Status:
COMPLETED
Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain
Lead Sponsor:
Dr. Himanshu Bansal Foundation
Conditions:
Chronic Low Back Pain
Degenerative Disc Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Intervertebral disc pathology accounts for 40% or more cases of chronic LBP. Available treatment options do not improve the underlying degenerative condition hence This indicates the need for new ther...
Detailed Description
Management of chronic low back pain (LBP) has contributed to its high socioeconomic The intervertebral disc accounts for 40% or more cases of chronic LBP. Available treatment options do not improve th...
Eligibility Criteria
Inclusion
- 1\. Age between18 Years to 60 Years of any sex 2. Written and signed informed consent form 3. Chronic low back pain without leg pain for more than 3 months. 2. Symptomatic moderate to severe discogenic low back pain as defined according to the following criteria: centralized chronic low back that increased with activity and lasted at least six months.
- 3\. Failure of conservative treatment measures (oral medications, rehabilitation therapy, and/or injection therapy) 4. Evidence of degeneration, as indicated via magnetic resonance imaging (MRI) decreased signal intensity on T2.
- 5\. MRI Pfirrmann (MRI) score 3-6 6. Modic Grade II change or less 7. Disk protrusion less than 5 mm on magnetic resonance imaging maintenance of 50% or more of normal disc height. An intact annulus is not required 8. Subjects must be able to attend all scheduled visits and to comply with all trial procedures
Exclusion
- Spinal stenosis
- An abnormal neurologic exam
- Symptomatic compressive pathology
- A disc herniation causing significant compression with neurologic deficit.
- Extrusions or sequestered disk fragments
- Any spondylolisthesis or spondylolysis.
- Presence of a grade 5 annular fissure on discography
Key Trial Info
Start Date :
September 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04849429
Start Date
September 10 2021
End Date
July 25 2022
Last Update
August 2 2022
Active Locations (2)
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1
Anupam Hospital
Rudrapur, Uttarakhand, India, 263153
2
Mother Cell Spinal Injury and Stem Cell Research, Anupam Hospital
Rudrapur, Uttarakhand, India, 263153