
Receives: Procedure: Placebo ultrasound-guided injection; Device: Ultrasound; Drug: 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 and 3rd month after injection

Secondary outcomes (4)

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

    Antidromic sensory nerve conduction velocity 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 and 3rd 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 posted13 Dec 2016 (estimated)
  2. Study start1 Jan 2017
  3. Primary completion15 Apr 2018
  4. Study completion15 Apr 2018

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02991001
Sponsor's protocol ID
Hydrodissection for CTS
Status last verified
Jul 2018
First submitted
9 Dec 2016
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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

  • 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

  • Choi CK, Lee HS, Kwon JY, Lee WJ. Clinical implications of real-time visualized ultrasound-guided injection for the treatment of ulnar neuropathy at the elbow: a pilot study. Ann Rehabil Med. 2015 Apr;39(2):176-82. doi: 10.5535/arm.2015.39.2.176. Epub 2015 Apr 24.

    PubMed 25932413

  • Chang KV, Hung CY, Ozcakar L. Snapping Thumb and Superficial Radial Nerve Entrapment in De Quervain Disease: Ultrasound Imaging/Guidance Revisited. Pain Med. 2015 Nov;16(11):2214-5. doi: 10.1111/pme.12867. Epub 2015 Jul 27. No abstract available.

    PubMed 26218266

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-guided hydrodissection, Ultrasound and 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 2 Aug 2018. 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 2nd week, 1st, 2nd, 3rd and 6th month after injection (time frame: Pre-treatment, 2nd week, 1st, 2nd and 3rd 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 NCT02991001, which also lists 5 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 2 Aug 2018.

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