Chronic Low Back Pain Clinical Trial
Official title:
A Randomized, Double-blind Controlled Trial of the Efficacy of an Intra-discal Injection of Autologous Platelet-rich Plasma (PRP) Enriched With Exosomes (PRPex) Versus Placebo in Chronic Low Back Pain
Verified date | July 2022 |
Source | Dr. Himanshu Bansal Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 therapies. intradiscal injection of PRP with exosomes derived from blood may potentially transmit some of the unique stem cell properties to other stem cells, facilitating stemness maintenance, differentiation, self-renewal, and repair. controlled, randomized, double-blind placebo clinical trial to compare the safety and efficacy of PRP with exosomes in discogenic LBP adminstartion of PRP with exosomes at the centre of the nucleus pulposus or equal amount of placebo paradiscal patients wil be elvaluated for primary Outcome measures viz: Visual analog scale (VAS), Roland Morris Disability Questionnaire (RDQ), SF 36 health questionnaire, Functional rating index and Secondary: MRI - disc degeneration grading, T2 quantification, and for any Adverse events including of discitis
Status | Completed |
Enrollment | 30 |
Est. completion date | July 25, 2022 |
Est. primary completion date | June 18, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 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 Criteria: 1. Spinal stenosis 2. An abnormal neurologic exam 3. Symptomatic compressive pathology 4. A disc herniation causing significant compression with neurologic deficit. 5. Extrusions or sequestered disk fragments 6. Any spondylolisthesis or spondylolysis. 7. Presence of a grade 5 annular fissure on discography |
Country | Name | City | State |
---|---|---|---|
India | Anupam Hospital | Rudrapur | Uttarakhand |
India | Mother Cell Spinal Injury and Stem Cell Research, Anupam Hospital | Rudrapur | Uttarakhand |
Lead Sponsor | Collaborator |
---|---|
Dr. Himanshu Bansal Foundation |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual analog scale (VAS) | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. Change in VAS score will be assessed. | Change from Baseline VAS at 1,3, 6,12 months | |
Primary | Roland Morris Disability Questionnaire (RDQ) | The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability) | Change from Baseline RDQ at 1,3,6,12 months | |
Primary | SF 36 health questionnaire | The SF.36 questionnaire (SF-36) contains 36 items that assess patients' health status and its impact on their lives. It comprises 36 questions which cover eight domains of health
Limitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions. Change in SF 36 will be assessed. |
Change from Baseline SF 36 at 1,3,6,12 months | |
Primary | Functional rating index | The Functional Rating Index (FRI) is an instrument specifically designed to quantitatively measure the subjective perception of function and pain of the spinal musculoskeletal system. Change will be assessed. | Change from Baseline Functional rating index at 1,3,6,12 months | |
Secondary | MRI | magnetic resonance imaging to quantify grading of disc degeneration. *Grades 1, 2, and 3 are based on the signal intensity of the nucleus and inner fibers of anulus. For Grade 4, the margins between the inner and other fibers of the anulus at the posterior margin of the disc are indistinct.
For Grade 5, the disc is uniformly hypointense, although there is no loss of disc space height. For Grades, 6, 7, and 8, there is progressive loss of disc space height. These could be broadly classified as mild, moderate, to severe loss of disc space height. Pfirrmann scoring Modic Grade |
Changes from baseline MRI findings will be assesed at 12 months |
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