NCT06188390

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

August 17, 2023

Last Update Submit

December 18, 2023

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndromehydrodissectionultrasonographymedian nerve gliding

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Ultrasonography (B mode) of median nerve

    before injection , 2 weeks, 3 months and 6 months after injection.

  • Ultrasonography (duplex Doppler) of median nerve

    before injection , 2 weeks, 3 months and 6 months after injection.

  • Nerve conduction study (NCS) of median nerve

    before injection , 3 months and 6 months after injection.

Study Arms (2)

Hyaluronic acid group

EXPERIMENTAL

Hyaluronic acidwas injected under ultrasound guidance around wrist median nerve

Procedure: Ultrasound guided median nerve hydrodissection injection with Hyaluronic acid

Dextrose group

ACTIVE COMPARATOR

Dextrose was injected under ultrasound guidance around wrist median nerve

Procedure: Ultrasound guided median nerve hydrodissection injection with Dextrose water

Interventions

Ultrasound guided median nerve hydrodissection injection with Hyaluronic acidPROCEDURE

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

Hyaluronic acid group
Ultrasound guided median nerve hydrodissection injection with Dextrose waterPROCEDURE

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

Dextrose group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old patients with carpal tunnel syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

New Taipei City, 231, Taiwan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 34065073RESULT

  • 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.

    PMID: 33749798RESULT

  • 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.

    PMID: 35848821RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Yi Wei Chang, MD, MS

CONTACT

886-2-66289979vikt11010@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Hyaluronic acid and dextrose are both transparent, which is prepare by technician who is not participate in intervention and assessment
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

January 3, 2024

Study Start

January 1, 2023

Primary Completion

July 1, 2024

Study Completion

December 1, 2024

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)