The Effect of Hyaluronic Acid for Carpal Tunnel Syndrome
- Conditions
- Carpal Tunnel Syndrome
- Interventions
- Procedure: Sono-guided injection with normal salineProcedure: Sono-guided injection with hyaluronic acid
- Registration Number
- NCT03031054
- Lead Sponsor
- Tri-Service General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- Age between 20-80 year-old.
- Diagnosis was confirmed using an electrophysiological study
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
- Polyneuropathy, brachial plexopathy
- Thoracic outlet syndrome
- Previously undergone wrist surgery or steroid injection for CTS
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal saline hydrodissection Sono-guided injection with normal saline Ultrasound-guided hydrodissection with 2.5cc normal saline between carpal tunnel and median nerve. hyaluronic acid hydrodissection Sono-guided injection with hyaluronic acid Ultrasound-guided hydrodissection with 2.5cc hyaluronic acid between carpal tunnel and median nerve.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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.
Trial Locations
- Locations (1)
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
🇨🇳Taipei, Neihu District, Taiwan