The Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

The Clinical Volume Effect of Nerve Hydrodissection in Patients With Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381521
• Other study ID #: Nerve hydrodissection for CTS
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• Ultrasound-guided nerve hydrodissection
Ultrasound-guided nerve hydrodissection with 10cc normal saline between carpal tunnel and median nerve.
• 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

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital	Taipei	Neihu District

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Choi CK, Lee HS, Kwon JY, Lee WJ. Clinical implications of real-time visualized ultrasound-guided injection for the treatment of ulnar neuropathy at the elbow: a pilot study. Ann Rehabil Med. 2015 Apr;39(2):176-82. doi: 10.5535/arm.2015.39.2.176. Epub 201 — View Citation

Evers S, Thoreson AR, Smith J, Zhao C, Geske JR, Amadio PC. Ultrasound-guided hydrodissection decreases gliding resistance of the median nerve within the carpal tunnel. Muscle Nerve. 2018 Jan;57(1):25-32. doi: 10.1002/mus.25723. Epub 2017 Jul 6. — View Citation

Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd and 6th month after injection	Using the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) to measure the severity of symptoms and functional status before treatment and multiple time frame after treatment. BCTQ includes two subscale (11 questions in symptom severity and 8 questions in functional status). The scores ranged from 0 to 5 points in each question, in which zero score refered to as mildest and no difficulty in activity; five scores mean most worst severity and dysfunction.	Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
Secondary	Change from baseline of pain on 2nd week, 1st, 3rd and 6th month after injection	Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. The VAS score range from 10 (tremendously harsh pain) to 0 points (no pain)	Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
Secondary	Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd and 6th month after injection	Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.	Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
Secondary	Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd and 6th month after injection	Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.	Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection