The Effect and Safety of Recombinant Fibroblast Growth Factor-1 for Carpal Tunnel Syndrome

Not Applicable

Not yet recruiting

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Sono-guided injection with ES135; Procedure: Sono-guided injection with placebo

• Registration Number: NCT06328166
• Lead Sponsor: Tri-Service General Hospital

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.

Study Timeline

• Study First Submitted: 2023-12-03
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study Start: 2024-03-22
• Study First Posted: 2024-03-25
• Last Update Posted: 2024-03-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Age between 18-80 year-old.
• Diagnosis was confirmed by using an electrophysiological study
• CTS symptoms for more than 3 months.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
recombinant human fibroblast growth factor 1 (ES135)	Sono-guided injection with ES135	Ultrasound-guided injection with recombinant human fibroblast growth factor 1 (ES135) between carpal tunnel and median nerve.
normal saline	Sono-guided injection with placebo	Ultrasound-guided injection with normal saline between carpal tunnel and median nerve.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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