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

NCT05129085 | Unknown Phase 4

• 1 other identifier: UW20-641
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

platelet rich plasma; epidural injection; lumbosacral radicular pain; chronic pain

Outcome Measures

Primary Outcomes (1)

• Pain Score at rest

  Pain at rest assessed by numerical rating scales (NRS) from 0 to 10, where 0 = the least pain and 10 = the worst pain.

  at postoperative day 1

Secondary Outcomes (1)

• Pain Score at movement

  at postoperative day 1

Study Arms (2)

Group ESI

EXPERIMENTAL

Patients in group ESI will undergo epidural steroid injection.

Drug: Dexamethasone 4mg

Group EPRP

ACTIVE COMPARATOR

Patients in group EPRP will undergo epidural PRP injection.

Procedure: epidural platelet rich plasma injection

Interventions

Dexamethasone 4mg DRUG

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).

Also known as: epidural steroid injection

Group ESI

epidural platelet rich plasma injection PROCEDURE

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.

Also known as: epidural PRP injection

Group EPRP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Stanley SC Wong, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanley SC Wong, MBBS

CONTACT

(825)22553303; wongstan@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 22, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

HK (2)