Carpal Tunnel Syndrome
Conditions
Keywords
Carpal Tunnel Syndrome, recombinant human fibroblast growth factor 1
Brief summary
Carpal tunnel syndrome (CTS) is a common peripheral entrapment mononeuropathy of the upper limb, which results from compression of median nerve at level of wrist. In recent years, regenerative medicine has gradually been applied in the treatment of various degenerative conditions such as bones, muscles, and nerves. Human fibroblast growth factor 1 is a single-chain protein , which has been shown to play a crucial regulatory role in the brain and spinal cord and can facilitate nerve cell differentiation and growth. ES135 is a recombinant human fibroblast growth factor 1 (rhFGF1) which is composed of 135 amino acids with a molecular weight of approximately 15.2 kilodalton. Several studies have shown that significant improvement of Functional Independence Measure, motor and sensory function of spinal cord injury patients after ES135 treatment. One study also revealed the muscle strength have significant improvement in brachial plexus injury patients after ES135 therapy. According to above studies, the investigators hypothesized that ES135 may have benefits to CTS patients. Hence, the purpose of this study aim to demonstrate the therapeutic effects and safety of ES135 for CTS.
Detailed description
Participants established with diagnosis of mild-to-moderate CTS will been randomly assigned to ES135 or Placebo groups. With ultrasound guidance, injection with ES135 or Placebo was performed between median nerve and transcarpal ligament. The Boston Carpal Tunnel Syndrome Questionnaire is assigned as primary outcome. The secondary outcomes encompass visual analog scale, electrophysiological studies and cross-sectional area of the median nerve. The assessment is performed prior injection and at 1, 2, 3, 4 and 6 months post-injection.
Interventions
PROCEDURESono-guided injection with ES135
Sono-guided injection with ES135 between carpal tunnel and median nerve
PROCEDURESono-guided injection with placebo
Sono-guided injection with placebo between carpal tunnel and median nerve
Sponsors
Eusol Biotech Co., Ltd.
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18-80 year-old. * Diagnosis was confirmed by using an electrophysiological study * CTS symptoms for more than 3 months.
Exclusion criteria
* Severe CTS * Allergy to ES135 * Pregnancy * Inflammation status * Cervical radiculopathy * Polyneuropathy, brachial plexopathy * Thoracic outlet syndrome * Previously undergone wrist surgery or steroid/platelet-rich plasma injection for CTS within 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of severity of symptoms and functional status on 1st month, 2nd month, 3rd month,4th month, 6th month after injection. | Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month. | 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 1st month, 2nd month, 3rd month,4th month, 6th month after injection. | Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month. | Digital pain severity or paresthesia/dysesthesia 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 1st month, 2nd month, 3rd month,4th month, 6th month after injection. | Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month. | Using the musculoskeletal sonogram to measure the cross-sectional area (mm2) of the median nerve before treatment and multiple time frame after treatment |
| Change from baseline of conduction velocity, latency of median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month. | Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month. | electrophysiological study of the median nerve: Distal motor latency (ms)、Sensory nerve conduction velocity (m/s) before treatment and multiple time frame after treatment |
Countries
Taiwan
Outcome results
None listed