Study With Fascigel

Contipro

Status: Completed

Conditions: Back Pain

Treatments: Device: Fascigel

Study type: Interventional

Funder types: Other

Identifiers

NCT05625984

PT-FAS-1_11-21

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Fascigel injection application

Experimental group

Description:

Device is administered injected interfascially in the concerned place (low back) in multiple places laterally.

Treatment:

Device: Fascigel