Clinical trial NCT03031041: Comparison of Difference Hydrodissection for CTS
Official title: Comparison of Difference Hydrodissection Technique in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Hydrodissection
short-axis
long-axis
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Secondary outcomes:
measure: Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
measure: Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
measure: Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
measure: Change from baseline of finger pinch on 2nd week, 1st, 2nd, 3rd and 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
state: Neihu District
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
name: Yung-Tsan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.