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Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Triamcinolone Acetonide
Dextrose 5% in water
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Hydro-dissection, Dextrose, Corticosteroid

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presenting with carpal tunnel syndrome symptoms, including nocturnal, postural, or motion-associated paresthesias +/- pain of the median nerve distribution area in the subjective hand
  • Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree
  • Persistent symptoms for more than 3 months

Exclusion Criteria:

  • Patients with suspicious of CTS mimic condition, including cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome
  • Recent corticosteroid injection to the carpal tunnel within 6 months
  • Thenar muscle atrophy
  • Previous history of carpal tunnel surgical release
  • History of wrist trauma
  • Regular use of systemic nonsteroidal anti-inflammatory drugs, corticosteroids or diuretics
  • Pregnancy
  • Cognitive impairment

Sites / Locations

  • National Taiwan University Hospital, Bei-Hu BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrasound intracarpal corticosteroid injection

Ultrasound guided intracarpal dextrose hydro-dissection

Arm Description

Twice ultrasound-guided hydro-dissection of median nerve at carpal tunnel level. 1st injection (0 week): 40mg triamcinolone acetonide (40mg/mL ) with 4mL normal saline, 2nd injection (6 week): 5 mL normal saline

Twice ultrasound-guided hydro-dissection of median nerve at carpal tunnel level. Group B: 1st injection (0 week): 5 mL 5% dextrose, 2nd injection (6 week): 5 mL 5% dextrose

Outcomes

Primary Outcome Measures

Boston Carpal Tunnel Syndrome Questionnaire
Evaluation of symptom severity (11-question) and functional impairment (8-question) subscale. The scores range from 0 to 5 points for each question, with higher scores indicating greater severity and dysfunction.

Secondary Outcome Measures

Visual analogue scale
Pain intensity evaluation, from 0 to 10 points, a 11-point scale. The higher scores indicate severe pain.
Distal latency of median nerve sensory nerve action potential (Unit: ms)
recoding at index finger by antidromic stimulation
Amplitude of median nerve sensory nerve action potential (Unit: μV)
recording at index finger by antidromic stimulation
Distal latency of median nerve compound motor action potential (Unit: ms)
recording at abductor pollicis brevis muscle
Amplitude of median nerve compound motor action potential (Unit: mV)
recording at abductor pollicis brevis muscle
Cross-sectional area of median nerve (unit: mm2)
Ultrasound evaluation of the median nerve size
Global assessment of treatment (1st)
self-reported global assessment of treatment on 5 category (much improved, improved, no change, worse, or much worse)
Global assessment of treatment (2nd)
self-reported global assessment of treatment on 5 category (much improved, improved, no change, worse, or much worse)

Full Information

First Posted
September 27, 2020
Last Updated
December 14, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04579783
Brief Title
Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients
Official Title
Comparison of Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 27, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve entrapment of upper limb. Typical symptoms comprise pain, numbness or tingling of the thumb and index, middle or ring fingers. Thumb weakness and decreased grip strength can occur in the later stage. Currently treatments included physical modalities (low power laser, transcutaneous electrical nerve stimulation, ultrasound), medication, splinting, injection and surgery. Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization, while the injectates were diverse. Corticosteroid has been widely used for CTS for decades. However, growing evidences suggested that 5% dextrose, normal saline, platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms. Among the injectates, a single 5% dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months. However, the clinical efficacy of 5% dextrose injection has not validated by the further study. The investigators aim to compare the therapeutic effect of 5% dextrose injection with corticosteroid injection in patients with CTS, up to 12 weeks follow up.
Detailed Description
Introduction: Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve entrapment of upper limb. Typical symptoms comprise pain, numbness or tingling of the thumb and index, middle or ring fingers. Thumb weakness and decreased grip strength can occur in the later stage. Currently treatments included physical modalities (low power laser, transcutaneous electrical nerve stimulation, ultrasound), medication, splinting, injection and surgery. Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization, while the injectates were diverse. Corticosteroid has been widely used for CTS for decades. However, growing evidences suggested that 5% dextrose, normal saline, platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms. Among the injectates, a single 5% dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months. However, the clinical efficacy of 5% dextrose injection has not validated by the further study. Whether repeated injection could expand the treatment effect was undetermined. The investigators aim to compare the therapeutic effect repeated 5% dextrose injection with corticosteroid injection in patients with CTS, up to 12 weeks follow up. Material and methods: Participants: 60 adult patients (>20 year olds) with carpal tunnel syndrome, recruited from outpatient clinic. Inclusion criteria: Presenting with CTS symptoms, including nocturnal, postural, or motion-associated paresthesias +/- pain of the median nerve distribution area in the subjective hand. Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree. Persistent symptoms for more than 3 months Exclusion Criteria: Patients cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome. Recent corticosteroid injection to the carpal tunnel within 6 months. Thenar muscle atrophy. Previous history of carpal tunnel surgical release. History of wrist trauma. Regular use of systemic nonsteroidal anti-inflammatory drugs, corticosteroids or diuretics. Pregnancy. Cognitive impairment. Objective: The aim of this study is to compare the treatment effect of repeated 5 mL 5% dextrose with 5mL triamcinolone acetonide injection in patients with CTS. Detail of the intervention The study is designated as randomized, double blinded, and parallel experiment. The randomization was decided by random table in block of 4. Repeated ultrasound guided injection intracarpal median nerve hydro-dissection with 5 mL 5% dextrose (Group B) or 5mL triamcinolone acetonide injection (Group A) in patients with CTS. The regimen was shown as below: Group A: 1st injection (0 week): 40mg triamcinolone acetonide (40mg/mL) with 4mL normal saline, 2nd injection (6 week): 5 mL normal saline Group B: 1st injection (0 week): 5 mL 5% dextrose, 2nd injection (6 week): 5 mL 5% dextrose Skin infiltration with local anesthetic (lidocaine cream) at the needle insertion site was performed before the injection. Then injection was performed after sterilization. The equipment for ultrasound-guided injection will be high-resolution ultrasound machine with the linear probe. Outcome measurement: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and Visual analogue scale (VAS) before 1st injection, before 2nd injection (6-week) and 12-week after first injection. Electrophysiological evaluation (amplitude and distal latency of median nerve compound motor action potential and sensory nerve action potential); cross-sectional area of median nerve at carpal tunnel inlet, were evaluated before and 12-week after 1st injection. Global assessment of treatment was evaluated at before 2nd injection (6-week) and 12-week after first injection. Statistical analysis: Continuous variables Student's t test: fit assumption of normal distribution Mann-Whitney test: does not fit the assumption of normal distribution Categorical variables (1) Chi-square test (2) Fisher exact test: sparse data (3)Repeated-measures analysis of variance (ANOVA) was used to evaluate the effect of injection with post-hoc Bonferroni test to evaluate intra-group data at different time-frame Keywords: Hydro-dissection, corticosteroid, dextrose, carpal tunnel syndrome

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Hydro-dissection, Dextrose, Corticosteroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound intracarpal corticosteroid injection
Arm Type
Active Comparator
Arm Description
Twice ultrasound-guided hydro-dissection of median nerve at carpal tunnel level. 1st injection (0 week): 40mg triamcinolone acetonide (40mg/mL ) with 4mL normal saline, 2nd injection (6 week): 5 mL normal saline
Arm Title
Ultrasound guided intracarpal dextrose hydro-dissection
Arm Type
Active Comparator
Arm Description
Twice ultrasound-guided hydro-dissection of median nerve at carpal tunnel level. Group B: 1st injection (0 week): 5 mL 5% dextrose, 2nd injection (6 week): 5 mL 5% dextrose
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Shincort
Intervention Description
Group A: 40mg triamcinolone acetonide (1mL) + 4mL normal saline
Intervention Type
Drug
Intervention Name(s)
Dextrose 5% in water
Other Intervention Name(s)
Vitagen
Intervention Description
Group B: 5mL 5% dextrose
Primary Outcome Measure Information:
Title
Boston Carpal Tunnel Syndrome Questionnaire
Description
Evaluation of symptom severity (11-question) and functional impairment (8-question) subscale. The scores range from 0 to 5 points for each question, with higher scores indicating greater severity and dysfunction.
Time Frame
Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
Pain intensity evaluation, from 0 to 10 points, a 11-point scale. The higher scores indicate severe pain.
Time Frame
Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))
Title
Distal latency of median nerve sensory nerve action potential (Unit: ms)
Description
recoding at index finger by antidromic stimulation
Time Frame
change of the score between 12 weeks and baseline (1st injection)
Title
Amplitude of median nerve sensory nerve action potential (Unit: μV)
Description
recording at index finger by antidromic stimulation
Time Frame
change of the score between 12 weeks and baseline (1st injection)
Title
Distal latency of median nerve compound motor action potential (Unit: ms)
Description
recording at abductor pollicis brevis muscle
Time Frame
change of the score between 12 weeks and baseline (1st injection)
Title
Amplitude of median nerve compound motor action potential (Unit: mV)
Description
recording at abductor pollicis brevis muscle
Time Frame
change of the score between 12 weeks and baseline (1st injection)
Title
Cross-sectional area of median nerve (unit: mm2)
Description
Ultrasound evaluation of the median nerve size
Time Frame
Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))
Title
Global assessment of treatment (1st)
Description
self-reported global assessment of treatment on 5 category (much improved, improved, no change, worse, or much worse)
Time Frame
6-week after 1st injection (before 2nd injection)
Title
Global assessment of treatment (2nd)
Description
self-reported global assessment of treatment on 5 category (much improved, improved, no change, worse, or much worse)
Time Frame
6-week after 2nd injection (12-week after 1st injection)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presenting with carpal tunnel syndrome symptoms, including nocturnal, postural, or motion-associated paresthesias +/- pain of the median nerve distribution area in the subjective hand Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree Persistent symptoms for more than 3 months Exclusion Criteria: Patients with suspicious of CTS mimic condition, including cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome Recent corticosteroid injection to the carpal tunnel within 6 months Thenar muscle atrophy Previous history of carpal tunnel surgical release History of wrist trauma Regular use of systemic nonsteroidal anti-inflammatory drugs, corticosteroids or diuretics Pregnancy Cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ke-Vin Chang, MD, PhD
Phone
+886-2-23712121
Ext
5309
Email
kvchang011@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ke-Vin Chang, MD,PhD
Organizational Affiliation
National Taiwan University Hospital Beihu Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital, Bei-Hu Branch
City
Taipei
State/Province
Wanhua District
ZIP/Postal Code
108
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke-Vin Chang, MD, PhD
Email
kvchang011@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28778254
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.2017.05.025.
Results Reference
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Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients

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