search
Back to results

Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
two-sessions of ultrasound-guided PIT
One-sessions of ultrasound-guided PIT
Placebo ultrasound-guided injection with nerve hydrodissection
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring perineural injection therapy, nerve hydrodissection

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 20-80 year-old.
  • Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

  • Cancer
  • Coagulopathy
  • Pregnancy
  • Inflammation status
  • Cervical radiculopathy
  • Polyneuropathy, brachial plexopathy
  • Thoracic outlet syndrome
  • Previously undergone wrist surgery or steroid injection for CTS

Sites / Locations

  • Department of Physical Medicine and Rehabilitation, Tri-Service General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Two-sessions of ultrasound-guided PIT

One-session of ultrasound-guided PIT

Two-session of ultrasound-guided nerve hydrodissection

Arm Description

two-sessions of ultrasound-guided PIT with 10cc 5% dextrose (3 months interval)

one-session of ultrasound-guided PIT with 10cc 5% dextrose and 10cc normal saline separately (3 months interval)

two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).

Outcomes

Primary Outcome Measures

Change from baseline of severity of symptoms and functional status on 1st, 3rd, 6th, 9th month and one year after injection
Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.

Secondary Outcome Measures

Change from baseline of pain on 1st, 3rd, 6th, 9th month and one year after injection
Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Change from baseline of cross-sectional area of the median nerve on 1st, 3rd, 6th, 9th month and one year after injection
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
Change from baseline of electrophysiological measurement on 1st, 3rd, 6th, 9th month and one year after injection
Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.

Full Information

First Posted
January 9, 2019
Last Updated
April 25, 2022
Sponsor
Tri-Service General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03802435
Brief Title
Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome
Official Title
Comparison of Long-term Effect in Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. The technique of perineural injection therapy (PIT) by using 5% dextrose (D5W) is now commonly used for peeling the nerve from surrounding soft tissue (called nerve hydrodissection), which may help antineurogenic inflammation, allow the impulse to pass, and rescue the nerve with ischemic damage. However, the evidence and reference of PIT and nerve hydrodissection are very seldom until our series researches since 2017. Moreover, our research revealed PIT with D5W is more beneficial than that of corticosteroid in patients with mild-to-moderate CTS at 4 to 6 months postinjection. However, the accumulative effect and long-term effect (more than 6 months) of PIT is still unknown. Hence, we design a randomized, double- blind, controlled trail to assess the long-term effect of ultrasound-guided PIT in patients with CTS. The aim one is to survey the possible accumulative effect of different sessions of PIT (6 months follow-up) and aim two is to evaluate the long-term effect and safety of PIT (one year follow-up).
Detailed Description
After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate CTS were includes and randomized into three groups. Group A, patients received two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval); Group B, patients received one-session of ultrasound-guided PIT with 10cc D5W and 5cc normal saline separately (3 months interval); Group C (control group), patients received two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, nerve conduction velocity of the median nerve, and Global assessment of treatment. The evaluations were performed pretreatment as well as on the 1st, 3rd, 6th, 9th month and one year after first injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
perineural injection therapy, nerve hydrodissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Two-sessions of ultrasound-guided PIT
Arm Type
Experimental
Arm Description
two-sessions of ultrasound-guided PIT with 10cc 5% dextrose (3 months interval)
Arm Title
One-session of ultrasound-guided PIT
Arm Type
Active Comparator
Arm Description
one-session of ultrasound-guided PIT with 10cc 5% dextrose and 10cc normal saline separately (3 months interval)
Arm Title
Two-session of ultrasound-guided nerve hydrodissection
Arm Type
Placebo Comparator
Arm Description
two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).
Intervention Type
Procedure
Intervention Name(s)
two-sessions of ultrasound-guided PIT
Intervention Description
two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval)
Intervention Type
Procedure
Intervention Name(s)
One-sessions of ultrasound-guided PIT
Intervention Description
One-session of ultrasound-guided PIT with 10cc D5W and 10cc normal saline separately (3 months interval)
Intervention Type
Procedure
Intervention Name(s)
Placebo ultrasound-guided injection with nerve hydrodissection
Intervention Description
Two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).
Primary Outcome Measure Information:
Title
Change from baseline of severity of symptoms and functional status on 1st, 3rd, 6th, 9th month and one year after injection
Description
Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.
Time Frame
Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection
Secondary Outcome Measure Information:
Title
Change from baseline of pain on 1st, 3rd, 6th, 9th month and one year after injection
Description
Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Time Frame
Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection
Title
Change from baseline of cross-sectional area of the median nerve on 1st, 3rd, 6th, 9th month and one year after injection
Description
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection
Title
Change from baseline of electrophysiological measurement on 1st, 3rd, 6th, 9th month and one year after injection
Description
Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 20-80 year-old. Diagnosis was confirmed using an electrophysiological study Exclusion Criteria: Cancer Coagulopathy Pregnancy Inflammation status Cervical radiculopathy Polyneuropathy, brachial plexopathy Thoracic outlet syndrome Previously undergone wrist surgery or steroid injection for CTS
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yung-Tsan Wu, MD
Phone
+886287923311
Ext
17068
Email
crwu98@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
Phone
287923311
Ext
17068
Email
crwu98@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
30339737
Citation
Wu YT, Chen SR, Li TY, Ho TY, Shen YP, Tsai CK, Chen LC. Nerve hydrodissection for carpal tunnel syndrome: A prospective, randomized, double-blind, controlled trial. Muscle Nerve. 2019 Feb;59(2):174-180. doi: 10.1002/mus.26358. Epub 2018 Dec 4.
Results Reference
result
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
result
PubMed Identifier
30187524
Citation
Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.
Results Reference
result

Learn more about this trial

Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome

We'll reach out to this number within 24 hrs