Transforaminal Epidural Platelet Rich Plasma Versus Epidural Steroid Injection for Lumbosacral Radicular Pain

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.

Conditions

• Chronic Pain

Interventions

DRUG

Dexamethasone 4mg

For the transforaminal epidural injection, a 22-gauge spinal needle will be inserted coaxially via a subpedicular approach to target the upper part of the foramen under fluoroscopic guidance. Correct needle position will be confirmed with appropriate contrast spread (1ml of contrast) in the anteroposterior, oblique, and lateral view. Spread of contrast delineating the nerve root together with proximal epidural spread will be accepted as indicating correct needle position. A single level injection will be performed because there are no clinical trials showing that multilevel injections is superior to single level injection, and a well-positioned injection usually spreads to multiple levels, thus achieving the effect of multi-level injection. 2ml of 1% lignocaine will be given for skin infiltration. Once correct position is confirmed, drug injectate will be administered. For the ESI group, 8mg of dexamethasone (4mg/ml) added to 1 ml of normal saline will be given (total 3ml volume).

PROCEDURE

epidural platelet rich plasma injection

For the transforaminal epidural injection, a 22-gauge spinal needle will be inserted coaxially via a subpedicular approach to target the upper part of the foramen under fluoroscopic guidance. Correct needle position will be confirmed with appropriate contrast spread (1ml of contrast) in the anteroposterior, oblique, and lateral view. Spread of contrast delineating the nerve root together with proximal epidural spread will be accepted as indicating correct needle position. A single level injection will be performed because there are no clinical trials showing that multilevel injections is superior to single level injection, and a well-positioned injection usually spreads to multiple levels, thus achieving the effect of multi-level injection. 2ml of 1% lignocaine will be given for skin infiltration. Once correct position is confirmed, drug injectate will be administered. For the EPRP group, 3 ml of PRP will be injected. The total volume of injectate for both groups of patients is 3ml.

Sponsors & Collaborators

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Stanley SC Wong, MBBS · The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2024-03-31

Completion

2024-12-31

Countries

• Hong Kong

Study Locations