Hydrodissection in Carpal Tunnel Syndrome

NCT ID: NCT06188390

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

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

Study Groups

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Hyaluronic acid group

Hyaluronic acidwas injected under ultrasound guidance around wrist median nerve

Group Type EXPERIMENTAL

Ultrasound guided median nerve hydrodissection injection with Hyaluronic acid

Intervention Type PROCEDURE

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

Dextrose group

Dextrose was injected under ultrasound guidance around wrist median nerve

Group Type ACTIVE_COMPARATOR

Ultrasound guided median nerve hydrodissection injection with Dextrose water

Intervention Type PROCEDURE

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

Interventions

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Ultrasound guided median nerve hydrodissection injection with Hyaluronic acid

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

Intervention Type PROCEDURE

Ultrasound guided median nerve hydrodissection injection with Dextrose water

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Physical Medicine and Rehabilitation, Taipei Tzu chi Hospital, Buddhist Tzu chi Medical Foundation

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yi Wei Chang, MD, MS

Role: CONTACT

886-2-66289979 ext. 63521

Facility Contacts

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Yi Wei Chang, MD, MS

Role: primary

886-2-66289979 ext. 63521

References

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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/diagnostics11050849.

Reference Type RESULT
PMID: 34065073 (View on PubMed)

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.

Reference Type RESULT
PMID: 33749798 (View on PubMed)

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 Manag. 2022 Sep;12(6):687-697. doi: 10.2217/pmt-2022-0018. Epub 2022 Jul 18.

Reference Type RESULT
PMID: 35848821 (View on PubMed)

Other Identifiers

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TCRD-TPE-112-20(1/2)

Identifier Type: -

Identifier Source: org_study_id

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