Chronic discogenic low back pain. Other intervertebral disc degeneration, lumbar region
Conditions
Interventions
Intervention group: Intra-discal implantation of autologous adipose-derived mesenchymal stem cells.
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Masoud Hashemi MD
Shahid Beheshti University of Medical Sciences
Outcome results
None listed