Carpal Tunnel Syndrome
Conditions
Keywords
Hydrodissection, hyaluronic acid
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. The hydrodissection could decrease the entrapment of nerve to restore blood supply. In addition, the hyaluronic acid was proved to decrease adhension of soft tissue and nerve during operation. The investigators design a randomized, double-blind, controlled trial to assess the effect after ultrasound-guided hydrodissection with hyaluronic acid in patients with CTS.
Detailed description
After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided hydrodissection with hyaluronic acid and control side received one-dose ultrasound-guided injection with normal saline. No additional treatment after injection through the study period. 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, 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, 3rd, 6th month and one year after the treatment.
Interventions
PROCEDURESono-guided injection with hyaluronic acid
Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2.5 ml) between carpal tunnel and median nerve
PROCEDURESono-guided injection with normal saline
Sono-guided injection with 2.5cc Normal saline (0.9%) between carpal tunnel and median nerve
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and one year after injection | Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and one year after injection | Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year | 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 2nd week, 1st, 3rd, 6th month and one year after injection | Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year | 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 conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and one year after injection | Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year | electrophysiological study of the median nerve before treatment and multiple time frame after treatment. |
| Change from baseline of finger pinch on 2nd week, 1st, 3rd, 6th month and one year after injection | Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year | The finger pinch strength was measured using dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch |
Countries
Taiwan
Outcome results
None listed