Carpal Tunnel Syndrome
Conditions
Keywords
platelet rich plasma, Hydrodissection
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. The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. Since 2014, three small clinical trials showed the positive effect of PRP in peripheral neuropathy included CTSin a pilot research. However, these studies have not entirely proved the effects of PRP on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP injection in patients with CTS.
Detailed description
After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control side. Participants in intervention group received one-dose ultrasound-guided PRP injection and control side received one-dose ultrasound-guided normal saline injection. 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
DRUGplatelet rich plasma
Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.
DRUGNormal saline
Ultrasound-guided 3cc normal saline injection between proximal carpal tunnel and median nerve.
DEVICEUltrasound
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
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 pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection | Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection | Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and 1 year after injection | Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection | Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the severity of 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, 3rd, 6th month and 1 year after injection | Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 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 conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection | Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection | antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment. |
| Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection | Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection | 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