Using a growth factor injection to treat carpal tunnel syndrome
The Effect and Safety of Recombinant Human Fibroblast Growth Factor-1 for Patient with Carpal Tunnel Syndrome
NA · Tri-Service General Hospital · NCT06328166
This study is testing whether an injection of a growth factor can help people with mild-to-moderate carpal tunnel syndrome feel better and improve their nerve function.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tri-Service General Hospital (other) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06328166 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of recombinant human fibroblast growth factor 1 (ES135) for patients diagnosed with mild-to-moderate carpal tunnel syndrome (CTS). Participants will be randomly assigned to receive either the ES135 injection or a placebo, with the injection performed under ultrasound guidance. The primary outcome will be measured using the Boston Carpal Tunnel Syndrome Questionnaire, while secondary outcomes will include pain assessment, electrophysiological studies, and imaging of the median nerve over a six-month period. The study aims to evaluate the potential regenerative effects of ES135 on nerve function and symptom relief in CTS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 with a confirmed diagnosis of mild-to-moderate carpal tunnel syndrome lasting more than three months.
Not a fit: Patients with severe carpal tunnel syndrome or those who have had recent treatments for CTS may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel, non-surgical option for alleviating symptoms and improving function in patients with carpal tunnel syndrome.
How similar studies have performed: Previous studies have shown positive outcomes with similar regenerative approaches in nerve injuries, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taipei
- No. 325, Sec. 2, Chenggong Rd., Neihu Dist. — Taipei, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Yung-Tsan Wu, MD — Tri-Service General Hospital, School of Medicine, National Defense Medical Center
- Study coordinator: Yu Chi Su, MD
- Email: vickysu0110@gmail.com
- Phone: +886287923311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Carpal Tunnel Syndrome, recombinant human fibroblast growth factor 1