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 range18 Years – 80 Years

SexALL

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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

What they're measuring

Pain Score at rest

Timeframe: at postoperative day 1

Trial details

NCT IDNCT05129085

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03

Contact for this trial

Stanley SC Wong, MBBS

(825)22553303 wongstan@hku.hk