Trials / Completed
CompletedNCT03381521
The Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome
The Clinical Volume Effect of Nerve Hydrodissection in Patients With Carpal Tunnel Syndrome
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Tri-Service General Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. The technique of nerve hydrodissection is now commonly used for peeling the nerve from surrounding soft tissue, which may help allow the impulse to pass, and rescue the nerve with ischemic damage. However, the exact effect and interval of hydrodissection are unknown because of the lack of well-designed studies Hence, investigators design a randomized, double- blind, controlled trail to assess the therapeutic effect of ultrasound-guided nerve hydrodissection in patients with CTS.
Detailed description
After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate CTS were inclused and randomized into three groups. Group A, patients received one-session of ultrasoung-guided nerve hydrodissection with 10cc normal saline; Group B, patients received one-session of ultrasoung-guided nerve hydrodissection with 5cc normal saline; The injection syringe was covered to obscure the nature of its contents and patients were asked to turn their head away so that they would not see the procedure. As a result, patients were blinded to the treatment condition. 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 global assessment of treatment. The evaluations were performed pretreatment as well as on the 2nd week, 1st, 3rd and 6th month after injecton.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Ultrasound-guided nerve hydrodissection | Ultrasound-guided nerve hydrodissection with 10cc normal saline between carpal tunnel and median nerve. |
| PROCEDURE | Ultrasound-guided nerve hydrodissection | Ultrasound-guided nerve hydrodissection with 5cc normal saline between carpal tunnel and median nerve. |
| DEVICE | Ultrasound | The ultrasound was used to measure cross-sectional area and injection guidance |
| DRUG | Normal saline | The normal saline was used for injection solution |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2017-12-22
- Last updated
- 2023-01-13
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT03381521. Inclusion in this directory is not an endorsement.