NCT04320836

Brief Summary

Neck pain is the 4th leading cause of disability in the world, with approximately 50% being neuropathic in nature. Epidural steroid injections (ESI) are one of the most commonly used treatments for cervical radiculopathy. Physical exam signs, including non-organic signs, have been shown to predict outcomes for low back pain treatments, but have yet to be adequately studied for neck pain. In this prospective, observational study, 72 patients with cervical radiculopathy undergoing an initial ESI for this pain episode will undergo a comprehensive history and physical examination that includes the presence of Spurling test, midline and paraspinal tenderness, 9 non-organic tests in 5 categories, and 3 questionnaires to assess depression, anxiety, sleep, and somatization. The investigators will also evaluate patients' MRI results to determine patients' precise pathology. Patients will then receive interlaminar cervical ESI. The primary outcome measure will be the difference in the proportion of people with a positive categorical outcome, defined as a \>/= 2-point decrease in arm pain 4 weeks post-procedure coupled with a score \>/= 5 on a 7-point patient global impression of change (PGIC) scale 4 weeks post-treatment, indicating subjective improvement. The main objectives of this study are to:

  1. 1.Determine the ability of physical exam, including non-organic signs, to predict ESI outcomes in individuals with cervical radicular pain.
  2. 2.Determine the prevalence of different non-organic signs, and the association with other factors that may be associated with non-organic illness such as psychopathology and multiple unrelated pain conditions.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

1.8 years

First QC Date

March 23, 2020

Last Update Submit

June 9, 2022

Conditions

Cervical RadiculopathyCervical Radicular Pain

Keywords

CervicalgiaNeck painCervical radiculopathyCervical radicular painEpidural steroid injectionNon-organic sign

Outcome Measures

Primary Outcomes (1)

  • Categorical response

    Positive response is defined as a \>/= 2-point reduction in average arm pain coupled with \>/= 5/7 score on patient global impression of change. Anything else is a negative response.

    4 weeks

Secondary Outcomes (19)

  • Average arm pain

    4 weeks

  • Worst arm pain

    4 weeks

  • Average neck pain

    4 weeks

  • Worst neck pain

    4 weeks

  • Neck disability index (NDI) score

    4 weeks

  • +14 more secondary outcomes

Study Arms (1)

Cervical epidural steroid injection

This group will receive an interlaminar cervical ESI at C6-7 or C7-T1 with 1 mL steroid (depo-methylprednisolone 40 mg at Johns Hopkins and the DC VA Hospital or dexamethasone 10 mg at Seoul National University) and 2 mL normal saline.

Procedure: Cervical epidural steroid injection

Interventions

Cervical epidural steroid injectionPROCEDURE

Interlaminar cervical epidural steroid injection with steroid and normal saline at C6-7 and C7-T1 (standard of care).

Cervical epidural steroid injection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with clinical and MRI evidence of cervical radicular pain who are scheduled to undergo cervical epidural steroid injection

You may qualify if:

  • Age \> 18
  • Cervical radicular pain based on history and physical exam (e.g. pain radiating into one or both extremities, sensory loss, muscle weakness, Spurling's test etc.)
  • Pain duration \> 6 weeks
  • Average NRS arm pain score \> 4
  • MRI evidence of disc pathology consistent with symptoms

You may not qualify if:

  • Untreated coagulopathy
  • Previous spine surgery
  • No MRI study
  • Epidural steroid injection within past 3 years
  • Radiculopathy resulting from tumor or herpes zoster
  • Signs or symptoms or myelopathy or spinal cord compression
  • Allergic reactions to contrast allergy including macrocyclic gadolinium or depo-methylprednisolone
  • Referrals from surgery for diagnostic injections for surgical evaluation
  • Serious medical (e.g. congestive heart failure) condition that might preclude optimal outcome
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Seoul National University

Seoul, South Korea

Location

Related Publications (4)

  • Fishbain DA, Cole B, Cutler RB, Lewis J, Rosomoff HL, Rosomoff RS. A structured evidence-based review on the meaning of nonorganic physical signs: Waddell signs. Pain Med. 2003 Jun;4(2):141-81. doi: 10.1046/j.1526-4637.2003.03015.x.

    PMID: 12911018BACKGROUND

  • Waddell G, McCulloch JA, Kummel E, Venner RM. Nonorganic physical signs in low-back pain. Spine (Phila Pa 1976). 1980 Mar-Apr;5(2):117-25. doi: 10.1097/00007632-198003000-00005.

    PMID: 6446157BACKGROUND

  • Jorritsma W, Dijkstra PU, De Vries GE, Geertzen JH, Reneman MF. Physical dysfunction and nonorganic signs in patients with chronic neck pain: exploratory study into interobserver reliability and construct validity. J Orthop Sports Phys Ther. 2014 May;44(5):366-76. doi: 10.2519/jospt.2014.4715. Epub 2014 Apr 14.

    PMID: 24730436BACKGROUND

  • Cohen SP, Doshi TL, Dolomisiewicz E, Reece DE, Zhao Z, Anderson-White M, Kasuke A, Wang EJ, Hsu A, Davis SA, Yoo Y, Pasquina PF, Moon JY. Nonorganic (Behavioral) Signs and Their Association With Epidural Corticosteroid Injection Treatment Outcomes and Psychiatric Comorbidity in Cervical Radiculopathy: A Multicenter Study. Mayo Clin Proc. 2023 Jun;98(6):868-882. doi: 10.1016/j.mayocp.2022.11.022. Epub 2023 Feb 15.

    PMID: 36803892DERIVED

MeSH Terms

Conditions

RadiculopathyNeck Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven P Cohen, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

June 15, 2020

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

Upon request

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Up to 3 years after publication
Access Criteria
Upon request, contingent on objectives

Locations

US(2)KR(1)