Study With Fascigel
Not Applicable
Completed
- Conditions
- Back Pain
- Interventions
- Device: Fascigel
- Registration Number
- NCT05625984
- Lead Sponsor
- Contipro Pharma a.s.
- Brief Summary
The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution. The device intended use is to help treat back pain by lubricating fascia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
- Back pain (VAS above 4 cm)
- Limited range of motion
- Duration of pain for over 3 months
- Patient willing and able to provide the written consent
- Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study
Exclusion Criteria
- State after back surgery
- BMI > 35
- Age < 18 years
- Pregnant or lactating woman
- Patient in terminal stage of living
- Patient with known hypersensitivity or allergy to any of substances contained in Medical Device
- Patient participating in the intervention clinical study
- Alcohol or drug abuse
- Patient undergoing chronic coagulation therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fascigel injection application Fascigel Device is administered injected interfascially in the concerned place (low back) in multiple places laterally.
- Primary Outcome Measures
Name Time Method - Pain management 3 months Visual Analogue Scale - 0-100 - higher scores mean a worse outcome
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie sodium hyaluronate's fascial lubrication effects in chronic back pain management?
How does Fascigel's Class III medical device classification compare to standard-of-care injectables for lumbar facet joint pain?
Are there specific biomarkers associated with fascial adhesion resolution in hyaluronic acid-based interventional therapies?
What adverse event profiles have been reported in first-in-man trials using 1% sodium hyaluronate gel formulations?
What combination therapies with hyaluronic acid derivatives show synergistic effects in musculoskeletal pain treatment?
Trial Locations
- Locations (3)
FN Motol
🇨🇿Praha, Czechia
Medicinecare s.r.o.
🇨🇿Brno, Czechia
FN Královské Vinohrady
🇨🇿Praha, Czechia