Actively Recruiting
Evaluation of Dynavisc for Pain Reduction Following Revision Surgery in Persistent or Recurrent Carpal Tunnel Syndrome
Led by FzioMed · Updated on 2026-04-06
50
Participants Needed
4
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of DYNAVISC in adults diagnosed with persistent or recurrent carpal tunnel syndrome after previous surgery. This prospective, multicenter, randomized, and evaluator-blinded clinical trial compares two methods for protecting the median nerve during revision surgery: standard surgery followed by DYNAVISC application and standard surgery followed by coverage with a hypothenar fat pad flap. Participants will receive revision surgery, after which half will have DYNAVISC (1 ml) applied around the median nerve by the surgeon, while the other half will have the nerve covered with a hypothenar fat pad flap. Following surgery, participants will begin gentle wrist and finger movements immediately and gradually increase activity to more strenuous movements starting six weeks after surgery. Follow-up visits for hand evaluations are scheduled at 1 week, 4 weeks, and 12 weeks post-surgery. Throughout the study, participants will report pain levels using a visual analog scale (VAS), hand function using the Quick DASH Score, neuropathic pain using the DN4 assessment, and undergo nerve conduction tests with electroneuromyography. Grip strength will be measured with a dynamometer. All assessments will occur at baseline and follow-up visits with evaluators unaware of the treatment group. The main outcome is pain reduction at 12 weeks post-surgery, with additional measures of hand function, nerve recovery, and strength also monitored.
CONDITIONS
Brief Title
Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and available for study duration
- Aged 18 to 65 years
- In good general health
- Experiencing recurrence or persistence of pain in the same hand after previous carpal tunnel release surgery
- Positive result on at least one physical exam test: Phalen, Tinel's, or monofilament test
- ENMG confirms median nerve velocity and deviation consistent with carpal tunnel syndrome
You will not qualify if you...
- Unable to understand the trial or sign consent
- Unable or unwilling to attend all study visits and data collections
- Active infection requiring medication
- Taking medication for diabetes mellitus
- Having collagen disorders
- Taking medication for hypothyroidism
- Taking medication for rheumatoid arthritis
- Taking medication for autoimmune disease
- Cervical nerve compression
- Hematopoietic disorders
- Lacertus fibrosis
- Psychiatric disorder requiring medical treatment
- Subject of workers compensation claim
- History of cancer except basal or squamous cell skin cancer
- Known allergy to Dynavisc components
- Currently participating in another clinical trial
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo revision surgery for persistent or recurrent carpal tunnel syndrome. The median nerve is treated either with Dynavisc applied by the surgeon or with a hypothenar fat pad flap as standard of care.
1 visit (in-person)
Duration - 12 weeks
Participants gently mobilize their wrist and fingers immediately after surgery, with strenuous movements allowed starting 6 weeks post-surgery. Their hand will be evaluated at 1 week, 4 weeks, and 12 weeks following surgery for pain, hand function, nerve recovery, and grip strength.
3 visits (in-person) at 1, 4, and 12 weeks post-surgery
Trial Site Locations
Total: 4 locations
1
UZ Leuven
Leuven, Belgium, Belgium, 3000
Actively Recruiting
2
AZ Delta
Roeselare, Belgium, Belgium, 8800
Actively Recruiting
3
Hospital Angelina Caron
Araçatuba, Brazil, Brazil, 83430-973
Actively Recruiting
4
Azienda Ospedale Universita Padova
Padova, Italy, Italy, 35128
Actively Recruiting
Research Team
G
Gere diZerega, MD
S
Stephanie Cortese, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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