Hydrodissection in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Comparing Efficacy of Hydrodissection With Hyaluronic Acid vs 5% Dextrose for Carpal Tunnel Syndrome: A Randomized Controlled Trial and Ultrasonographic Evaluation of Median Nerve Gliding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06188390
• Other study ID #: TCRD-TPE-112-20(1/2)
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: Yi Wei Chang, MD, MS
• Phone: 886-2-66289979
• Email: vikt11010[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the efficacy on carpal tunnel syndrome (CTS) treatment between hydrodissection with hyaluronic acid (HA) vs 5% dextrose

Description:

Compare the efficacy on carpal tunnel syndrome treatment between hydrodissection with hyaluronic acid vs 5% dextrose through ultrasonographic evaluation.; 2) Evaluate the association of median nerve gliding results between using duplex Doppler ultrasound and B mode video with cross-correlation algorithm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 20-80 years old patients with carpal tunnel syndrome

Exclusion Criteria:

• pregnancy, Diabetes, hypothyroidism, uremia, rheumatoid arthritis, coagulopathy, cervical radiculopathy and patients who has ever received surgery for carpal tunnel syndrome or wrist fracture

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• Ultrasound guided median nerve hydrodissection injection with Hyaluronic acid
Hyaluronic acid was injected under ultrasound guidance around median nerve at the wrist
• Ultrasound guided median nerve hydrodissection injection with Dextrose water
Dextrose water was injected under ultrasound guidance around median nerve at the wrist

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, Taipei Tzu chi Hospital, Buddhist Tzu chi Medical Foundation	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Babaei-Ghazani A, Moradnia S, Azar M, Forogh B, Ahadi T, Chaibakhsh S, Khodabandeh M, Eftekharsadat B. Ultrasound-guided 5% dextrose prolotherapy versus corticosteroid injection in carpal tunnel syndrome: a randomized, controlled clinical trial. Pain Mana — View Citation

Lin MT, Liu IC, Syu WT, Kuo PL, Wu CH. Effect of Perineural Injection with Different Dextrose Volumes on Median Nerve Size, Elasticity and Mobility in Hands with Carpal Tunnel Syndrome. Diagnostics (Basel). 2021 May 9;11(5):849. doi: 10.3390/diagnostics11 — View Citation

Su YC, Shen YP, Li TY, Ho TY, Chen LC, Wu YT. The Efficacy of Hyaluronic Acid for Carpal Tunnel Syndrome: A Randomized Double-Blind Clinical Trial. Pain Med. 2021 Nov 26;22(11):2676-2685. doi: 10.1093/pm/pnab109. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston CTS (carpal tunnel syndrome) questionnaire	The Boston CTS questionnaire is self-administered and is composed of two parts: the symptom severity scale (11 questions) and the functional status scale (8 questions).A final score is calculated for each scale (the sum of the individual scores divided by the number of items) and ranges from 1 to 5, with a higher score indicating a more severe handicap.	before injection , 2 weeks, 3 months and 6 months after injection.
Secondary	Ultrasonography (B mode) of median nerve	Transverse ultrasonograms were obtained at the level of pisiform bone. Using electronic calipers, the CSA of the median nerve was measured by tracing the margin of the inner border of the perineural hyperechogenic rim that surrounded the hypoechoic median nerve , unit : mm2	before injection , 2 weeks, 3 months and 6 months after injection.
Secondary	Ultrasonography (duplex Doppler) of median nerve	An ultrasonography probe was placed longitudinally at the level of the lunate-capitate intercarpal joint to obtain a clear image of the median nerve. Longitudinal gliding excursions of the median nerve and flexor tendon were recorded using Doppler ultrasonography. The saved images were transferred to a personal coputer and analyzed by a researcher who was unaware of the individual and group identity of each image	before injection , 2 weeks, 3 months and 6 months after injection.
Secondary	Nerve conduction study (NCS) of median nerve	Distal motor latencies of the median and ulnar nerve were respectively measured by placing a stimulating electrode at the wrist and a recording electrode 8 cm away from the stimulating electrode on the abductor pollicis brevis muscle and the adductor digiti minimi muscle. For sensory NCSs of the median and ulnar nerves, a standard distance of 14 cm was maintained between the stimulating electrode at the wrist and the recording electrodes at the ring finger on radial and ulnar sides	before injection , 3 months and 6 months after injection.