Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain

NCT02226159 | Completed Phase 4 Results DMC

• 1 other identifier: 9086-14019
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical radicular pain is a common cause of disability and pain in the upper extremity and neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and includes relative rest, use of anti-inflammatory and analgesic medication, as well as physical therapy and home exercise. For patients who have persistent and significant symptoms, interventional pain management and surgical management are considered. Cervical epidural injections are the mainstay of the interventional, non-surgical modalities. They can be considered to provide short and long-term relief when disc herniation, foraminal stenosis or central canal stenosis pathology is identified. We are not aware of any published prospective, randomized, controlled, double-blinded studies demonstrating the efficacy of cervical transforaminal epidural steroid injections. However, the North American Spine Society (NASS) Review and Recommendation Statement states that based on the literature and expert opinion, a minimum of one or two cervical epidural steroid injections would be very appropriate in the treatment of a specific episode of cervical radicular pain. The purpose of this study is to determine the effectiveness of cervical transforaminal epidural steroid injections in decreasing the need for an operation in patients with cervical radicular pain, otherwise considered to be operative candidates.

Conditions

Pain, Radiating

Keywords

cervical; radicular pain; transforaminal epidural steroid injections

Outcome Measures

Primary Outcomes (1)

• Avoidance of Neck Surgery

  The primary outcome variable is the avoidance of surgery. Treatment success is defined as the avoidance of surgery, while treatment failure is defined as having surgery due to failure of the injection treatment to alleviate pain and improve function over the 12 months they are being followed for purposes of this study. Avoided neck surgery noted as 'Yes'; avoided neck surgery 'No' the patient had neck surgery.

  12 months after the first injection

Secondary Outcomes (12)

• Disability

  4 weeks

• Numeric Pain Scre

  4 weeks

• Patient Satisfaction

  4 weeks

• Disability

  12 weeks

• Disability

  6 Months

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Drug: Lidocaine

Lidocaine with Dexamethasone

EXPERIMENTAL

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Drug: Lidocaine with Dexamethasone

Interventions

Lidocaine DRUG

Lidocaine

Lidocaine with Dexamethasone DRUG

Also known as: Lidocaine, Dexamethasone

Lidocaine with Dexamethasone

Eligibility Criteria

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

You may qualify if:

• Subjects who have cervical radicular pain without significant neurologic deficit (neurologic deficit is defined as manual muscle testing less than 3/5), MRI/CT findings of neural compression (neural compression is defined as disc herniation or central or foraminal spinal stenosis),
• Failed 6 weeks of conservative treatment (conservative treatment is defined as relative rest, home exercise, physical therapy, and use of anti-inflammatory and/or analgesic medications),
• Deemed to be good operative candidates by spine surgeons (patients with MRI/CT findings of neural compression with concordant symptoms) and had agreed to possible operative intervention

You may not qualify if:

• History of
• acute trauma,
• diabetes (type I or type II),
• active infection
• Active progressive neurological deficit (neurologic is deficit defined as manual muscle testing less than 3/5),
• Medical condition that may affect the cervical spine neurological exam and/or pain assessment (e.g. peripheral neuropathy),
• Bilateral disease,
• More than one cervical level requiring injection,
• Bleeding disorders or other medical contraindications to the injection procedure,
• Absence of substantial radicular pain (radicular pain is defined as arm pain greater than neck pain),
• Involvement in workers' compensation claim, or any litigation related to neck injury.
• Patients who are pregnant, or who plan to become pregnant in the next 12 months

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead
• Charlotte Surgery Center: collaborator

Study Sites (1)

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Related Publications (10)

• Radhakrishnan K, Litchy WJ, O'Fallon WM, Kurland LT. Epidemiology of cervical radiculopathy. A population-based study from Rochester, Minnesota, 1976 through 1990. Brain. 1994 Apr;117 ( Pt 2):325-35. doi: 10.1093/brain/117.2.325.

  PMID: 8186959 BACKGROUND

• Stojanovic MP, Vu TN, Caneris O, Slezak J, Cohen SP, Sang CN. The role of fluoroscopy in cervical epidural steroid injections: an analysis of contrast dispersal patterns. Spine (Phila Pa 1976). 2002 Mar 1;27(5):509-14. doi: 10.1097/00007632-200203010-00011.

  PMID: 11880836 BACKGROUND

• Strub WM, Brown TA, Ying J, Hoffmann M, Ernst RJ, Bulas RV. Translaminar cervical epidural steroid injection: short-term results and factors influencing outcome. J Vasc Interv Radiol. 2007 Sep;18(9):1151-5. doi: 10.1016/j.jvir.2007.06.011.

  PMID: 17804778 BACKGROUND

• Lieberman R, Dreyfuss P, Baker R. Fluoroscopically guided interlaminar cervical epidural injections. Arch Phys Med Rehabil. 2003 Oct;84(10):1568-9; author reply 1569. doi: 10.1016/j.apmr.2003.08.072. No abstract available.

  PMID: 14594016 BACKGROUND

• Manchikanti L, Falco FJ, Diwan S, Hirsch JA, Smith HS. Cervical radicular pain: the role of interlaminar and transforaminal epidural injections. Curr Pain Headache Rep. 2014 Jan;18(1):389. doi: 10.1007/s11916-013-0389-9.

  PMID: 24338702 BACKGROUND

• Kolstad F, Leivseth G, Nygaard OP. Transforaminal steroid injections in the treatment of cervical radiculopathy. A prospective outcome study. Acta Neurochir (Wien). 2005 Oct;147(10):1065-70; discussion 1070. doi: 10.1007/s00701-005-0542-2. Epub 2005 Jun 9.

  PMID: 15924210 BACKGROUND

• Lin EL, Lieu V, Halevi L, Shamie AN, Wang JC. Cervical epidural steroid injections for symptomatic disc herniations. J Spinal Disord Tech. 2006 May;19(3):183-6. doi: 10.1097/01.bsd.0000190558.13248.e1.

  PMID: 16770215 BACKGROUND

• Lee SH, Kim KT, Kim DH, Lee BJ, Son ES, Kwack YH. Clinical outcomes of cervical radiculopathy following epidural steroid injection: a prospective study with follow-up for more than 2 years. Spine (Phila Pa 1976). 2012 May 20;37(12):1041-7. doi: 10.1097/BRS.0b013e31823b4d1f.

  PMID: 22024908 BACKGROUND

• Riew KD, Yin Y, Gilula L, Bridwell KH, Lenke LG, Lauryssen C, Goette K. The effect of nerve-root injections on the need for operative treatment of lumbar radicular pain. A prospective, randomized, controlled, double-blind study. J Bone Joint Surg Am. 2000 Nov;82(11):1589-93. doi: 10.2106/00004623-200011000-00012.

  PMID: 11097449 BACKGROUND

• Anderberg L, Annertz M, Persson L, Brandt L, Saveland H. Transforaminal steroid injections for the treatment of cervical radiculopathy: a prospective and randomised study. Eur Spine J. 2007 Mar;16(3):321-8. doi: 10.1007/s00586-006-0142-8. Epub 2006 Jul 12.

  PMID: 16835737 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Susan Odum
• Organization: OrthoCarolina Research Institute

susan.odum@orthocarolina.com

7049457710

Study Officials

• Sam Bhagia, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 27, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: December 31, 2024
• Last Updated: August 11, 2025
• Results First Posted: October 20, 2020

Record last verified: 2025-07

Locations

US (1)