Back Pain
Conditions
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.
Interventions
DEVICEFascigel
The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution.
Sponsors
Contipro Pharma a.s.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| - Pain management | 3 months | Visual Analogue Scale - 0-100 - higher scores mean a worse outcome |
Countries
Czechia
Outcome results
None listed