Comparison of Difference Hydrodissection for CTS
1 other identifier
interventional
47
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2017
CompletedStudy Start
First participant enrolled
January 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedOctober 31, 2019
October 1, 2019
2.6 years
January 21, 2017
October 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Secondary Outcomes (4)
Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Change from baseline of finger pinch on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Study Arms (2)
Short-axis hydrodissection
EXPERIMENTALUltrasound-guided short-axis hydrodissection with normal saline between carpal tunnel and median nerve
Long-axis hydrodissection
ACTIVE COMPARATORUltrasound-guided long-axis hydrodissection with normal saline between carpal tunnel and median nerve
Interventions
Ultrasound-guided short-axis hydrodissection with 5cc normal saline between carpal tunnel and median nerve
Ultrasound-guided long-axis hydrodissection with 3cc normal saline between carpal tunnel and median nerve
Eligibility Criteria
You may qualify if:
- Age between 20-80 year-old.
- Diagnosis was confirmed using an electrophysiological study
You may not qualify if:
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
- Polyneuropathy, brachial plexopathy
- Thoracic outlet syndrome
- Previously undergone wrist surgery or steroid injection for CTS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, 886, Taiwan
Related Publications (4)
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.
PMID: 21234632BACKGROUNDMulvaney 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.
PMID: 21623291BACKGROUNDSmith 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.
PMID: 18809959RESULTCass 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.
PMID: 26745165RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yung-Tsan Wu, MD
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician of Department of Physical Medicine and Rehabilitation
Study Record Dates
First Submitted
January 21, 2017
First Posted
January 25, 2017
Study Start
January 25, 2017
Primary Completion
August 30, 2019
Study Completion
August 30, 2019
Last Updated
October 31, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share