FLO for Discogenic Pain

Discogenic Back Pain Clinical Trial

Official title:

FLO Injection for Discogenic Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03644251
• Other study ID #: CLARIX-CS003
• Status: Terminated
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: March 4, 2019

Study information

• Verified date: March 2019
• Source: Tissue Tech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Discogenic pain is pain originating from a damaged vertebral disc and be caused by inflammation, dehydration of the nucleus pulposus, decreased disc height, annular tears and impaired mechanical function of the disc.Non-operative treatment may include traction, steroid therapy, methylene blue injection and ablative therapy. However, there are few high quality studies evaluating these treatments for reducing discogenic low back pain and most clinical trials failed to detect significant differences between treatments and placebo therapies. Hence, there remains an unmet clinical need.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 4, 2019
• Est. primary completion date: March 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• subject (male or female) is at least 18 to 70 years of age

• diagnosed with single level discogenic back pain confirmed by MRI and positive discography per Spine Interventional Society Guidelines

• Diagnosis of disc degeneration with Pfirrmann score of 1-3

• Subject has failed at least six months of conservative care

• Subject is symptomatic with axial lower back pain greater than lower limb pain at the intensity of >6/10 concordant or partially concordant

• The subject is able to comply with all post-operative standard of care and follow instructions.

Exclusion Criteria:

• Subjects has significant disc protrusion, severe lumbar spinal stenosis, spine tumor, severe disc degeneration, or Sacroiliac (SI) joint syndrome

• Subject had previous surgery at the disc level

• Patient has previously received injection of FLO within 3 months of screening

• The subject is unable to comply with follow-up or not appropriate for inclusion based on investigator decision

Related Conditions & MeSH terms

• Back Pain
• Discogenic Back Pain

Intervention

Other:
• amniotic and umbilical cord matrix
Cryopreserved human amniotic and umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability.

Locations

Country	Name	City	State
United States	Laser Spine Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tissue Tech Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient back pain determined by visual analog scale	0 to 100mm, 100mm worst pain	3 months
Secondary	Change in quality of life determined by SF-36	Short FormHealth Survey to evaluate quality of life across eight scales	3 and 6 months
Secondary	Change in patient back pain determined by visual analog scale	0 to 100mm, 100mm worst pain	6 months
Secondary	Change in Oswestry Disability Index	0 to 50, higher the percentile, the worse the perceived lower back pain	3 and 6 months