Effect of Injection of Fat Stem Cells in Treatment of Lumbar Disorders

Phase 2

Recruiting

Conditions: Chronic discogenic low back pain.
Other intervertebral disc degeneration, lumbar region
M51.36

Registration Number: IRCT20131124015515N4

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

Patients older than 18 years; Signs of chronic discogenic pain for at least three months; Severity of pain based on VAS from 4 to above; Disability level of more than 30%; Failed to respond to traditional therapies; Local anesthetic infiltration in the facet joint / medial branches; Intervertebral disk degeneration with mean grade; Symptoms diagnostic disk with discography confirmation; Signed written informed consent to participate in the study

Exclusion Criteria

History of lumbosacral surgery; Severe disc herniation; Spinal stenosis requiring surgery; Modic type III; Evidence of spinal anesthesia in MRI; Collapse of the disc space of over 50%; Uncontrolled blood pressure despite receiving appropriate treatment; Uncontrolled diabetes despite treatment Suitable; Other serious symptomatic diseases (cancers, autoimmune disease, blood disease, kidney, liver); Pregnancy; Lactation

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Level. Timepoint: Before treatment, 1, 3, 6, 9 and 12 months after treatment. Method of measurement: visual analog scale (VAS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe).;Disability Level. Timepoint: Before treatment, 1, 3, 6, 9 and 12 months after treatment. Method of measurement: Oswestry Low Back Disability Questionnaire that disability is measured with 10 items. Each item is scored from 5-0, which indicates a higher score for the disability.

Secondary Outcome Measures