AzTrials
AzTrials

Cervical RadiculopathyNCT04320836

Non-organic Signs to Predict Outcomes for Neck Pain

An observational study of Cervical Radiculopathy and Cervical Radicular Pain, run by Johns Hopkins University at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Cervical epidural steroid injection
How many people
78 participants
Where
3 sitesin 2 countries
Study dates
15 Jun 2020to 30 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites
  • Johns Hopkins

    Baltimore, Maryland, 21205

  • DC VA Medical Center

    Washington D.C., District of Columbia, 20422

Other trials in United States

South Korea1 site
  • Seoul National University

    Seoul

Other trials in South Korea

About this study

Official title: Prospective Study to Determine Evaluate the Validity and Predictive Ability of Physical Exam Signs for Cervical Radiculopathy to Predict Epidural Steroid Injection (ESI) Treatment Outcomes.

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.

Read more

The main objectives of this study are to:

  1. Determine the ability of physical exam, including non-organic signs, to predict ESI outcomes in individuals with cervical radicular pain.
  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.
Read the detailed description

Seventy-two 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.

Non-organic signs that the investigators will evaluate are:

  1. Tenderness
  2. Superficial
  3. Non-anatomical (e.g. cervical radicular pain causing tenderness in the arm or mid-back)
  4. Sham stimulation
  5. Downward pressure on head elicits neck pain
  6. With hands clasped behind neck, passive rotation of shoulders elicits neck pain
  7. Distraction
  8. Inability to rotate head > 45 degrees during overt range-of-motion testing, but significantly greater range of motion when patient is lying prone and asked to turn head to respond to physician request (e.g. sign paper, count fingers, answer question).
  9. Regional disturbances
  10. Sensory disturbances that deviate from normal neuroanatomy or pathology (e.g. single herniated disc causing pain throughout entire arm or radiating into lower back)
  11. Motor disturbances that deviate from normal neuroanatomy or pathology (e.g. dramatic non-neurological weakness, give-away weakness)
  12. Overreaction
  13. Verbal (e.g. crying, screaming)
  14. Non-verbal (e.g. exaggerated grimacing, clutching affected area, abnormally slow or rigid movements)

The investigators will evaluate MRI results to determine the precise pathology. Patients will then receive interlaminar cervical ESI. In accordance with standard practice, a Tuohy needle will be directed towards the side of the radicular pain, with correct needle position in the epidural space being confirmed with real-time contrast injection. Once the physician is satisfied with the spread, a 3 mL solution consisting of depo-methylprednisolone 40 mg + 2 mL normal saline will be injected. At Seoul National University, due to Korean healthcare regulations, the mixture will be a 3 mL solution containing 10 mg of dexamethasone and 2 mL saline. 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 average 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. Secondary outcome measures will include mean reductions in average and worst 0-10 numerical rating scale (NRS) arm pain scores over the past 7 days, mean reduction in average and worst neck pain scores, neck disability index (NDI) score, medication usage, patient global impression of change (PGIC), Hospital Anxiety and Depression Scale (HADS), Athens Insomnia Scale (AIS), Somatic Symptom Scale-8 (SSS-8), and side effects. Individuals who experience a positive categorical outcome at 4 weeks will continue to be evaluated at 12 weeks, while those with a negative outcome will exit the study.

Being tested
Cervical epidural steroid injection
Keywords
Cervicalgia, Neck pain, Cervical radiculopathy, Cervical radicular pain, Epidural steroid injection, Non-organic sign
Medical subject headings
Radiculopathy, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical epidural steroid injectionProcedure or surgery

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

Study groups in NCT04320836
Study groupRoleWhat they receive
Cervical epidural steroid injectionThis 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.
Receives: Procedure: Cervical epidural steroid injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (19)
  1. Average arm pain

    Average arm pain on 0-10 numerical rating scale.

    Measured: 4 weeks

  2. Worst arm pain

    Worst arm pain on 0-10 numerical rating scale.

    Measured: 4 weeks

  3. Average neck pain

    Average neck pain on 0-10 numerical rating scale.

    Measured: 4 weeks

  4. Worst neck pain

    Worst neck pain on 0-10 numerical rating scale.

    Measured: 4 weeks

  5. Neck disability index (NDI) score

    NDI Score on 0-10 numerical rating scale.

    Measured: 4 weeks

  6. Somatic Symptom Scale (SS-8) score

    8-question survey, out of 32 points measuring somatization.

    Measured: 4 weeks

  7. Athens Insomnia Scale (AIS) score

    8-question survey, out of 24 points measuring sleep quality.

    Measured: 4 weeks

  8. Hospital Anxiety and Depression Scale (HADS)

    14-question survey measuring anxiety and depression (each out of 21 points).

    Measured: 4 weeks

  9. Patient Global Impression of Change (PGIC) scale

    7-point Likert scale measuring patient-reported improvement.

    Measured: 4 weeks

  10. Patient Global Impression of Change (PGIC) scale

    7-point Likert scale measuring patient-reported improvement.

    Measured: 12 weeks

  11. Hospital Anxiety and Depression Scale (HADS)

    14-question survey measuring anxiety and depression (each out of 21 points).

    Measured: 12 weeks

  12. Athens Insomnia Scale (AIS) score

    8-question survey, out of 24 points measuring sleep quality.

    Measured: 12 weeks

  13. Somatic Symptom Scale (SS-8) score

    8-question survey, out of 32 points measuring somatization.

    Measured: 12 weeks

  14. Average arm pain

    Average arm pain on 0-10 numerical rating scale.

    Measured: 12 weeks

  15. Worst arm pain

    Worst arm pain on 0-10 numerical rating scale.

    Measured: 12 weeks

  16. Average neck pain

    Average neck pain on 0-10 numerical rating scale.

    Measured: 12 weeks

  17. Worst neck pain

    Worst neck pain on 0-10 numerical rating scale.

    Measured: 12 weeks

  18. Neck disability index (NDI) score

    NDI Score on 0-10 numerical rating scale.

    Measured: 12 weeks

  19. Categorical response

    Positive response is a >/= 2-point reduction in average arm pain coupled with >/= 5/7 score on patient. Anything else is a negative response.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start15 Jun 2020
  3. Primary completion30 Mar 2022
  4. Study completion30 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04320836
Sponsor's protocol ID
IRB00243203
Status last verified
Jun 2022
First submitted
23 Mar 2020
Last updated
10 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Upon request

Publications

  • 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.

    PubMed 12911018
  • 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.

    PubMed 6446157
  • 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.

    PubMed 24730436
  • 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.

    PubMed 36803892

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Radiculopathy and Cervical Radicular Pain, run by Johns Hopkins University at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Categorical response (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04320836, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in