Transforaminal Epidural Platelet Rich Plasma Versus Epidural Steroid Injection for Lumbosacral Ra… (NCT05129085) | Clinical Trial Compass
UnknownPhase 4
Transforaminal Epidural Platelet Rich Plasma Versus Epidural Steroid Injection for Lumbosacral Radicular Pain
Hong Kong70 participantsStarted 2021-03-01
Plain-language summary
Lumbosacral radicular pain is present in around 40% of cases of low back pain. It is usually caused by irritation and inflammation of the nerve root, and patients typically experience pain radiating from the back to the lower limb in the distribution of the affected spinal nerves. Epidural steroid injection is the most commonly used pain-relieving procedure in the world. However, the analgesic efficacy of epidural steroid injection appears to be modest and duration limited. Platelet rich plasma (PRP) is an emerging treatment option for chronic pain. It is currently used for treating musculoskeletal pain conditions such as osteoarthritis and tendinopathies. While epidural steroids reduce pain by reducing inflammation, PRP promotes the healing of nerve injury and reduces neuropathic pain. However, the effect of transforaminal epidural PRP versus epidural steroid specifically for lumbosacral radicular pain is unclear. In this study, a double blind, randomized controlled trial will be performed to compare the effect of transforaminal epidural PRP versus epidural steroid for pain relief in patients with lumbosacral radicular pain.
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:
* Age 18 years or above
* average radicular leg pain of ≥ 4 (numerical rating scale (NRS) 0-10) over the past week,
* Unilateral radicular leg pain
* symptoms and/or signs of lumbosacral radicular pain (such as lower leg pain or back/buttock pain radiating to lower limb or positive straight leg raising or lower limb numbness or altered lower limb sensation)
* pain duration more than 6 weeks
* Imaging findings (magnetic resonance imaging) of a pathologic condition correlating with symptoms or signs (herniated disc or annular tear or spinal stenosis)
* able to provide informed consent
Exclusion Criteria:
* patients require surgical intervention
* coagulopathy (platelet count less than 100,000/ml, international normalized ratio \[INR\] over 1.5).
* Using anticoagulant and/or antiplatelet medication (not including aspirin)
* received epidural steroid injection within the past 1 year
* systemic infection
* previous lumbar spine surgery
* allergy: contrast dye, steroids, PRP, local anaesthetic
* pregnancy
* physically unable to tolerate epidural injection
* uncontrolled psychiatric disorder (Beck depression score ≥ 21)
* active or a history of substance use disorder (including alcohol, opioid)
* known secondary gain (eg active litigation)
* patients with predominantly neurogenic claudication (pain over the calves, buttock, and/or thigh triggered by walking and/or prolonged standing in upright position).
* back pain greater than leg pain
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.