Trials / Completed
CompletedNCT02991001
The Effect of Hydrodissection for Carpal Tunnel Syndrome
The Effect of Hydrodissection for Patients With Carpal Tunnel Syndrome
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Tri-Service General Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Ultrasound-guided hydrodissection | Ultrasound-guided hydrodissection with 5cc normal saline between carpal tunnel and median nerve. |
| PROCEDURE | Placebo ultrasound-guided injection | Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel |
| DEVICE | Ultrasound | |
| DRUG | Normal Saline |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2018-04-15
- Completion
- 2018-04-15
- First posted
- 2016-12-13
- Last updated
- 2018-08-02
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT02991001. Inclusion in this directory is not an endorsement.