Back PainNCT05625984
Study With Fascigel
A study testing Fascigel in people with Back Pain, run by Contipro Pharma a.s. at 3 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- Fascigel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesCzechia
- Study dates
- 24 Oct 2022to 13 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patient participating in the intervention clinical study
- Alcohol or drug abuse
- Patient undergoing chronic coagulation therapy
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
Medicinecare s.r.o.
Brno, 602 00
FN Královské Vinohrady
Prague, 100 34
FN Motol
Prague, 150 06
About this study
Official title: Multi-centre, Open-label, First-in-man Study With Fascigel Used in Adult Patients Suffered From Back Pain
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.
- Conditions
- Back Pain
- Being tested
- Fascigel
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FascigelDevice
The product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution.
| Study group | Role | What they receive |
|---|---|---|
| Fascigel injection application | Experimental | Device is administered injected interfascially in the concerned place (low back) in multiple places laterally. Receives: Device: Fascigel |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Pain management
Visual Analogue Scale - 0-100 - higher scores mean a worse outcome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start24 Oct 2022
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contipro Pharma a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625984
- Sponsor's protocol ID
- PT-FAS-1_11-21
- Status last verified
- Feb 2024
- First submitted
- 15 Nov 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Open-label, First-in-man Study With Fascigel Used in Adult Patients Suffered From Back Pain
- ClinicalTrials.gov ID
- NCT05625984
- Acronym / sponsor ID
- PT-FAS-1_11-21
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Contipro Pharma a.s.University, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fascigel injection application | Experimental | Device: FascigelDevice is administered injected interfascially in the concerned place (low back) in multiple places laterally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- State after back surgery
- BMI > 35
- Age < 18 years
- Pregnant or lactating woman
- Patient in terminal stage of living
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FascigelThe product is a Class III Medical Device. Structure is made by 1% sodium hyaluronate polysaccharide in normal saline solution. | Device | Fascigel injection application |
Primary outcome
- Pain management
Time frame: 3 months
Visual Analogue Scale - 0-100 - higher scores mean a worse outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
Related trials for Back Pain
Recruiting
SENECA - Smart Therapies for Chronic Pain
Chronic Low Back Pain (CLBP)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain
Chronic Pain, Low Back Pain
Not yet recruiting
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
Chronic Low Back Pain (CLBP)
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascigel in people with Back Pain, run by Contipro Pharma a.s. at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Pain management (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.