This study aimed to evaluate the efficacy and safety of a comprehensive, multi-target injection protocol, termed 'PRP Spinoplasty,' for managing chronic LBP stemming from concurrent lumbar disc and facet joint disease with associated muscle spasms.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals of both sexes; ages between 18 and 80 years.
* Lower back pain consistent with lumbosacral radiculopathy, facet arthropathy, and muscle spasms.
* MRI-confirmed lumbar spine pathology (disc disease and/or facet arthropathy).
* Failure to respond to at least 3 months of conservative therapy (NSAIDS and physical therapy).
* Pain score ≥ 6; on the 10-point Numeric Pain Scale (NPS) at baseline.
Exclusion Criteria:
* Presence of local or systemic infection, or fever.
* Diagnosed with cancer within the past 12 months.
* Unable to give a consent.
* History of spinal deformity such as fracture, or severe spinal stenosis causing neurological deficit.
* Presence of lower extremity weakness or urinary tract symptoms related to spinal pathology.
* Previous spinal decompression or fusion surgery at the treatment level.
* Receipt of any spine injection within the previous 12 months.
* Use of NSAIDs within 2 weeks prior to, or 6 weeks following the procedure.
* Use of corticosteroids within 6 weeks prior, or after the procedure.
* Use of anticoagulation or antiplatelet drugs (excluding low-dose Aspirin).
* History of blood disorders.
* History of any major surgery within the past 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantifying pain intensity using Numeric Pain Scale (NPS)
Timeframe: 0-6 months
2
Assessing level of functional disability using Oswestry Disability Index (ODI)
Timeframe: 0-6 months
3
Assessing patient's condition using Single Assessment Numeric Evaluation (SANE)