The Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
5% dextrose
1cc 2% Xylocaine+4cc Triamcinolone (40mg)
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring perineural injection, ultrasound-guided, dextrose, steroid
Eligibility Criteria
Inclusion Criteria:
- Age between 20-85 year-old.
- Diagnosis was confirmed using an electrophysiological study and ultrasonography
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 Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Perineural injection with 5% dextrose
Perineural injection with steroid
Arm Description
Ultrasound-guided perineural injection with 5% Dextrose (5cc) between carpal tunnel and median nerve.
Ultrasound-guided perineural injection with 1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and median nerve.
Outcomes
Primary Outcome Measures
Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
Secondary Outcome Measures
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Change from baseline of nerve conduction velicity on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.
Full Information
NCT ID
NCT02990962
First Posted
December 9, 2016
Last Updated
April 23, 2018
Sponsor
Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02990962
Brief Title
The Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome
Official Title
The Long-term Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
4. Oversight
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. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration including steroid injection. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. The investigators design a randomized, double-blind, controlled trail to assess the effect of ultrasound-guided perineural injection with 5% dextrose in patients with CTS and compared with steroid injection.
Detailed Description
After obtaining written informed consent, patients of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with steroid. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
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, ultrasound-guided, dextrose, steroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perineural injection with 5% dextrose
Arm Type
Experimental
Arm Description
Ultrasound-guided perineural injection with 5% Dextrose (5cc) between carpal tunnel and median nerve.
Arm Title
Perineural injection with steroid
Arm Type
Active Comparator
Arm Description
Ultrasound-guided perineural injection with 1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and median nerve.
Intervention Type
Drug
Intervention Name(s)
5% dextrose
Intervention Description
Ultrasound-guided perineural injection with 5% dextrose (5cc) between carpal tunnel and surrounding median nerve with hydrodissection.
Intervention Type
Drug
Intervention Name(s)
1cc 2% Xylocaine+4cc Triamcinolone (40mg)
Intervention Description
Ultrasound-guided perineural injection with1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and surrounding median nerve with hydrodissection.
Primary Outcome Measure Information:
Title
Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Description
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Secondary Outcome Measure Information:
Title
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Description
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment
Time Frame
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Title
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Description
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Time Frame
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Title
Change from baseline of nerve conduction velicity on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Description
Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month 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 20-85 year-old.
Diagnosis was confirmed using an electrophysiological study and ultrasonography
Exclusion Criteria:
Cancer
Coagulopathy
Pregnancy
Inflammation status
Cervical radiculopathy
Polyneuropathy, brachial plexopathy
Thoracic outlet syndrome
Previously undergone wrist surgery or steroid injection for CTS
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
21623291
Citation
Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.
Results Reference
result
PubMed Identifier
15138901
Citation
Tsui BC, Wagner A, Finucane B. Electrophysiologic effect of injectates on peripheral nerve stimulation. Reg Anesth Pain Med. 2004 May-Jun;29(3):189-93. doi: 10.1016/j.rapm.2004.02.002.
Results Reference
result
PubMed Identifier
15920223
Citation
Tsui BCH, Kropelin B. The electrophysiological effect of dextrose 5% in water on single-shot peripheral nerve stimulation. Anesth Analg. 2005 Jun;100(6):1837-1839. doi: 10.1213/01.ANE.0000153020.84780.A5.
Results Reference
result
PubMed Identifier
8482993
Citation
Girlanda P, Dattola R, Venuto C, Mangiapane R, Nicolosi C, Messina C. Local steroid treatment in idiopathic carpal tunnel syndrome: short- and long-term efficacy. J Neurol. 1993;240(3):187-90. doi: 10.1007/BF00857526.
Results Reference
result
PubMed Identifier
14694502
Citation
Armstrong T, Devor W, Borschel L, Contreras R. Intracarpal steroid injection is safe and effective for short-term management of carpal tunnel syndrome. Muscle Nerve. 2004 Jan;29(1):82-8. doi: 10.1002/mus.10512.
Results Reference
result
Learn more about this trial
The Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome
We'll reach out to this number within 24 hrs