The Long-term Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tri-Service General Hospital
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age between 20-85 year-old.
- •Diagnosis was confirmed using an electrophysiological study and ultrasonography
Exclusion Criteria
- •Coagulopathy
- •Pregnancy
- •Inflammation status
- •Cervical radiculopathy
- •Polyneuropathy, brachial plexopathy
- •Thoracic outlet syndrome
- •Previously undergone wrist surgery or steroid injection for CTS
Arms & Interventions
Perineural injection with 5% dextrose
Ultrasound-guided perineural injection with 5% Dextrose (5cc) between carpal tunnel and median nerve.
Intervention: 5% dextrose (Drug)
Perineural injection with steroid
Ultrasound-guided perineural injection with 1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and median nerve.
Intervention: 1cc 2% Xylocaine+4cc Triamcinolone (40mg) (Drug)
Outcomes
Primary Outcomes
Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
Time Frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
Secondary Outcomes
- Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.(Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection)
- Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.(Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection)
- Change from baseline of nerve conduction velicity on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.(Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection)
Investigators
Yung-Tsan Wu
Attending physician of physical medicine and rehabilitation
Tri-Service General Hospital