Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2022-10-24
2023-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fascigel injection application
Device is administered injected interfascially in the concerned place (low back) in multiple places laterally.
Fascigel
The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution.
Interventions
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Fascigel
The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Contipro Pharma a.s.
OTHER
Responsible Party
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Locations
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Medicinecare s.r.o.
Brno, , Czechia
FN Královské Vinohrady
Prague, , Czechia
FN Motol
Prague, , Czechia
Countries
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Other Identifiers
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PT-FAS-1_11-21
Identifier Type: -
Identifier Source: org_study_id
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