The Effect of Hydrodissection for Patients With Carpal Tunnel Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Ultrasound-guided hydrodissection
- Conditions
- Carpal Tunnel Syndrome
- Sponsor
- Tri-Service General Hospital
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 trail to assess the effect after 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 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.
Investigators
Yung-Tsan Wu
Attending Physician of Department of Physical Medicine and Rehabilitation
Tri-Service General Hospital
Eligibility Criteria
Inclusion Criteria
- •Age between 20-80 year-old.
- •Diagnosis was confirmed using an electrophysiological study
Exclusion Criteria
- •Coagulopathy
- •Pregnancy
- •Inflammation status
- •Cervical radiculopathy
- •Polyneuropathy, brachial plexopathy
- •Thoracic outlet syndrome
- •Previously undergone wrist surgery or steroid injection for CTS
Arms & Interventions
Normal saline hydrodissection
Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.
Intervention: Ultrasound-guided hydrodissection
Normal saline hydrodissection
Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.
Intervention: Ultrasound
Normal saline hydrodissection
Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.
Intervention: Normal Saline
Normal saline
Ultrasound-guided injection with normal saline at subcutaneous layer beyond the carpal tunnel region
Intervention: Placebo ultrasound-guided injection
Normal saline
Ultrasound-guided injection with normal saline at subcutaneous layer beyond the carpal tunnel region
Intervention: Ultrasound
Normal saline
Ultrasound-guided injection with normal saline at subcutaneous layer beyond the carpal tunnel region
Intervention: Normal Saline
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- Change from baseline of pain on 2nd week, 1st, 2nd and 3rd 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 and 3rd 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 and 3rd 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 and 3rd month after injection(Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection)