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Hydrodissection in Carpal Tunnel Syndrome

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06188390
Enrollment
60
Registered
2024-01-03
Start date
2023-01-01
Completion date
2024-12-31
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome, hydrodissection, ultrasonography, median nerve gliding

Brief summary

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

Detailed 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.

Interventions

PROCEDUREUltrasound guided median nerve hydrodissection injection with Hyaluronic acid

Hyaluronic acid was injected under ultrasound guidance around median nerve at the wrist

PROCEDUREUltrasound guided median nerve hydrodissection injection with Dextrose water

Dextrose water was injected under ultrasound guidance around median nerve at the wrist

Sponsors

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Hyaluronic acid and dextrose are both transparent, which is prepare by technician who is not participate in intervention and assessment

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Boston CTS (carpal tunnel syndrome) questionnairebefore injection , 2 weeks, 3 months and 6 months after injection.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.

Secondary

MeasureTime frameDescription
Ultrasonography (B mode) of median nervebefore injection , 2 weeks, 3 months and 6 months after injection.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
Ultrasonography (duplex Doppler) of median nervebefore injection , 2 weeks, 3 months and 6 months after injection.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
Nerve conduction study (NCS) of median nervebefore injection , 3 months and 6 months after injection.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

Countries

Taiwan

Contacts

Primary ContactYi Wei Chang, MD, MS
vikt11010@gmail.com886-2-66289979

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026